Advanced Cancer
Conditions
Keywords
BMS-986218, Nivolumab, Ipilimumab
Brief summary
The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.
Interventions
BIOLOGICALIpilimumab
Specified dose on specified days
BIOLOGICALBMS-986218
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists * Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A) * Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B & 2C) * Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D)
Exclusion criteria
* Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy * Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
| Number of Participants With Serious Adverse Events (SAEs) | From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months) | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. |
| Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | From first dose of study medication through 60 days following last dose of study treatment (assessed for an average of 7 months up to a max of approximately 27 months) | Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment. Grade 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death Gastrointestinal DLT: * Grade 2 colitis \>5 days * Grade ≥3 diarrhea/colitis Hepatic DLT: * Grade 4 serum transaminases (AST & ALT), alkaline phosphatase (ALP), or total bilirubin elevations * Grade 3 serum AST, ALT, or ALP elevations lasting \>5 days or with clinical symptoms or bilirubin \> 2×ULN without cholestasis Hematologic DLT: * Grade 4 neutropenia ≥7 days * Grade 4 thrombocytopenia Dermatologic DLT: * Grade 4 rash * Grade 3 rash if no improvement after 1-2-week infusion delay Other DLTs: * Grade 2 drug-related uveitis, episcleritis, iritis, eye pain, or blurred vision that doesn't respond to treatment, doesn't improve within the re-treatment period OR requires systemic treatment * Grade 3 drug-related uveitis, episcleritis, iritis, pneumonitis, bronchospasm, or neurologic toxicity |
| Number of Participants With Adverse Events (AEs) Leading to Discontinuation | From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
| Number of Participants Who Died | From randomization (Part 2A and 2B) or first dose (Part 1, 2C and 2D) until study closure (Up to approximately 83 months) | Number of participants who died during the study |
| Objective Response Rate (ORR) for Part 2 Only | From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months) | Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). |
| Median Duration of Response (mDOR) for Part 2 Only | From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months) | Duration of response (DOR) for a participant with a BOR of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1 or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response |
| Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | At 24, 36, and 48 weeks | Progression-free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Based on Kaplan-Meier estimates of progression-free survival rate Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Body Clearance (CLT/F) for BMS-986218 | At Cycle 3 Day 1 (Each Cycle is of 28 Days) | — |
| Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | At Cycle 3 Day 1 (Each Cycle is of 28 Days) | — |
| Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | At Cycle 3 Day 1 (Each Cycle is of 28 Days) | — |
| Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | At Cycle 3 Day 1 (Each Cycle is of 28 Days) | — |
| Time of Maximum Observed Concentration (Tmax) for BMS-986218 | On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days) | Tmax is the time taken to reach the maximum observed serum concentration (Cmax) for BMS-986218. |
| Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | At Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1 (Each Cycle is of 28 Days) | Ctrough is the lowest observed serum concentration for BMS-986218. |
| Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months) | Baseline ADA Positive: Participant with baseline ADA-positive sample ADA Positive: Participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment Persistent Positive (PP): ADA-positive sample at 2 or more consecutive timepoints, where the first and last ADA-positive samples are at least 16weeks apart Not PP-Last Sample Positive: Not persistent but with ADA-positive sample at the last sampling timepoint Other Positive: Not persistent but some ADA-positive samples with the last sample being negative ADA Negative: Participant with no ADA-positive sample after initiation of treatment |
| Terminal Serum Half-life (T-HALF) for BMS-986218 | At Cycle 3 Day 1 (Each Cycle is of 28 Days) | — |
| Objective Response Rate (ORR) for Part1A and Part1B Only | From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months) | Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). |
| Median Duration of Response (mDOR) for Part1A and Part1B Only | From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months) | Duration of response (DOR) for a participant with a BOR of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1 or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response |
| Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | At 24, 36, and 48 weeks | Progression-free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of progression-free survival rate |
| Maximum Observed Serum Concentration (Cmax) for BMS-986218 | On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days) | Cmax is the maximum observed serum concentration for BMS-986218. |
| Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days) | Tmax is the time taken to reach the maximum observed serum concentration (Cmax) for BMS-986218. |
| Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days) | AUC (TAU) is the area measured under the concentration-time curve taken over the dosing interval for BMS-986218. |
| Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days) | Ctau is the observed serum concentration at the end of the dosing interval for BMS-986218. |
Countries
Argentina, Australia, Belgium, Canada, Chile, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Poland, Romania, Spain, Switzerland, United States
Participant flow
Pre-assignment details
Part 1, Part 2C and Part 2D were non-randomized. Part 2A and Part 2B were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors Participants received BMS-986218 at 2 mg every 4 weeks for up to 2 years | 4 |
| Part 1A: BMS-986218 4 mg All Solid Tumors Participants received BMS-986218 at 4 mg every 4 weeks for up to 2 years | 9 |
| Part 1A: BMS-986218 7 mg All Solid Tumors Participants received BMS-986218 at 7 mg every 4 weeks for up to 2 years | 12 |
| Part 1A: BMS-986218 20 mg All Solid Tumors Participants received BMS-986218 at 20 mg every 4 weeks for up to 2 years | 15 |
| Part 1A: BMS-986218 40 mg All Solid Tumors Participants received BMS-986218 at 40 mg every 4 weeks for up to 2 years | 12 |
| Part 1A: BMS-986218 70 mg All Solid Tumors Participants received BMS-986218 at 70 mg every 4 weeks for up to 2 years | 14 |
| Part 1A: BMS-986218 100 mg All Solid Tumors Participants received BMS-986218 at 100 mg every 4 weeks for up to 2 years | 7 |
| Part 1A: BMS-986218 150 mg All Solid Tumors Participants received BMS-986218 at 150 mg every 4 weeks for up to 2 years | 11 |
| Part 1A: BMS-986218 200 mg All Solid Tumors Participants received BMS-986218 at 200 mg every 4 weeks for up to 2 years | 5 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Participants received BMS-986218 at 20 mg every 2 weeks for up to 2 years | 14 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors Participants received BMS-986218 at 35 mg every 2 weeks for up to 2 years | 6 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors Participants received BMS-986218 at 50 mg every 2 weeks for up to 2 years | 4 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort Participants received BMS-986218 at 20 mg every 2 weeks | 1 |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors Participants received BMS-986218 at 7 mg with nivolumab at 480 mg every 4 weeks | 5 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors Participants received BMS-986218 at 20 mg with nivolumab at 480 mg every 4 weeks | 17 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks | 19 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors Participants received BMS-986218 at 70 mg with nivolumab at 480 mg every 4 weeks | 7 |
| Part 2A: Ipilimumab Cutaneous Melanoma Participants received ipilimumab at 3 mg/kg every 3 weeks | 20 |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma Participants received BMS-986218 at 7 mg every 4 weeks | 19 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma Participants received BMS-986218 at 20 mg every 4 weeks | 18 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma Participants received BMS-986218 at 70 mg every 4 weeks | 18 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) Participants received BMS-986218 at 7 mg every 4 weeks | 22 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) Participants received BMS-986218 at 20 mg every 4 weeks | 22 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) Participants received BMS-986218 at 70 mg every 4 weeks | 22 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks | 29 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks | 44 |
| Total | 376 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period | Adverse Event | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 2 | 1 | 4 | 2 | 2 | 2 | 2 | 4 |
| Treatment Period | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period | Disease Progression | 3 | 9 | 8 | 11 | 8 | 4 | 6 | 7 | 2 | 10 | 5 | 2 | 0 | 5 | 14 | 14 | 4 | 3 | 16 | 14 | 12 | 16 | 18 | 13 | 16 | 31 |
| Treatment Period | Other Reasons | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Treatment Period | Participant request to discontinue study treatment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
| Treatment Period | Participants no longer meets study criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Treatment Period | Participant withdrew consent | 0 | 0 | 1 | 0 | 4 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 2 |
| Treatment Period | Study drug toxicity | 1 | 0 | 1 | 2 | 0 | 3 | 1 | 1 | 3 | 2 | 0 | 2 | 0 | 0 | 2 | 3 | 3 | 3 | 1 | 2 | 2 | 0 | 2 | 6 | 7 | 6 |
Baseline characteristics
