Carcinoma, Non-Small- Cell Lung, Melanoma
Conditions
Keywords
Relapsed melanoma, Refractory melanoma, Metastatic uveal melanoma, Metastatic PD-(L)1-naïve melanoma, Non-squamous NSCLC, NSCLC, Non-small cell lung cancer, Seattle Genetics
Brief summary
This trial is being done to see if an experimental drug (SEA-CD40) works when it's given with other cancer drugs to treat some types of cancer. It will also study side effects from the drug. There are 2 parts in this trial. In one part, participants have melanoma that has come back after treatment or can't be removed by surgery. Participants in this part will get SEA-CD40 and pembrolizumab. In the other part, participants have non-small cell lung cancer (NSCLC) that has spread through their body. These participants will get SEA-CD40, pembrolizumab, carboplatin, and pemetrexed.
Interventions
DRUGSEA-CD40
Given into the vein (IV; intravenously); schedule is cohort-specific
DRUGpembrolizumab (KEYTRUDA®)
Given by IV; schedule is cohort-specific.
DRUGpemetrexed
Given by IV on Day 1 of each 21-day cycle.
DRUGcarboplatin
Given by IV on Day 1 of Cycles 1-4. Each cycle will be 21 days long.
Sponsors
Merck Sharp & Dohme LLC
Seagen Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed unresectable malignancy defined as one of the following: * Cohort 1: Relapsed and/or refractory metastatic melanoma * Uveal/ocular melanoma is excluded * Must have progressed on treatment with an anti-PD-(L)1 mAb. PD-(L)1 treatment progression is defined as meeting all of the following criteria: * Has received at least 2 doses of an approved anti-PD-(L)1 mAb * Has demonstrated disease progression after PD-(L)1 as defined by RECIST v1.1. * Progressive disease has been documented within 12 weeks from the last dose of anti- PD-(L)1 mAb * Last dose of anti-PD-(L)1 must have been within 90 days prior to enrollment * Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or declined treatment with BRAF/MEK targeted therapy prior to study entry * Cohort 2: Metastatic uveal melanoma * Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy * No prior liver-directed therapy * Cohort 3: Metastatic PD-(L)1-naive melanoma * Uveal/ocular melanoma is excluded * Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy. * For participants with a targetable BRAF mutation, prior BRAF/MEK targeted therapy is allowed if completed 4 weeks prior to first dose of study treatment. * Cohorts 4 and 5: Non-squamous NSCLC * Participants must have stage IV disease per AJCC 8th edition * No known driver mutations/alterations mutation for which targeted therapy is available * Must have non-squamous histology. * No prior therapy for metastatic disease * No prior treatment with anti-PD-(L)1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms * Able to provide archival tumor tissue from locations not radiated prior to biopsy. If archival tumor sample is not available a fresh baseline biopsy is required. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Measurable disease per RECIST v1.1 at baseline
Exclusion criteria
* History of another malignancy within 3 years of first dose of study drug * Active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Previous exposure to CD40-targeted therapy * Currently on chronic systemic steroids in excess of physiologic replacement * Has had an allogeneic tissue/solid organ transplant. * History of autoimmune disease that has required systemic treatment in the past 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator Assessment | From start of study treatment until CR or PR (maximum up to 15.2 months) | cORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Baseline up to approximately 15.8 months | In this outcome measure, number of participants with baseline laboratory chemistry values as per NCI-CTCAE grade (grade 0=within normal limits, grade 1=mild, grade 2=moderate, grade 3=severe, grade 4= life-threatening) and corresponding changes or shift to the worst CTC grades post baseline were presented. Laboratory parameters evaluated: alanine aminotransferase increased, albumin decreased, alkaline phosphatase increased, aspartate aminotransferase increased, calcium corrected for albumin, creatinine increased, glomerular filtration rate (GFR) estimated decreased, glucose decreased, lactate dehydrogenase increased, potassium, sodium, total bilirubin increased. Baseline was defined as last non-missing grade before first dose of study treatment and worst post-baseline value defined as worst value post study treatment. Only those categories in which at least 1 participant had data in any reporting group were reported. |
| Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Baseline up to approximately 15.8 months | In this outcome measure, number of participants with baseline laboratory hematology values as per NCI-CTCAE grade (grade 0= within normal limits, grade 1=mild, grade 2=moderate, grade 3= severe, grade 4= life-threatening) and corresponding changes or shift to the worst CTC grades post baseline were presented. Laboratory parameters evaluated: hemoglobin- decreased and increased, leukocytes- decreased and increased, lymphocytes- decreased and increased, neutrophils decreased, platelets decreased. Baseline was defined as last non-missing grade before first dose of study treatment and worst post-baseline value defined as worst value post study treatment. Only those categories in which at least 1 participant had data in any reporting group were reported. |
| Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | From first dose of the study treatment (Day 1) up to approximately 18.5 months | An AE is defined as any untoward medical occurrence in participant/clinical investigational participant administered medicinal product which doesn't necessarily have causal relationship with treatment. Number of participants with dose interruption (SEA-CD40 treatment being temporarily stopped), dose reduction (SEA-CD40 decrease in dose) and dose discontinuation (SEA-CD40 treatment permanently stopped) due to adverse events were reported in this outcome measure. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | From first dose of the study treatment (Day 1) up to approximately 18.5 months | Adverse event (AE):untoward medical occurrence in participant/clinical investigational participant administered medicinal product which doesn't necessarily have causal relationship with treatment. Serious AE (SAE):any AE that at any dose resulted in death, life threatening, required hospitalization/prolongation of hospitalization, disabling/incapacitating, congenital anomaly/birth defects.AEs included SAEs,non-SAEs.TEAEs:newly occurring/worsening after 1st dose of treatment.Treatment related TEAEs:related to treatment;relatedness judged by investigator. TEAEs graded according to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) v4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threating, grade 5=fatal). TESAEs:any TEAE that at any dose suspected to cause death, life-threatening, required hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Treatment related TESAEs:related to treatment; relatedness judged by investigator. |
| Duration of Response (DOR) Per Investigator Assessment | From the first documentation of CR or PR to PD or death due to any cause or censoring, whichever occurred first (maximum up to 11.1 months) | DOR: time from first documentation of OR (confirmed CR or PR) to first documentation of PD or death due to any cause, whichever occurred first. Per RECIST v1.1- CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: \>=30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Participants with no PD and were still on study at time of analysis or were removed from study prior to documentation of PD were censored at last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must demonstrate absolute increase of 0.5 cm. Appearance of 1 or more new lesions. Kaplan-Meier method was used. |
| Progression Free Survival (PFS) Per Investigator Assessment | From first dose of study treatment to the date of PD or death due to any cause or censoring, whichever occurred first (maximum up to 13.9 months) | PFS is defined as time from start of study treatment to first documentation of PD by RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PD and were still on study at time of analysis or who were removed from study prior to documentation of PD were censored at the date of last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at date of last disease assessment prior to start of new treatment. PD: At least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that is the smallest on study). In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions was also considered progression. Kaplan-Meier method was used. |
| Overall Survival (OS) | From start of study treatment to death due to any cause or censoring date (maximum up to 23.6 months) | OS is defined as the time from the start of study treatment to date of death due to any cause. In the absence of death, survival time was censored at the last date the participant was known to be alive. Kaplan-Meier method was used for analysis. |
| Disease Control Rate (DCR) Per Investigator Assessment | From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 15.2 months) | DCR is defined as the percentage of participants who achieved a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator or met the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 5 weeks. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase in lesions to qualify for progressive disease (PD) referring smallest sum diameter, PD: at least 20% increase (including absolute increase of at least 5 mm) in sum of diameters of target lesions, taking reference smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. |
Countries
Canada, France, Germany, Spain, Sweden, United States
Participant flow
Recruitment details
This study planned to have 5 cohorts-Cohort 1: relapsed/refractory melanoma, Cohort 2: uveal melanoma, Cohort 3: programmed cell death 1 ligand 1 (PD-\[L\]1)-naive melanoma, Cohort 4: non-small cell lung cancer (NSCLC), programmed cell death ligand 1 (PD-L1) 1-49%, Cohort 5: NSCLC, PD-L1 \< 1%. No participant was enrolled and treated in Cohort 3.
