MSS, RAS-mutant Colorectal Cancer
Conditions
Keywords
cancer
Brief summary
This is a multicenter, open-label, Phase 1B/2 study to evaluate the safety and assess the preliminary anti-tumor activity of binimetinib administered in combination with nivolumab or nivolumab + ipilimumab in adult patients with advanced metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) disease and presence of a RAS mutation that have received at least one prior line of therapy and no more than 2 prior lines of therapy. The study contains a Phase 1b period to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) and schedule of binimetinib followed by a randomized Phase 2 period to assess the efficacy of the combinations.
Interventions
Orally, twice daily.
Intravenously (IV) every 4 weeks (Q4W)
intravenously (IV) every 8 weeks (Q8W)
Sponsors
Study design
Intervention model description
In phase 1 it is sequential and then in phase 2 it is parallel.
Eligibility
Inclusion criteria
Key Inclusion Criteria * Measurable, histologically/cytologically confirmed metastatic colorectal cancer (mCRC). * Able to provide a sufficient amount of representative tumor specimen for central laboratory testing of RAS mutation status and microsatellite stable (MSS). * If a fresh tissue sample is provided, a blood sample is required. * Metastatic colorectal cancer (mCRC) categorized as microsatellite stable (MSS) by polymerase chain reaction (PCR) per local assay at any time prior to Screening or by the central laboratory. * RAS mutation per local assay at any time prior to Screening or by the central laboratory. * Have received at least 1 prior line of therapy and meets at least one of the following criteria: * were unable to tolerate the prior first-line regimen * experienced disease progression during or after prior first-line regimen for metastatic disease * progressed during or within 3 months of completing adjuvant chemotherapy. Note: Generally, treatments that are separated by an event of progression are considered different regimens. * Have received no more than 2 prior lines of therapy (maintenance therapy given in the metastatic setting will not be considered a separate regimen). Generally, treatments that are separated by an event of progression are considered different regimens. * Adequate bone marrow, cardiac, kidney and liver function * Able to take oral medications * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Female patients are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy from screening through follow-up if of child-bearing potential * Non-sterile male patients who are sexually active with female partners of childbearing potential must agree to follow instructions for acceptable or highly effective method(s) of contraception for the duration of study treatment and for 7 months after the last dose of study treatment with nivolumab Key
Exclusion criteria
* Prior treatment with any MEK inhibitor, an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. * Any untreated central nervous system (CNS) lesion. * Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * Known history of retinal vein occlusion (RVO). * Known history of Gilbert's syndrome. * Pregnant or breastfeeding females. * Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to first day of study treatment: * History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli. * Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy. * Concurrent neuromuscular disorder that is associated with the potential of elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy). * History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes). * Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be performed at sites where mandated locally. * Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection, and/or detectable virus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) | Cycle 1: Day 1 up to Day 28 | DLT:Adverse event(AE)/abnormal laboratory assessed unrelated-disease,disease progression,intercurrent illness/concomitant medication/therapies resulting inability tolerate 75% dose intensity in Cycle 1.Total bilirubin(TBL)grade(G)\>=3 (\>3.0\*upper limit of normal\[ULN)\]);AST/ALT\>5-8\*ULN\>5 days,\>8\*ULN,\>3\*ULN concurrent TBL\>2\*ULN;G\>=3 serum creatinine,CK elevation,ECG QTcF prolonged,G3 troponin,electrolyte\>72 hours,G3/4 amylase/lipase.G4 ANC,platelet count\>7 days;G3/4 platelet count,other AE except lymphopenia.G\>=3 retinopathy,other disorder\>21 days;G2 uveitis/eye pain/blurred vision/decreased visual acuity;G4 other disorder.Decrease LVEF\>10% G\>=3 cardiac disorders.G3/4 hypertension.G3 fatigue\>=7 days,hypersensitivity,infusion reaction,fever\>=72 hours/hemodynamic compromise,endocrinopathy.G\>=2 interstitial lung disease/pneumonitis;G3 bronchospasm.G3/4 rash,hand foot skin reaction,photosensitivity.G3 colitis;G3/4 diarrhea,nausea/vomiting.Neurologic G3.Other hematologic/nonhematolic G\>=3 AE. |
| Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 2: maximum up to 26 months approximately) | ORR was defined as the percentage of participants who achieved a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator per RECIST v1.1. As per RECIST v1.1, CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<)10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was considered progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Response as Per RECIST v1.1 | From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately and Phase 2: maximum up to 26 months approximately) | Complete response as per RECIST v1.1 was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (Phase 1b: maximum up to 9 months approximately and Phase 2: maximum up to 26 months approximately) | AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs: events between first dose of study drug and up to 30 days after last dose or before start of new anticancer therapy minus 1 day, whichever occurred first. TEAE graded by CTCAE grade 4.03: Grade 3: severe/medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care activities of daily living (ADL); Grade 4: life-threatening consequence, urgent intervention indicated. In this outcome measure, number of participants with 'all grades' and 'Grade 3/4' were reported. |
| Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Hematological parameters included: Hemoglobin graded high, Hemoglobin graded low, Platelets count graded low, White Blood Cell (WBC) graded high, WBC graded low, Neutrophils graded low, Lymphocytes graded high, Lymphocytes graded low. Coagulation parameters included: International Normalized Ratio (INR) graded high, Activated Partial Thromboplastin Time (aPTT) graded high. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. A grade 0 was assigned for all non-missing values not graded as 1 or higher. If value was graded \>=1 but falls within the normal range, the grade was reset to 0. Categories with at least 1 non-zero data values are reported. |
| Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Hematology parameters: Basophils, Eosinophils, Hematocrit, Monocytes, Red blood cells (RBC). Coagulation parameters: Prothrombin Time. Laboratory values were as per laboratory normal ranges. Values above range were reported as high and values below range as low. Laboratory parameters were graded based on laboratory normal ranges as low, normal, high and missing are reported in this outcome measure. Categories with at least 1 non-zero data values are reported. |
| Phase 1b: Objective Response Rate (ORR) Per RECIST v1.1 | From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately) | ORR was defined as the percentage of participants who achieved a BOR of CR or PR as determined by investigator per RECIST v1.1. As per RECIST v1.1, CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. |
| Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Chemistry laboratory parameters: Blood urea nitrogen (BUN), Total protein, Chloride, Cancer antigen 19-9 (CA 19-9), Brain natriuretic peptide (BNP), Bicarbonate, Direct bilirubin, Carcinoembryonic antigen (CEA), Lactate dehydrogenase (LDH), Uric acid, Troponin I. Thyroid panel laboratory parameters: Thyroid-stimulating hormone (TSH), Free triiodothyronine (T3), Free thyroxine (T4). Laboratory values were as per laboratory normal ranges. Values above range were reported as high and values below range as low. Shift in chemistry and thyroid panel severity from baseline grade low, normal, high and missing to the post baseline grades as low, normal, high and missing are reported in this outcome measure. Categories with at least 1 non-zero data values are reported. |
| Number of Participants With Abnormal Hepatic Laboratory Values | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Criteria for abnormal hepatic laboratory parameters: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT): \>3\* upper limit of normal (ULN), \>5\*ULN, \>8\*ULN, \>10\*ULN, \>20\*ULN; Total bilirubin (TBL) \>1.5\*ULN, \>2\*ULN; Alkaline phosphatase (ALP) \>2\*ULN, \>3\*ULN. Categories with at least 1 non-zero data values are reported. |
| Concentration Versus Time Summary of Plasma Concentration of Binimetinib | 1.5 hours post dose of binimetinib on Day 1, 15 of Cycle 1; pre dose of binimetinib on Day 15 of Cycle 1, 2, 3, 4, 5 | — |
| Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately) | Abnormalities: Albumin graded low, Alkaline phosphatase (ALP) graded high, Alanine aminotransferase (ALT) graded high, Aspartate aminotransferase (AST) graded high, Bilirubin graded high, Amylase graded high, Creatinine graded high, Corrected calcium graded high, Creatine Kinase (CK) graded high, Glucose graded high, Glucose graded low, Lipase graded high, Magnesium graded high, Magnesium graded low, Potassium graded high, Potassium graded low, Sodium graded high and Sodium graded low. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. A grade 0 was assigned for all non-missing values not graded as 1 or higher. If value was graded \>=1 but falls within the normal range, the grade was reset to 0. Categories with at least 1 non-zero data values are reported. |
| Duration of Response (DOR) as Per RECIST v1.1 | From date of first documented CR/PR to date of first documented PD, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately, Phase 2: maximum up to 26 months approximately) | DOR was defined as the time between the date of the first documented confirmed response (PR or CR) and the date of the first documented progression or death due to any cause. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures \<10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters. PD was defined as at least 20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. |
Countries
Belgium, Netherlands, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
This study included 2 phases: Phase 1b and Phase 2. The recommended dose for Phase 2 (RP2D) of binimetinib was determined in Phase 1b (dose finding phase).