| Characteristic | Part 1A: BMS-986218 2 mg All Solid Tumors | Part 1A: BMS-986218 4 mg All Solid Tumors | Part 1A: BMS-986218 7 mg All Solid Tumors | Part 1A: BMS-986218 20 mg All Solid Tumors | Part 1A: BMS-986218 40 mg All Solid Tumors | Part 1A: BMS-986218 70 mg All Solid Tumors | Part 1A: BMS-986218 100 mg All Solid Tumors | Part 1A: BMS-986218 150 mg All Solid Tumors | Part 1A: BMS-986218 200 mg All Solid Tumors | Part 1A: BMS-986218 20 mg Select Solid Tumors | Part 1A: BMS-986218 35 mg Select Solid Tumors | Part 1A: BMS-986218 50 mg Select Solid Tumors | Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Part 2A: Ipilimumab Cutaneous Melanoma | Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 49.5 Years STANDARD_DEVIATION 23.1 | 63.6 Years STANDARD_DEVIATION 11.4 | 65.6 Years STANDARD_DEVIATION 11.1 | 63.3 Years STANDARD_DEVIATION 8.3 | 60.6 Years STANDARD_DEVIATION 12.1 | 55.1 Years STANDARD_DEVIATION 9.5 | 58.7 Years STANDARD_DEVIATION 6.1 | 65.5 Years STANDARD_DEVIATION 10.1 | 57.8 Years STANDARD_DEVIATION 10.2 | 60.1 Years STANDARD_DEVIATION 12.2 | 64.7 Years STANDARD_DEVIATION 6.7 | 54.5 Years STANDARD_DEVIATION 4.1 | 76.0 Years STANDARD_DEVIATION 0 | 70.4 Years STANDARD_DEVIATION 6.1 | 58.7 Years STANDARD_DEVIATION 11.3 | 61.1 Years STANDARD_DEVIATION 9.5 | 57.7 Years STANDARD_DEVIATION 9.7 | 65.6 Years STANDARD_DEVIATION 11.6 | 61.8 Years STANDARD_DEVIATION 14.4 | 65.8 Years STANDARD_DEVIATION 14.6 | 64.6 Years STANDARD_DEVIATION 13.2 | 66.0 Years STANDARD_DEVIATION 8.6 | 65.9 Years STANDARD_DEVIATION 11.2 | 62.8 Years STANDARD_DEVIATION 7.4 | 62.7 Years STANDARD_DEVIATION 9.8 | 55.3 Years STANDARD_DEVIATION 11.5 | 61.7 Years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 7 Participants | 5 Participants | 0 Participants | 5 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 6 Participants | 10 Participants | 11 Participants | 11 Participants | 12 Participants | 5 Participants | 8 Participants | 4 Participants | 10 Participants | 4 Participants | 2 Participants | 0 Participants | 3 Participants | 12 Participants | 6 Participants | 3 Participants | 7 Participants | 5 Participants | 5 Participants | 3 Participants | 8 Participants | 13 Participants | 5 Participants | 10 Participants | 11 Participants | 177 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 4 Participants | 13 Participants | 4 Participants | 9 Participants | 7 Participants | 8 Participants | 15 Participants | 9 Participants | 6 Participants | 16 Participants | 18 Participants | 32 Participants | 160 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 14 Participants |
| Race (NIH/OMB) White | 3 Participants | 9 Participants | 9 Participants | 15 Participants | 10 Participants | 9 Participants | 7 Participants | 10 Participants | 4 Participants | 13 Participants | 6 Participants | 4 Participants | 0 Participants | 5 Participants | 13 Participants | 18 Participants | 6 Participants | 20 Participants | 19 Participants | 18 Participants | 18 Participants | 22 Participants | 21 Participants | 21 Participants | 29 Participants | 42 Participants | 351 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 4 Participants | 6 Participants | 7 Participants | 8 Participants | 5 Participants | 7 Participants | 2 Participants | 9 Participants | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 5 Participants | 8 Participants | 7 Participants | 10 Participants | 9 Participants | 11 Participants | 4 Participants | 10 Participants | 7 Participants | 6 Participants | 16 Participants | 24 Participants | 175 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 8 Participants | 9 Participants | 5 Participants | 6 Participants | 2 Participants | 4 Participants | 3 Participants | 5 Participants | 6 Participants | 1 Participants | 1 Participants | 3 Participants | 12 Participants | 11 Participants | 0 Participants | 10 Participants | 10 Participants | 7 Participants | 14 Participants | 12 Participants | 15 Participants | 16 Participants | 13 Participants | 20 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 4 | 7 / 9 | 6 / 12 | 10 / 15 | 8 / 12 | 7 / 14 | 6 / 7 | 10 / 11 | 1 / 5 | 9 / 14 | 6 / 6 | 3 / 4 | 1 / 1 | 4 / 5 | 15 / 17 | 14 / 19 | 5 / 7 | 13 / 20 | 16 / 19 | 16 / 18 | 18 / 18 | 19 / 22 | 20 / 22 | 16 / 22 | 28 / 29 | 37 / 44 |
| other Total, other adverse events | 4 / 4 | 9 / 9 | 11 / 12 | 15 / 15 | 11 / 12 | 14 / 14 | 7 / 7 | 11 / 11 | 5 / 5 | 13 / 14 | 5 / 6 | 4 / 4 | 1 / 1 | 5 / 5 | 16 / 17 | 19 / 19 | 7 / 7 | 18 / 20 | 19 / 19 | 15 / 18 | 16 / 18 | 21 / 22 | 21 / 22 | 21 / 22 | 27 / 29 | 43 / 44 |
| serious Total, serious adverse events | 2 / 4 | 5 / 9 | 5 / 12 | 9 / 15 | 10 / 12 | 7 / 14 | 5 / 7 | 7 / 11 | 5 / 5 | 10 / 14 | 4 / 6 | 3 / 4 | 1 / 1 | 3 / 5 | 13 / 17 | 18 / 19 | 7 / 7 | 9 / 20 | 11 / 19 | 12 / 18 | 12 / 18 | 16 / 22 | 15 / 22 | 17 / 22 | 23 / 29 | 34 / 44 |
Outcome results
Primary
Median Duration of Response (mDOR) for Part 2 Only
Duration of response (DOR) for a participant with a BOR of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1 or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response
Time frame: From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months)
Population: All confirmed responders in Part 2 whose best overall response (BOR) is either complete response (CR) or partial response (PR). Pre-specified to be reported for Part 2 only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Median Duration of Response (mDOR) for Part 2 Only | 20.53 Months |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Median Duration of Response (mDOR) for Part 2 Only | 4.75 Months |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Median Duration of Response (mDOR) for Part 2 Only | 7.89 Months |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Median Duration of Response (mDOR) for Part 2 Only | 5.52 Months |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Median Duration of Response (mDOR) for Part 2 Only | NA Months |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Median Duration of Response (mDOR) for Part 2 Only | NA Months |
Primary
Number of Participants Who Died
Number of participants who died during the study
Time frame: From randomization (Part 2A and 2B) or first dose (Part 1, 2C and 2D) until study closure (Up to approximately 83 months)