Pre-assignment details
Study termination by sponsor was used as end of study reason as long-term follow-up was discontinued following decision to close enrollment. Study status is listed completed as participants were permitted to receive treatment until they met protocol defined reasons to stop. After treatment discontinuation, participants were followed through duration of safety reporting period, and then ended study as no further disease or survival follow-up was required.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Relapsed/Refractory Melanoma Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles. | 21 |
| Cohort 2: Uveal Melanoma Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles. | 39 |
| Cohort 4: NSCLC, PD-L1 1-49% Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). | 9 |
| Cohort 5: NSCLC, PD-L1 < 1% Participants with NSCLC, PD-L1 \<1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m\^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). | 8 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 11 | 8 | 3 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Other | 2 | 3 | 3 | 2 |
| Overall Study | Study termination by sponsor | 3 | 25 | 3 | 3 |
| Overall Study | Subject withdrawal of consent | 4 | 3 | 0 | 2 |
Baseline characteristics
| Characteristic | Cohort 1: Relapsed/Refractory Melanoma | Cohort 2: Uveal Melanoma | Cohort 4: NSCLC, PD-L1 1-49% | Cohort 5: NSCLC, PD-L1 < 1% | Total |
|---|---|---|---|---|---|
| Age, Continuous | 64.3 Years STANDARD_DEVIATION 11.6 | 62.3 Years STANDARD_DEVIATION 12.4 | 64.6 Years STANDARD_DEVIATION 9.2 | 66.8 Years STANDARD_DEVIATION 9.5 | 63.6 Years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 38 Participants | 9 Participants | 5 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 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 | 4 Participants | 0 Participants | 0 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 16 Participants | 39 Participants | 9 Participants | 5 Participants | 69 Participants |
| Sex: Female, Male Female | 9 Participants | 20 Participants | 4 Participants | 2 Participants | 35 Participants |
| Sex: Female, Male Male | 12 Participants | 19 Participants | 5 Participants | 6 Participants | 42 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 | 11 / 21 | 8 / 39 | 3 / 9 | 1 / 8 |
| other Total, other adverse events | 17 / 21 | 37 / 39 | 8 / 9 | 7 / 8 |
| serious Total, serious adverse events | 4 / 21 | 5 / 39 | 5 / 9 | 5 / 8 |
Outcome results
Primary
Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator Assessment
cORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions.
Time frame: From start of study treatment until CR or PR (maximum up to 15.2 months)
Population: The response evaluable (RE) analysis set included all participants with measurable disease at baseline who received any amount of study drug and had at least one post-baseline disease assessment per RECIST v1.1 or discontinued study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Melanoma | Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator Assessment | 0 Percentage of participants |
| Cohort 2: Uveal Melanoma | Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator Assessment | 5 Percentage of participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator Assessment | 44 Percentage of participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator Assessment | 25 Percentage of participants |
Secondary
Disease Control Rate (DCR) Per Investigator Assessment
DCR is defined as the percentage of participants who achieved a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator or met the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 5 weeks. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (\<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase in lesions to qualify for progressive disease (PD) referring smallest sum diameter, PD: at least 20% increase (including absolute increase of at least 5 mm) in sum of diameters of target lesions, taking reference smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Time frame: From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 15.2 months)
Population: The RE analysis set included all participants with measurable disease at baseline who received any amount of study drug and had at least one post-baseline disease assessment per RECIST v1.1 or discontinued study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Melanoma | Disease Control Rate (DCR) Per Investigator Assessment | 48 Percentage of participants |
| Cohort 2: Uveal Melanoma | Disease Control Rate (DCR) Per Investigator Assessment | 62 Percentage of participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Disease Control Rate (DCR) Per Investigator Assessment | 67 Percentage of participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Disease Control Rate (DCR) Per Investigator Assessment | 88 Percentage of participants |
Secondary
Duration of Response (DOR) Per Investigator Assessment
DOR: time from first documentation of OR (confirmed CR or PR) to first documentation of PD or death due to any cause, whichever occurred first. Per RECIST v1.1- CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: \>=30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Participants with no PD and were still on study at time of analysis or were removed from study prior to documentation of PD were censored at last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must demonstrate absolute increase of 0.5 cm. Appearance of 1 or more new lesions. Kaplan-Meier method was used.
Time frame: From the first documentation of CR or PR to PD or death due to any cause or censoring, whichever occurred first (maximum up to 11.1 months)
Population: The RE analysis set included all participants with measurable disease at baseline who received any amount of study drug and had at least one post-baseline disease assessment per RECIST v1.1 or discontinued study treatment. Here, ''Overall Number of Participants Analyzed'' signifies participants with confirmed CR or PR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 2: Uveal Melanoma | Duration of Response (DOR) Per Investigator Assessment | NA Months |
| Cohort 4: NSCLC, PD-L1 1-49% | Duration of Response (DOR) Per Investigator Assessment | 11.1 Months |
| Cohort 5: NSCLC, PD-L1 < 1% | Duration of Response (DOR) Per Investigator Assessment | 2.1 Months |
Secondary
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE
In this outcome measure, number of participants with baseline laboratory hematology values as per NCI-CTCAE grade (grade 0= within normal limits, grade 1=mild, grade 2=moderate, grade 3= severe, grade 4= life-threatening) and corresponding changes or shift to the worst CTC grades post baseline were presented. Laboratory parameters evaluated: hemoglobin- decreased and increased, leukocytes- decreased and increased, lymphocytes- decreased and increased, neutrophils decreased, platelets decreased. Baseline was defined as last non-missing grade before first dose of study treatment and worst post-baseline value defined as worst value post study treatment. Only those categories in which at least 1 participant had data in any reporting group were reported.