Participants by arm
| Arm | Count |
|---|---|
| Phase 1b: Nivolumab+Binimetinib Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received binimetinib at a starting dose of 45 mg tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Binimetinib dose modification to intermitted dosing (3 weeks on treatment and 1 week off treatment) with 45 mg dose or dose reduction to 30 mg BID or 30 mg intermittent dosing based on investigator's decision as per its tolerability among participants. Participants then followed up for safety for around 150 days. | 10 |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received binimetinib at a starting dose of 45 mg tablet BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Ipilimumab was administered at the dose of 1 mg/kg IV every 8 weeks after completion of nivolumab infusion. Binimetinib dose modification to intermitted dosing (3 weeks on treatment and 1 week off treatment) with 45 mg dose or dose reduction to 30 mg BID or 30 mg intermittent dosing based on investigator's decision as per its tolerability among participants. Participants then followed up for safety for around 150 days. | 11 |
| Phase 2: Nivolumab+Binimetinib Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received 45 mg binimetinib tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle, until disease progression, unacceptable toxicity, withdrawal of informal consent, initiation of subsequent anticancer therapy, lost to follow-up or death. Participants then followed up for safety for around 150 days. | 27 |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib Participants with previously treated MSS metastatic colorectal cancer with RAS mutation received 45 mg binimetinib tablet orally BID along with 480 mg IV dose of nivolumab every 4 weeks in each 28 day treatment cycle. Ipilimumab was administered at the dose of 1 mg/kg IV every 8 weeks after completion of nivolumab infusion until disease progression, unacceptable toxicity, withdrawal of informal consent, initiation of subsequent anticancer therapy, lost to follow-up or death. Participants then followed up for safety for around 150 days. | 27 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Phase 1b: Dose Finding Period | Completed follow-up per protocol | 1 | 1 | 0 | 0 |
| Phase 1b: Dose Finding Period | Death | 8 | 8 | 0 | 0 |
| Phase 1b: Dose Finding Period | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Phase 1b: Dose Finding Period | Withdrawal by Subject | 0 | 2 | 0 | 0 |
| Randomized Phase 2 Period | Completed follow-up per protocol | 0 | 0 | 0 | 4 |
| Randomized Phase 2 Period | Death | 0 | 0 | 20 | 21 |
| Randomized Phase 2 Period | Lost to Follow-up | 0 | 0 | 2 | 1 |
| Randomized Phase 2 Period | Other | 0 | 0 | 0 | 1 |
| Randomized Phase 2 Period | Withdrawal by Subject | 0 | 0 | 5 | 0 |
Baseline characteristics
| Characteristic | Phase 1b: Nivolumab+Binimetinib | Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Phase 2: Nivolumab+Binimetinib | Phase 2: Nivolumab+Ipilimumab+Binimetinib | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 8 Participants | 7 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 9 Participants | 19 Participants | 20 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 11 Participants | 21 Participants | 23 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 9 Participants | 11 Participants | 21 Participants | 23 Participants | 64 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 11 Participants | 10 Participants | 27 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 16 Participants | 17 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 10 | 8 / 11 | 20 / 27 | 21 / 27 |
| other Total, other adverse events | 10 / 10 | 11 / 11 | 27 / 27 | 27 / 27 |
| serious Total, serious adverse events | 5 / 10 | 6 / 11 | 12 / 27 | 11 / 27 |
Outcome results
Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT)
DLT:Adverse event(AE)/abnormal laboratory assessed unrelated-disease,disease progression,intercurrent illness/concomitant medication/therapies resulting inability tolerate 75% dose intensity in Cycle 1.Total bilirubin(TBL)grade(G)\>=3 (\>3.0\*upper limit of normal\[ULN)\]);AST/ALT\>5-8\*ULN\>5 days,\>8\*ULN,\>3\*ULN concurrent TBL\>2\*ULN;G\>=3 serum creatinine,CK elevation,ECG QTcF prolonged,G3 troponin,electrolyte\>72 hours,G3/4 amylase/lipase.G4 ANC,platelet count\>7 days;G3/4 platelet count,other AE except lymphopenia.G\>=3 retinopathy,other disorder\>21 days;G2 uveitis/eye pain/blurred vision/decreased visual acuity;G4 other disorder.Decrease LVEF\>10% G\>=3 cardiac disorders.G3/4 hypertension.G3 fatigue\>=7 days,hypersensitivity,infusion reaction,fever\>=72 hours/hemodynamic compromise,endocrinopathy.G\>=2 interstitial lung disease/pneumonitis;G3 bronchospasm.G3/4 rash,hand foot skin reaction,photosensitivity.G3 colitis;G3/4 diarrhea,nausea/vomiting.Neurologic G3.Other hematologic/nonhematolic G\>=3 AE.
Time frame: Cycle 1: Day 1 up to Day 28
Population: Dose-Determining Set (DDS) included all participants in Phase 1b who experienced a DLT or receive at least 75% of the planned binimetinib dose intensity during Cycle 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1b: Nivolumab+Binimetinib | Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) | 2 Participants |
Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator per RECIST v1.1. As per RECIST v1.1, CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<)10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was considered progression.