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Number of Participants Who Died | 2 Participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Number of Participants Who Died | 7 Participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Number of Participants Who Died | 6 Participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Number of Participants Who Died | 10 Participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Number of Participants Who Died | 8 Participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Number of Participants Who Died | 7 Participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Number of Participants Who Died | 6 Participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Number of Participants Who Died | 10 Participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Number of Participants Who Died | 1 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Number of Participants Who Died | 9 Participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Number of Participants Who Died | 6 Participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Number of Participants Who Died | 3 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Number of Participants Who Died | 1 Participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants Who Died | 4 Participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants Who Died | 15 Participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants Who Died | 14 Participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants Who Died | 5 Participants |
| Part 2A: Ipilimumab Cutaneous Melanoma | Number of Participants Who Died | 13 Participants |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Number of Participants Who Died | 16 Participants |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Number of Participants Who Died | 16 Participants |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Number of Participants Who Died | 18 Participants |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants Who Died | 19 Participants |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants Who Died | 20 Participants |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants Who Died | 16 Participants |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Number of Participants Who Died | 28 Participants |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Number of Participants Who Died | 37 Participants |
Primary
Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) | 4 Participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) | 9 Participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) | 11 Participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) | 15 Participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) | 12 Participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) | 14 Participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) | 7 Participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) | 11 Participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) | 5 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) | 13 Participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) | 6 Participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) | 4 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Number of Participants With Adverse Events (AEs) | 1 Participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) | 5 Participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) | 17 Participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) | 19 Participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) | 7 Participants |
| Part 2A: Ipilimumab Cutaneous Melanoma | Number of Participants With Adverse Events (AEs) | 18 Participants |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Number of Participants With Adverse Events (AEs) | 19 Participants |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Number of Participants With Adverse Events (AEs) | 15 Participants |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Number of Participants With Adverse Events (AEs) | 17 Participants |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Adverse Events (AEs) | 21 Participants |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Adverse Events (AEs) | 22 Participants |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Adverse Events (AEs) | 22 Participants |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Adverse Events (AEs) | 29 Participants |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Number of Participants With Adverse Events (AEs) | 44 Participants |
Primary
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 1 Participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 0 Participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 1 Participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 2 Participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 0 Participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 3 Participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 1 Participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 1 Participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 3 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 2 Participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 0 Participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 2 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 0 Participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 0 Participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 2 Participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 3 Participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 3 Participants |