Time frame: Baseline up to approximately 15.8 months
Population: The safety analysis set included all participants who received any amount of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 3 to maximum post-baseline Grade 4 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 3 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Platelets - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 2 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 1 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 7 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 4 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to post-baseline Grade 3 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 4 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 1 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 2 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 1 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 2 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 4 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 3 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 9 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 11 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 2 to maximum post-baseline Grade 3 | 2 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 3 to maximum post-baseline Grade 4 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 1 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to post-baseline Grade 3 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Platelets - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 1 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 1 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 3 to maximum post-baseline Grade 4 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 4 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 2 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 4 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to post-baseline Grade 3 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 2 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 2 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 2 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 2 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Platelets - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 4 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Platelets - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 3 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 1 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 3 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 2 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 4 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Leukocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to post-baseline Grade 3 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 0 to maximum post-baseline Grade 4 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 1 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 2 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - decreased: baseline Grade 3 to maximum post-baseline Grade 4 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Lymphocytes - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Neutrophils - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | Hemoglobin - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
Secondary
Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE
In this outcome measure, number of participants with baseline laboratory chemistry values as per NCI-CTCAE grade (grade 0=within normal limits, grade 1=mild, grade 2=moderate, grade 3=severe, grade 4= life-threatening) and corresponding changes or shift to the worst CTC grades post baseline were presented. Laboratory parameters evaluated: alanine aminotransferase increased, albumin decreased, alkaline phosphatase increased, aspartate aminotransferase increased, calcium corrected for albumin, creatinine increased, glomerular filtration rate (GFR) estimated decreased, glucose decreased, lactate dehydrogenase increased, potassium, sodium, total bilirubin increased. Baseline was defined as last non-missing grade before first dose of study treatment and worst post-baseline value defined as worst value post study treatment. Only those categories in which at least 1 participant had data in any reporting group were reported.
Time frame: Baseline up to approximately 15.8 months
Population: The safety analysis set included all participants who received any amount of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 2 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 5 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 7 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Total bilirubin - increased: baseline Grade 0 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 5 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Albumin - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 3 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Glucose - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 4 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - decreased: baseline Grade 2 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 3 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Total bilirubin - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 1 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Lactate dehydrogenase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 3 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 2 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Lactate dehydrogenase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 1 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - decreased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 3 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - decreased: baseline Grade 2 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 5 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 9 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 2 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Total bilirubin - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 4 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 7 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 1 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Glucose - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 3 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Total bilirubin - increased: baseline Grade 0 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 10 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Lactate dehydrogenase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 22 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Lactate dehydrogenase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 4 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - decreased: baseline Grade 1 to maximum post-baseline Grade 0 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Albumin - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 14 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 9 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 2 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 3 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 2 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 3 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 2 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 2 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 1 to maximum post-baseline Grade 0 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 4 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 2 to maximum post-baseline Grade 0 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 1 to maximum post-baseline Grade 0 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - decreased: baseline Grade 1 to maximum post-baseline Grade 0 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 3 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 3 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Total bilirubin - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Total bilirubin - increased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 2 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 2 to maximum post-baseline Grade 0 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Albumin - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 3 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 4 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - decreased: baseline Grade 2 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Glucose - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Lactate dehydrogenase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 3 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Lactate dehydrogenase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Total bilirubin - increased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 2 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 4 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 2 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Albumin - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alkaline phosphatase - increased: baseline Grade 2 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Aspartate aminotransferase - increased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - decreased: baseline Grade 0 to maximum post-baseline Grade 2 | 2 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - decreased: baseline Grade 2 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Calcium corrected for albumin - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 0 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Creatinine - increased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Glucose - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 2 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Lactate dehydrogenase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 4 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Lactate dehydrogenase - increased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - decreased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Potassium - increased: baseline Grade 0 to maximum post-baseline Grade 2 | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 1 | 3 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 0 to maximum post-baseline Grade 3 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 1 to maximum post-baseline Grade 0 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Sodium - decreased: baseline Grade 1 to maximum post-baseline Grade 2 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Total bilirubin - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | Alanine aminotransferase - increased: baseline Grade 0 to maximum post-baseline Grade 1 | 3 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE
Adverse event (AE):untoward medical occurrence in participant/clinical investigational participant administered medicinal product which doesn't necessarily have causal relationship with treatment. Serious AE (SAE):any AE that at any dose resulted in death, life threatening, required hospitalization/prolongation of hospitalization, disabling/incapacitating, congenital anomaly/birth defects.AEs included SAEs,non-SAEs.TEAEs:newly occurring/worsening after 1st dose of treatment.Treatment related TEAEs:related to treatment;relatedness judged by investigator. TEAEs graded according to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) v4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threating, grade 5=fatal). TESAEs:any TEAE that at any dose suspected to cause death, life-threatening, required hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Treatment related TESAEs:related to treatment; relatedness judged by investigator.