Time frame: From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 2: maximum up to 26 months approximately)
Population: All participants randomized to study treatment in Phase 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b: Nivolumab+Binimetinib | Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 0.0 Percentage of participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 7.4 Percentage of participants |
Concentration Versus Time Summary of Plasma Concentration of Binimetinib
Time frame: 1.5 hours post dose of binimetinib on Day 1, 15 of Cycle 1; pre dose of binimetinib on Day 15 of Cycle 1, 2, 3, 4, 5
Population: The pharmacokinetic analysis set included of all participants who received at least 1 dose of binimetinib and have at least one evaluable bioanalytical result. Here Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1b: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 1 Day 1: 1.5 Hours post dose | 228 nanogram per milliliter | Geometric Coefficient of Variation 152.2 |
| Phase 1b: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 1 Day 15: 1.5 Hours post dose | 542 nanogram per milliliter | Geometric Coefficient of Variation 57.6 |
| Phase 1b: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 4 Day 15: pre dose | NA nanogram per milliliter | — |
| Phase 1b: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 2 Day 15: pre dose | 108 nanogram per milliliter | Geometric Coefficient of Variation 52.9 |
| Phase 1b: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 1 Day 15: pre dose | 135 nanogram per milliliter | Geometric Coefficient of Variation 60.9 |
| Phase 1b: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 5 Day 15: pre dose | NA nanogram per milliliter | — |
| Phase 1b: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 3 Day 15: pre dose | 140 nanogram per milliliter | Geometric Coefficient of Variation 42 |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 2 Day 15: pre dose | NA nanogram per milliliter | — |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 1 Day 1: 1.5 Hours post dose | 163 nanogram per milliliter | Geometric Coefficient of Variation 129.6 |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 1 Day 15: pre dose | 125 nanogram per milliliter | Geometric Coefficient of Variation 103.9 |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 1 Day 15: 1.5 Hours post dose | 414 nanogram per milliliter | Geometric Coefficient of Variation 24.5 |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 3 Day 15: pre dose | NA nanogram per milliliter | — |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 4 Day 15: pre dose | NA nanogram per milliliter | — |
| Phase 2: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 1 Day 15: pre dose | 77.0 nanogram per milliliter | Geometric Coefficient of Variation 141.2 |
| Phase 2: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 5 Day 15: pre dose | NA nanogram per milliliter | — |
| Phase 2: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 4 Day 15: pre dose | NA nanogram per milliliter | — |
| Phase 2: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 3 Day 15: pre dose | NA nanogram per milliliter | — |
| Phase 2: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 1 Day 1: 1.5 Hours post dose | 261 nanogram per milliliter | Geometric Coefficient of Variation 90.9 |
| Phase 2: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 2 Day 15: pre dose | 88.5 nanogram per milliliter | Geometric Coefficient of Variation 111.3 |
| Phase 2: Nivolumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 1 Day 15: 1.5 Hours post dose | 294 nanogram per milliliter | Geometric Coefficient of Variation 84.4 |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 1 Day 1: 1.5 Hours post dose | 217 nanogram per milliliter | Geometric Coefficient of Variation 134.5 |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 2 Day 15: pre dose | 120 nanogram per milliliter | Geometric Coefficient of Variation 77.7 |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 3 Day 15: pre dose | 89.2 nanogram per milliliter | Geometric Coefficient of Variation 183.4 |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 1 Day 15: pre dose | 81.8 nanogram per milliliter | Geometric Coefficient of Variation 143.6 |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 5 Day 15: pre dose | NA nanogram per milliliter | — |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 4 Day 15: pre dose | NA nanogram per milliliter | — |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Concentration Versus Time Summary of Plasma Concentration of Binimetinib | Cycle 1 Day 15: 1.5 Hours post dose | 324 nanogram per milliliter | Geometric Coefficient of Variation 83.3 |
Duration of Response (DOR) as Per RECIST v1.1
DOR was defined as the time between the date of the first documented confirmed response (PR or CR) and the date of the first documented progression or death due to any cause. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures \<10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters. PD was defined as at least 20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
Time frame: From date of first documented CR/PR to date of first documented PD, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately, Phase 2: maximum up to 26 months approximately)
Population: FAS included all participants who received at least 1 dose of any study drug in Phase 1b and all participants randomized to study treatment in Phase 2. Here, Overall Number of Participants Analyzed signifies number of participants who achieved an objective response. There were no participants who had event in Phase 1b and Nivolumab and Binimetinib group of Phase 2.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Duration of Response (DOR) as Per RECIST v1.1 | 11.4 Months |
Number of Participants With Abnormal Hepatic Laboratory Values
Criteria for abnormal hepatic laboratory parameters: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT): \>3\* upper limit of normal (ULN), \>5\*ULN, \>8\*ULN, \>10\*ULN, \>20\*ULN; Total bilirubin (TBL) \>1.5\*ULN, \>2\*ULN; Alkaline phosphatase (ALP) \>2\*ULN, \>3\*ULN. Categories with at least 1 non-zero data values are reported.