| Part 2A: Ipilimumab Cutaneous Melanoma | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 3 Participants |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 1 Participants |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 2 Participants |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 2 Participants |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 0 Participants |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 2 Participants |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 6 Participants |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 7 Participants |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 6 Participants |
Primary
Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment. Grade 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death Gastrointestinal DLT: * Grade 2 colitis \>5 days * Grade ≥3 diarrhea/colitis Hepatic DLT: * Grade 4 serum transaminases (AST & ALT), alkaline phosphatase (ALP), or total bilirubin elevations * Grade 3 serum AST, ALT, or ALP elevations lasting \>5 days or with clinical symptoms or bilirubin \> 2×ULN without cholestasis Hematologic DLT: * Grade 4 neutropenia ≥7 days * Grade 4 thrombocytopenia Dermatologic DLT: * Grade 4 rash * Grade 3 rash if no improvement after 1-2-week infusion delay Other DLTs: * Grade 2 drug-related uveitis, episcleritis, iritis, eye pain, or blurred vision that doesn't respond to treatment, doesn't improve within the re-treatment period OR requires systemic treatment * Grade 3 drug-related uveitis, episcleritis, iritis, pneumonitis, bronchospasm, or neurologic toxicity
Time frame: From first dose of study medication through 60 days following last dose of study treatment (assessed for an average of 7 months up to a max of approximately 27 months)
Population: All DLT Evaluable Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 1 Participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 1 Participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 2 Participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 2 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 1 Participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 2 Participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 3 Participants |
| Part 2A: Ipilimumab Cutaneous Melanoma | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Time frame: From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 5 Participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 5 Participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 9 Participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 10 Participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 7 Participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 5 Participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 7 Participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 5 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 10 Participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 4 Participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 13 Participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 18 Participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Serious Adverse Events (SAEs) | 7 Participants |
| Part 2A: Ipilimumab Cutaneous Melanoma | Number of Participants With Serious Adverse Events (SAEs) | 9 Participants |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Number of Participants With Serious Adverse Events (SAEs) | 11 Participants |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Number of Participants With Serious Adverse Events (SAEs) | 12 Participants |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Number of Participants With Serious Adverse Events (SAEs) | 12 Participants |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Serious Adverse Events (SAEs) | 16 Participants |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Serious Adverse Events (SAEs) | 15 Participants |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Serious Adverse Events (SAEs) | 17 Participants |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Serious Adverse Events (SAEs) | 23 Participants |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Number of Participants With Serious Adverse Events (SAEs) | 34 Participants |
Primary
Objective Response Rate (ORR) for Part 2 Only
Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Time frame: From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months)
Population: All Treated Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Objective Response Rate (ORR) for Part 2 Only | 25.0 Percent of participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Objective Response Rate (ORR) for Part 2 Only | 10.5 Percent of participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Objective Response Rate (ORR) for Part 2 Only | 5.6 Percent of participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Objective Response Rate (ORR) for Part 2 Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Objective Response Rate (ORR) for Part 2 Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Objective Response Rate (ORR) for Part 2 Only | 4.5 Percent of participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Objective Response Rate (ORR) for Part 2 Only | 4.5 Percent of participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Objective Response Rate (ORR) for Part 2 Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Objective Response Rate (ORR) for Part 2 Only | 4.5 Percent of participants |
Primary
Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only