Time frame: From first dose of the study treatment (Day 1) up to approximately 18.5 months
Population: The safety analysis set included all participants who received any amount of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | Treatment-related TESAE | 2 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | Treatment-related TEAE | 16 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | TESAE | 4 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | TEAE | 17 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | >= Grade 3 TEAEs | 7 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | TEAE | 37 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | Treatment-related TESAE | 2 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | TESAE | 5 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | Treatment-related TEAE | 32 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | >= Grade 3 TEAEs | 7 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | TEAE | 8 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | TESAE | 5 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | >= Grade 3 TEAEs | 7 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | Treatment-related TESAE | 3 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | Treatment-related TEAE | 8 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | Treatment-related TESAE | 3 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | TEAE | 8 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | Treatment-related TEAE | 8 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | TESAE | 5 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | >= Grade 3 TEAEs | 6 Participants |
Secondary
Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events
An AE is defined as any untoward medical occurrence in participant/clinical investigational participant administered medicinal product which doesn't necessarily have causal relationship with treatment. Number of participants with dose interruption (SEA-CD40 treatment being temporarily stopped), dose reduction (SEA-CD40 decrease in dose) and dose discontinuation (SEA-CD40 treatment permanently stopped) due to adverse events were reported in this outcome measure.
Time frame: From first dose of the study treatment (Day 1) up to approximately 18.5 months
Population: The safety analysis set included all participants who received any amount of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | Dose reductions | 0 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | Treatment discontinuations | 2 Participants |
| Cohort 1: Relapsed/Refractory Melanoma | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | Treatment interruptions | 1 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | Dose reductions | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | Treatment discontinuations | 0 Participants |
| Cohort 2: Uveal Melanoma | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | Treatment interruptions | 5 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | Treatment interruptions | 2 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | Treatment discontinuations | 2 Participants |
| Cohort 4: NSCLC, PD-L1 1-49% | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | Dose reductions | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | Dose reductions | 0 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | Treatment discontinuations | 1 Participants |
| Cohort 5: NSCLC, PD-L1 < 1% | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | Treatment interruptions | 1 Participants |
Secondary
Overall Survival (OS)
OS is defined as the time from the start of study treatment to date of death due to any cause. In the absence of death, survival time was censored at the last date the participant was known to be alive. Kaplan-Meier method was used for analysis.
Time frame: From start of study treatment to death due to any cause or censoring date (maximum up to 23.6 months)
Population: The FAS includes all participants who received any amount of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Melanoma | Overall Survival (OS) | 11.0 Months |
| Cohort 2: Uveal Melanoma | Overall Survival (OS) | NA Months |
| Cohort 4: NSCLC, PD-L1 1-49% | Overall Survival (OS) | 18.0 Months |
| Cohort 5: NSCLC, PD-L1 < 1% | Overall Survival (OS) | NA Months |
Secondary
Progression Free Survival (PFS) Per Investigator Assessment
PFS is defined as time from start of study treatment to first documentation of PD by RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PD and were still on study at time of analysis or who were removed from study prior to documentation of PD were censored at the date of last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at date of last disease assessment prior to start of new treatment. PD: At least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that is the smallest on study). In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions was also considered progression. Kaplan-Meier method was used.
Time frame: From first dose of study treatment to the date of PD or death due to any cause or censoring, whichever occurred first (maximum up to 13.9 months)
Population: The full analysis set (FAS) includes all participants who received any amount of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Relapsed/Refractory Melanoma | Progression Free Survival (PFS) Per Investigator Assessment | 1.6 Months |
| Cohort 2: Uveal Melanoma | Progression Free Survival (PFS) Per Investigator Assessment | 4.0 Months |
| Cohort 4: NSCLC, PD-L1 1-49% | Progression Free Survival (PFS) Per Investigator Assessment | 13.8 Months |
| Cohort 5: NSCLC, PD-L1 < 1% | Progression Free Survival (PFS) Per Investigator Assessment | 5.5 Months |