Time frame: Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately)
Population: Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | Total bilirubin: >1.5 ULN | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | Alkaline phosphatase: >3 ULN | 4 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT or AST: >5 ULN | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT: >3 ULN | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT or AST: >8 ULN | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT: >8 ULN | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | AST: >3 ULN | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT: >5 ULN | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | Alkaline phosphatase: >2 ULN | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | AST: >5 ULN | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | AST: >8 ULN | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT or AST: >3 ULN | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT: >5 ULN | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT or AST: >3 ULN | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | AST: >3 ULN | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT or AST: >8 ULN | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | Total bilirubin: >1.5 ULN | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT or AST: >5 ULN | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT: >3 ULN | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | AST: >8 ULN | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | AST: >5 ULN | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT: >8 ULN | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | Alkaline phosphatase: >3 ULN | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | Alkaline phosphatase: >2 ULN | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT or AST: >5 ULN | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT: >3 ULN | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT: >5 ULN | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT: >8 ULN | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | AST: >3 ULN | 4 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | AST: >5 ULN | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | AST: >8 ULN | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT or AST: >3 ULN | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT or AST: >8 ULN | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | Total bilirubin: >1.5 ULN | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | Alkaline phosphatase: >2 ULN | 4 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | Alkaline phosphatase: >3 ULN | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | AST: >8 ULN | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | AST: >5 ULN | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT: >3 ULN | 7 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | Total bilirubin: >1.5 ULN | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | AST: >3 ULN | 8 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT: >8 ULN | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | Alkaline phosphatase: >3 ULN | 4 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | Alkaline phosphatase: >2 ULN | 8 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT or AST: >5 ULN | 4 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT or AST: >3 ULN | 7 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT: >5 ULN | 5 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Abnormal Hepatic Laboratory Values | ALT or AST: >8 ULN | 1 Participants |
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation
Hematological parameters included: Hemoglobin graded high, Hemoglobin graded low, Platelets count graded low, White Blood Cell (WBC) graded high, WBC graded low, Neutrophils graded low, Lymphocytes graded high, Lymphocytes graded low. Coagulation parameters included: International Normalized Ratio (INR) graded high, Activated Partial Thromboplastin Time (aPTT) graded high. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. A grade 0 was assigned for all non-missing values not graded as 1 or higher. If value was graded \>=1 but falls within the normal range, the grade was reset to 0. Categories with at least 1 non-zero data values are reported.
Time frame: Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately)
Population: Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 3 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 8 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 2 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 2 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 2 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 3 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 3 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 9 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 9 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 1 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 9 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 10 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 6 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes - CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 6 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 10 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 3 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 1 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 8 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 2 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 11 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 11 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 11 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 11 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 9 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 1 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 11 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 3 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes - CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 3 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 6 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 3 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 25 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 23 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 21 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 2 (at baseline) to Grade 2 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 2 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 26 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes - CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 11 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 2 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 2 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 2 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 3 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 21 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 4 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 3 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 26 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 16 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 1 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 16 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 1 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Missing (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes - CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 11 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 27 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 26 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 2 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 1 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 17 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 2 (at baseline) to Grade 2 (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Neutrophils- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 26 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 26 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 8 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Grade 1 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | aPTT- CTCAE Graded High: Missing (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 10 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 2 (at baseline) to Grade 3 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Hemoglobin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 24 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 2 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 2 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | INR- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 13 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | WBC- CTCAE Graded Low: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Lymphocytes- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Hematology and Coagulation | Platelets- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 22 Participants |
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry
Abnormalities: Albumin graded low, Alkaline phosphatase (ALP) graded high, Alanine aminotransferase (ALT) graded high, Aspartate aminotransferase (AST) graded high, Bilirubin graded high, Amylase graded high, Creatinine graded high, Corrected calcium graded high, Creatine Kinase (CK) graded high, Glucose graded high, Glucose graded low, Lipase graded high, Magnesium graded high, Magnesium graded low, Potassium graded high, Potassium graded low, Sodium graded high and Sodium graded low. Test abnormalities were graded by CTCAE v4.03 as Grade 1=mild; Grade 2=moderate; Grade 3/Grade 4=severe/life-threatening. A grade 0 was assigned for all non-missing values not graded as 1 or higher. If value was graded \>=1 but falls within the normal range, the grade was reset to 0. Categories with at least 1 non-zero data values are reported.