Progression-free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Based on Kaplan-Meier estimates of progression-free survival rate Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Time frame: At 24, 36, and 48 weeks
Population: All treated participants for Part 2 only. Pre-specified to be reported for Part 2 only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 24 Weeks | 31.9 Percent of participants |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 36 Weeks | 19.1 Percent of participants |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 48 Weeks | 19.1 Percent of participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 48 Weeks | 5.6 Percent of participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 24 Weeks | 22.2 Percent of participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 36 Weeks | 11.1 Percent of participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 48 Weeks | 5.6 Percent of participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 24 Weeks | 11.1 Percent of participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 36 Weeks | 11.1 Percent of participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 36 Weeks | 5.6 Percent of participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 48 Weeks | 5.6 Percent of participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 24 Weeks | 11.1 Percent of participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 24 Weeks | 9.1 Percent of participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 36 Weeks | 9.1 Percent of participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 48 Weeks | 9.1 Percent of participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 24 Weeks | 16.3 Percent of participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 36 Weeks | 16.3 Percent of participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 48 Weeks | 5.4 Percent of participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 36 Weeks | 18.8 Percent of participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 24 Weeks | 37.5 Percent of participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 48 Weeks | 18.8 Percent of participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 36 Weeks | 7.8 Percent of participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 24 Weeks | 11.7 Percent of participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 48 Weeks | 7.8 Percent of participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 24 Weeks | 7.9 Percent of participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 36 Weeks | 7.9 Percent of participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only | 48 Weeks | 5.2 Percent of participants |
Secondary
Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218
Time frame: At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Population: All treated participants with accumulation index ratio of AUC at steady state to that after the first dose were measured at Cycle 3 Day 1
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.09 Ratio | Geometric Coefficient of Variation 0.69 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.16 Ratio | Geometric Coefficient of Variation 28.89 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.43 Ratio | Geometric Coefficient of Variation 26.71 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.29 Ratio | Geometric Coefficient of Variation 25 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 0.81 Ratio | Geometric Coefficient of Variation 17.94 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.16 Ratio | — |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.09 Ratio | Geometric Coefficient of Variation 8.11 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.16 Ratio | Geometric Coefficient of Variation 17.02 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.49 Ratio | Geometric Coefficient of Variation 2.93 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.43 Ratio | Geometric Coefficient of Variation 54.87 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.28 Ratio | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.52 Ratio | — |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.09 Ratio | Geometric Coefficient of Variation 15.24 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.09 Ratio | Geometric Coefficient of Variation 15.52 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.13 Ratio | Geometric Coefficient of Variation 13.09 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.13 Ratio | — |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.36 Ratio | Geometric Coefficient of Variation 96.87 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.37 Ratio | Geometric Coefficient of Variation 104.97 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 0.93 Ratio | Geometric Coefficient of Variation 25.69 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.48 Ratio | Geometric Coefficient of Variation 47.11 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 0.98 Ratio | Geometric Coefficient of Variation 34.75 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.29 Ratio | Geometric Coefficient of Variation 27.7 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.04 Ratio | Geometric Coefficient of Variation 19.75 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218 | 1.18 Ratio | Geometric Coefficient of Variation 31.02 |
Secondary
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218
Tmax is the time taken to reach the maximum observed serum concentration (Cmax) for BMS-986218.
Time frame: On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Population: All PK participants with available PK results at each time point
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 106995.38 h*ng/mL | Geometric Coefficient of Variation 25.94 |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 38482.79 h*ng/mL | Geometric Coefficient of Variation 67.05 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 180870.63 h*ng/mL | Geometric Coefficient of Variation 13.77 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 152995.20 h*ng/mL | Geometric Coefficient of Variation 24.9 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 338090.13 h*ng/mL | Geometric Coefficient of Variation 44.06 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 320865.91 h*ng/mL | Geometric Coefficient of Variation 52.33 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 916409.73 h*ng/mL | Geometric Coefficient of Variation 31.83 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 859624.01 h*ng/mL | Geometric Coefficient of Variation 35 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 1231569.13 h*ng/mL | Geometric Coefficient of Variation 60.51 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 1374751.12 h*ng/mL | Geometric Coefficient of Variation 41.91 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 2800743.92 h*ng/mL | Geometric Coefficient of Variation 34.47 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 4712195.98 h*ng/mL | Geometric Coefficient of Variation 22.69 |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 4496192.21 h*ng/mL | Geometric Coefficient of Variation 30.37 |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 4813781.16 h*ng/mL | Geometric Coefficient of Variation 28.58 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 6332567.97 h*ng/mL | Geometric Coefficient of Variation 32.76 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 7327105.74 h*ng/mL | Geometric Coefficient of Variation 35.84 |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 6471486.44 h*ng/mL | Geometric Coefficient of Variation 42.01 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 829253.53 h*ng/mL | Geometric Coefficient of Variation 24.59 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 15 | 666441.31 h*ng/mL | Geometric Coefficient of Variation 50.63 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 15 | 753989.60 h*ng/mL | Geometric Coefficient of Variation 57.54 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 555237.58 h*ng/mL | Geometric Coefficient of Variation 35.05 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 15 | 812419.15 h*ng/mL | Geometric Coefficient of Variation 67.75 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 15 | 1853267.79 h*ng/mL | Geometric Coefficient of Variation 11.48 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 1673664.31 h*ng/mL | Geometric Coefficient of Variation 29.67 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 911929.11 h*ng/mL | Geometric Coefficient of Variation 36.66 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 1878893.05 h*ng/mL | Geometric Coefficient of Variation 27.29 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 15 | 1619652.01 h*ng/mL | — |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 15 | 2710445.36 h*ng/mL | Geometric Coefficient of Variation 7.15 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 1162456.20 h*ng/mL | Geometric Coefficient of Variation 123.44 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 698634.55 h*ng/mL | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 1058967.60 h*ng/mL | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 15 | 732535.33 h*ng/mL | — |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 284245.76 h*ng/mL | Geometric Coefficient of Variation 46.27 |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 346844.14 h*ng/mL | Geometric Coefficient of Variation 43.83 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 586413.48 h*ng/mL | Geometric Coefficient of Variation 57.48 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 568755.53 h*ng/mL | Geometric Coefficient of Variation 50.38 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 1196906.59 h*ng/mL | Geometric Coefficient of Variation 39.01 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 1530718.58 h*ng/mL | Geometric Coefficient of Variation 31.46 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 2675458.62 h*ng/mL | Geometric Coefficient of Variation 25.81 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 2090995.50 h*ng/mL | — |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 362116.78 h*ng/mL | Geometric Coefficient of Variation 42.58 |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 242498.24 h*ng/mL | Geometric Coefficient of Variation 71.75 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 1070790.34 h*ng/mL | Geometric Coefficient of Variation 205.76 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 1001283.21 h*ng/mL | Geometric Coefficient of Variation 50.58 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 3086017.57 h*ng/mL | Geometric Coefficient of Variation 21.62 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 2152498.70 h*ng/mL | Geometric Coefficient of Variation 42.12 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 352268.83 h*ng/mL | Geometric Coefficient of Variation 78.8 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 303622.32 h*ng/mL | Geometric Coefficient of Variation 52.88 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 1067646.86 h*ng/mL | Geometric Coefficient of Variation 40.62 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 982950.43 h*ng/mL | Geometric Coefficient of Variation 51.34 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 2733292.53 h*ng/mL | Geometric Coefficient of Variation 35.02 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 3653192.45 h*ng/mL | Geometric Coefficient of Variation 34.54 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 1461119.11 h*ng/mL | Geometric Coefficient of Variation 35.96 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 1609530.93 h*ng/mL | Geometric Coefficient of Variation 45.25 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 3 Day 1 | 1716552.20 h*ng/mL | Geometric Coefficient of Variation 22.69 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218 | Cycle 1 Day 1 | 1380362.22 h*ng/mL | Geometric Coefficient of Variation 42.32 |
Secondary
Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218
AUC (TAU) is the area measured under the concentration-time curve taken over the dosing interval for BMS-986218.