Time frame: Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately)
Population: Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 9 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose - CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 2 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 2 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 3 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 10 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 8 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Missing (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 1 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 10 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 9 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 8 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Missing (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 2 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 10 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 10 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 2 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 10 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Missing (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 1 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 6 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Missing (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Missing (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 10 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Missing (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose - CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 6 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 11 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 10 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 2 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 3 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 9 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 2 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 2 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 3 (at baseline) to Grade 3 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 11 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 3 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 9 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 10 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 11 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 11 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 12 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 7 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 2 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 2 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 3 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 8 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 11 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 2 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 8 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 9 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 7 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 7 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 8 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 2 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 2 (at baseline) to Grade 3 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 3 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 3 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 18 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 25 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 4 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 24 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 25 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 11 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 4 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 14 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 4 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 23 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 18 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose - CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose - CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 3 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 3 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 3 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Missing (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Missing (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Missing (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 17 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 22 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 2 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 26 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 20 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 4 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 3 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 23 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 19 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 4 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 1 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 23 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 13 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 8 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 7 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 7 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 4 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 22 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 23 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 25 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 2 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 4 (at baseline) to Grade 4 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 2 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 24 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Bilirubin- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 24 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 2 (at baseline) to Grade 4 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 12 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Amylase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 20 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 3 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 3 (at baseline) to Grade 3 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Corrected Calcium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 25 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 27 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 2 (at baseline) to Grade 3 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 2 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Magnesium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 7 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 23 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 4 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 11 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Sodium- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 14 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 1 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 1 (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Albumin- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 8 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose - CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 1 (at baseline) to Grade 0 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 23 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose - CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 3 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 1 (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 3 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Grade 3 (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Grade 1 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded Low: Grade 0 (at baseline) to Grade 0 (at post baseline) | 26 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Missing (at baseline) to Grade 0 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase - CTCAE Graded High: Missing (at baseline) to Grade 1 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 3 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Missing (at baseline) to Grade 3 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 4 (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | AST- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Glucose- CTCAE Graded High: Missing (at baseline) to Missing (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 18 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatinine- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 7 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | ALT- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 0 (at post baseline) | 15 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 1 (at baseline) to Grade 4 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 1 (at baseline) to Grade 3 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Potassium- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 1 (at baseline) to Grade 2 (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Creatine kinase- CTCAE Graded High: Grade 0 (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Alkaline phosphatase- CTCAE Graded High: Grade 0 (at baseline) to Grade 1 (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on CTCAE v4.03: Chemistry | Lipase- CTCAE Graded High: Grade 0 (at baseline) to Grade 2 (at post baseline) | 0 Participants |
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function
Chemistry laboratory parameters: Blood urea nitrogen (BUN), Total protein, Chloride, Cancer antigen 19-9 (CA 19-9), Brain natriuretic peptide (BNP), Bicarbonate, Direct bilirubin, Carcinoembryonic antigen (CEA), Lactate dehydrogenase (LDH), Uric acid, Troponin I. Thyroid panel laboratory parameters: Thyroid-stimulating hormone (TSH), Free triiodothyronine (T3), Free thyroxine (T4). Laboratory values were as per laboratory normal ranges. Values above range were reported as high and values below range as low. Shift in chemistry and thyroid panel severity from baseline grade low, normal, high and missing to the post baseline grades as low, normal, high and missing are reported in this outcome measure. Categories with at least 1 non-zero data values are reported.
Time frame: Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately)
Population: Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to Low (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: High (at baseline) to High (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: High (at baseline) to High (at post baseline) | 9 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: Normal (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to Low (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: High (at baseline) to High (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to Normal (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Missing (at baseline) to Normal (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: Normal (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to Normal (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to Low (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: High (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: High (at baseline) to High (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: Normal (at baseline) to Normal (at post baseline) | 8 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Missing (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: Normal (at baseline) to High (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: Normal (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Normal (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to Normal (at post baseline) | 10 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: High (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: Normal (at baseline) to Normal (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to Normal (at post baseline) | 8 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN (mmol/L): Normal (at baseline) to High (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to Normal (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to Low (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Normal (at baseline) to Normal (at post baseline) | 8 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to High & Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: High (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to Normal (at post baseline) | 8 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Low (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Missing (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Low (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Low (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Low (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Normal (at baseline) to Low (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Normal (at baseline) to Normal (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Normal (at baseline) to High (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: High (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: Normal (at baseline) to Normal (at post baseline) | 6 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: Normal (at baseline) to High (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: High (at baseline) to Normal (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: High (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: Normal (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN (mmol/L): Normal (at baseline) to High (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: High (at baseline) to High (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Low (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to Normal (at post baseline) | 6 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to High (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: Normal (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: High (at baseline) to High (at post baseline) | 6 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: High (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: High (at baseline) to High (at post baseline) | 9 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: High (at baseline) to Missing (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Low (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to Low (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to Normal (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to High & Low (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to Low (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to Normal (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Low (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Low (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to Normal (at post baseline) | 8 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: Normal (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: Normal (at baseline) to High (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: High (at baseline) to High (at post baseline) | 6 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to Low (at post baseline) | 6 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to Normal (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to Normal (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: High (at baseline) to Normal (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: High (at baseline) to High (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: High (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Normal (at baseline) to Normal (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Missing (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: High (at baseline) to Missing (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Low (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to Low (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to Low (at post baseline) | 8 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: High (at baseline) to Normal (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to Normal (at post baseline) | 15 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Normal (at baseline) to Low (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Normal (at baseline) to Missing (at post baseline) | 14 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to High & Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Low (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Low (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to Normal (at post baseline) | 14 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to Low (at post baseline) | 8 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN (mmol/L): Normal (at baseline) to High (at post baseline) | 9 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to Normal (at post baseline) | 15 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to High and Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: Normal (at baseline) to Normal (at post baseline) | 15 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Normal (at baseline) to Normal (at post baseline) | 11 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to Missing (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to High (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Low (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to Low (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to Normal (at post baseline) | 17 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to High and Low (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to High (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to High and Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to Missing (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: Normal (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: Normal (at baseline) to Normal (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: Normal (at baseline) to Normal (at post baseline) | 24 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to Missing (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: Normal (at baseline) to High (at post baseline) | 14 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: High (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Low (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: High (at baseline) to High (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: High (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: High (at baseline) to Normal (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to Low (at post baseline) | 11 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to Normal (at post baseline) | 12 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Normal (at baseline) to High (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: High (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: Normal (at baseline) to Normal (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Low (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: Normal (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to Normal (at post baseline) | 18 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to High and Low (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to Low (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Normal (at baseline) to Normal (at post baseline) | 15 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: High (at baseline) to High (at post baseline) | 16 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: High (at baseline) to Missing (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Low (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: Normal (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: Normal (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Low (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: High (at baseline) to High (at post baseline) | 20 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: High (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to Normal (at post baseline) | 11 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: Normal (at baseline) to Normal (at post baseline) | 5 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: Normal (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: Normal (at baseline) to High (at post baseline) | 10 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Normal (at baseline) to Low (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: High (at baseline) to High (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to Missing (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Missing (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Low (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: High (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: High (at baseline) to High (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to Low (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: Normal (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to Low (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to Normal (at post baseline) | 22 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: High (at baseline) to High (at post baseline) | 11 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to Low (at post baseline) | 9 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | LDH: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Chloride: Normal (at baseline) to High & Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Low (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Low (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN (mmol/L): Normal (at baseline) to High (at post baseline) | 7 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Low (at baseline) to Low (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to Low (at post baseline) | 7 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to Low (at post baseline) | 11 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to Normal (at post baseline) | 20 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to Normal (at post baseline) | 15 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BUN: Normal (at baseline) to Normal (at post baseline) | 14 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Low (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Normal (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to Normal (at post baseline) | 14 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T3: High (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: High (at baseline) to High (at post baseline) | 16 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Low (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: High (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Low (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Missing (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to Low (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Normal (at baseline) to Normal (at post baseline) | 10 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to High and Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to Normal (at post baseline) | 17 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to High (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Protein: Normal (at baseline) to High (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: High (at baseline) to High (at post baseline) | 20 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | TSH: Normal (at baseline) to High and Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Bicarbonate: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to High and Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: Normal (at baseline) to High (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Low (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: High (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: Normal (at baseline) to Missing (at post baseline) | 2 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Uric acid: Normal (at baseline) to Normal (at post baseline) | 16 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: High (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CEA: High (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Free T4: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | CA 19-9: Normal (at baseline) to Normal (at post baseline) | 7 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | BNP: Normal (at baseline) to Normal (at post baseline) | 22 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Chemistry and Thyroid Function | Troponin I: Normal (at baseline) to Missing (at post baseline) | 14 Participants |
Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation
Hematology parameters: Basophils, Eosinophils, Hematocrit, Monocytes, Red blood cells (RBC). Coagulation parameters: Prothrombin Time. Laboratory values were as per laboratory normal ranges. Values above range were reported as high and values below range as low. Laboratory parameters were graded based on laboratory normal ranges as low, normal, high and missing are reported in this outcome measure. Categories with at least 1 non-zero data values are reported.
Time frame: Phase 1b: Baseline up to 30 days after last dose (maximum up to 9 months approximately), Phase 2: Baseline up to 30 days after last dose (maximum up to 26 months approximately)
Population: Safety set included of all participants who received at least 1 dose of study drug. Here Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: High (at baseline) to High (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to Normal (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to Normal (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Low (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to Low (at post baseline) | 6 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to High (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Basophils: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Low (at baseline) to Low (at post baseline) | 2 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Basophils: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Low (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: Normal (at baseline) to High (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Low (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Normal (at baseline) to Low (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: Normal (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Normal (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Normal (at baseline) to High & Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: High (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Basophils: Normal (at baseline) to Normal (at post baseline) | 10 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to Normal (at post baseline) | 9 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to High (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: Normal (at baseline) to High (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to Normal (at post baseline) | 11 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Normal (at baseline) to Normal (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to Normal (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Low (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Basophils: Normal (at baseline) to Normal (at post baseline) | 11 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Basophils: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to Normal (at post baseline) | 7 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Low (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to Low (at post baseline) | 5 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Low (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Basophils: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: Normal (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Normal (at baseline) to Low (at post baseline) | 4 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: High (at baseline) to High (at post baseline) | 3 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Normal (at baseline) to High & Low (at post baseline) | 1 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Low (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: Normal (at baseline) to High (at post baseline) | 11 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Basophils: Normal (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Basophils: Normal (at baseline) to Normal (at post baseline) | 25 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Basophils: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to Normal (at post baseline) | 25 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Low (at baseline) to Low (at post baseline) | 8 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Low (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Low (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Normal (at baseline) to Low (at post baseline) | 13 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Normal (at baseline) to Normal (at post baseline) | 4 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Normal (at baseline) to High & Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to Normal (at post baseline) | 19 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to High (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Low (at baseline) to Low (at post baseline) | 13 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Low (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to Low (at post baseline) | 8 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to Normal (at post baseline) | 3 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: Normal (at baseline) to Normal (at post baseline) | 8 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: High (at baseline) to High (at post baseline) | 7 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: High (at baseline) to Missing (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to High (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: High (at baseline) to High (at post baseline) | 9 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to High (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to Normal (at post baseline) | 20 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Basophils: Normal (at baseline) to Normal (at post baseline) | 27 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Normal (at baseline) to High & Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: High (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Normal (at baseline) to Normal (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Normal (at baseline) to Low (at post baseline) | 12 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Low (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Basophils: Normal (at baseline) to Low (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: Normal (at baseline) to Normal (at post baseline) | 8 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Low (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Hematocrit: Low (at baseline) to Low (at post baseline) | 9 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: Normal (at baseline) to High (at post baseline) | 9 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to High (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to Normal (at post baseline) | 20 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: Missing (at baseline) to High (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: High (at baseline) to Normal (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Eosinophils: Normal (at baseline) to Low (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Low (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Basophils: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to Low (at post baseline) | 10 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Low (at baseline) to Low (at post baseline) | 6 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: High (at baseline) to Normal (at post baseline) | 1 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Prothrombin Time: High (at baseline) to Missing (at post baseline) | 0 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | RBC: Normal (at baseline) to Normal (at post baseline) | 9 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Shift From Baseline in Laboratory Parameter Values Based on Normal Range: Hematology and Coagulation | Monocytes: Normal (at baseline) to Missing (at post baseline) | 0 Participants |
Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes/deemed significant for any other reason: death; initial /prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs: events between first dose of study drug and up to 30 days after last dose or before start of new anticancer therapy minus 1 day, whichever occurred first. TEAE graded by CTCAE grade 4.03: Grade 3: severe/medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care activities of daily living (ADL); Grade 4: life-threatening consequence, urgent intervention indicated. In this outcome measure, number of participants with 'all grades' and 'Grade 3/4' were reported.
Time frame: From start of the treatment up to 30 days after last dose or start of new anticancer therapy minus 1 day, whichever occurred first (Phase 1b: maximum up to 9 months approximately and Phase 2: maximum up to 26 months approximately)
Population: The safety set included of all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent AEs- All grades | 10 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent SAEs- All grades | 5 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent AEs- Grade 3/4 | 6 Participants |
| Phase 1b: Nivolumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent SAEs- Grade 3/4 | 5 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent SAEs- All grades | 6 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent AEs- Grade 3/4 | 8 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent SAEs- Grade 3/4 | 6 Participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent AEs- All grades | 11 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent AEs- Grade 3/4 | 19 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent SAEs- All grades | 12 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent SAEs- Grade 3/4 | 11 Participants |
| Phase 2: Nivolumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent AEs- All grades | 27 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent SAEs- Grade 3/4 | 10 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent SAEs- All grades | 11 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent AEs- All grades | 27 Participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Based on Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Treatment emergent AEs- Grade 3/4 | 21 Participants |
Percentage of Participants With Complete Response as Per RECIST v1.1
Complete response as per RECIST v1.1 was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm.
Time frame: From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately and Phase 2: maximum up to 26 months approximately)
Population: FAS included all participants who received at least 1 dose of any study drug in Phase 1b and all participants randomized to study treatment in Phase 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b: Nivolumab+Binimetinib | Percentage of Participants With Complete Response as Per RECIST v1.1 | 0 Percentage of participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Percentage of Participants With Complete Response as Per RECIST v1.1 | 0 Percentage of participants |
| Phase 2: Nivolumab+Binimetinib | Percentage of Participants With Complete Response as Per RECIST v1.1 | 0 Percentage of participants |
| Phase 2: Nivolumab+Ipilimumab+Binimetinib | Percentage of Participants With Complete Response as Per RECIST v1.1 | 0 Percentage of participants |
Phase 1b: Objective Response Rate (ORR) Per RECIST v1.1
ORR was defined as the percentage of participants who achieved a BOR of CR or PR as determined by investigator per RECIST v1.1. As per RECIST v1.1, CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non-target lesions must be non-PD. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Time frame: From start of the treatment until disease progression, death or initiation of new anticancer therapy, whichever occurred first (Phase 1b: maximum up to 9 months approximately)
Population: All participants who received at least 1 dose of any study treatment in Phase 1b.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b: Nivolumab+Binimetinib | Phase 1b: Objective Response Rate (ORR) Per RECIST v1.1 | 0.0 Percentage of participants |
| Phase 1b: Nivolumab+Ipilimumab+Binimetinib | Phase 1b: Objective Response Rate (ORR) Per RECIST v1.1 | 0.0 Percentage of participants |