Time frame: On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Population: All PK participants with available PK results at each time point
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 102107.56 h*ng/mL | Geometric Coefficient of Variation 20.44 |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 110809.32 h*ng/mL | Geometric Coefficient of Variation 21.12 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 160708.57 h*ng/mL | Geometric Coefficient of Variation 21.45 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 189406.70 h*ng/mL | Geometric Coefficient of Variation 12.74 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 460618.56 h*ng/mL | Geometric Coefficient of Variation 29.45 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 376035.72 h*ng/mL | Geometric Coefficient of Variation 38.14 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 946000.30 h*ng/mL | Geometric Coefficient of Variation 44.09 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 894413.40 h*ng/mL | Geometric Coefficient of Variation 35.17 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 1421515.99 h*ng/mL | Geometric Coefficient of Variation 40.74 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 1265811.65 h*ng/mL | Geometric Coefficient of Variation 67.93 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 4008112.03 h*ng/mL | — |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 3027482.69 h*ng/mL | Geometric Coefficient of Variation 33.3 |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 4816815.14 h*ng/mL | Geometric Coefficient of Variation 23.87 |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 5131052.16 h*ng/mL | Geometric Coefficient of Variation 1.63 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 6599896.79 h*ng/mL | Geometric Coefficient of Variation 22.75 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 7635138.59 h*ng/mL | Geometric Coefficient of Variation 31.66 |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 7560614.03 h*ng/mL | Geometric Coefficient of Variation 28.48 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 15 | 791252.01 h*ng/mL | Geometric Coefficient of Variation 42.41 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 15 | 1161185.91 h*ng/mL | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 604538.01 h*ng/mL | Geometric Coefficient of Variation 32.38 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 829253.53 h*ng/mL | Geometric Coefficient of Variation 24.59 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 15 | 1254494.19 h*ng/mL | Geometric Coefficient of Variation 41.07 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 984127.10 h*ng/mL | Geometric Coefficient of Variation 33.75 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 15 | 1853267.79 h*ng/mL | Geometric Coefficient of Variation 11.48 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 1673664.31 h*ng/mL | Geometric Coefficient of Variation 29.67 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 1878893.05 h*ng/mL | Geometric Coefficient of Variation 27.29 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 15 | 2710445.36 h*ng/mL | Geometric Coefficient of Variation 7.15 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 3363278.02 h*ng/mL | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 698634.55 h*ng/mL | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 1058967.60 h*ng/mL | — |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 346844.14 h*ng/mL | Geometric Coefficient of Variation 43.83 |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 284245.76 h*ng/mL | Geometric Coefficient of Variation 46.27 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 827831.27 h*ng/mL | Geometric Coefficient of Variation 33.07 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 765535.55 h*ng/mL | Geometric Coefficient of Variation 37.86 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 1569751.67 h*ng/mL | Geometric Coefficient of Variation 32.78 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 1400907.18 h*ng/mL | Geometric Coefficient of Variation 31.92 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 2736051.44 h*ng/mL | Geometric Coefficient of Variation 25.5 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 2090995.50 h*ng/mL | — |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 355092.73 h*ng/mL | Geometric Coefficient of Variation 43.6 |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 438160.20 h*ng/mL | Geometric Coefficient of Variation 44.33 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 1107418.00 h*ng/mL | Geometric Coefficient of Variation 43.18 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 1777132.02 h*ng/mL | Geometric Coefficient of Variation 156.77 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 2986930.70 h*ng/mL | Geometric Coefficient of Variation 24.5 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 3074048.83 h*ng/mL | Geometric Coefficient of Variation 19.62 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 366958.19 h*ng/mL | Geometric Coefficient of Variation 75.83 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 471293.82 h*ng/mL | Geometric Coefficient of Variation 33.36 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 1096040.02 h*ng/mL | Geometric Coefficient of Variation 38.84 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 1189672.74 h*ng/mL | Geometric Coefficient of Variation 38.19 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 2884299.15 h*ng/mL | Geometric Coefficient of Variation 30.8 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 3636946.89 h*ng/mL | Geometric Coefficient of Variation 34.65 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 1650434.22 h*ng/mL | Geometric Coefficient of Variation 44.45 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 1488804.73 h*ng/mL | Geometric Coefficient of Variation 35.18 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 1 Day 1 | 1516016.83 h*ng/mL | Geometric Coefficient of Variation 38.72 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218 | Cycle 3 Day 1 | 1760069.89 h*ng/mL | Geometric Coefficient of Variation 26.26 |
Secondary
Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218
Time frame: At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Population: All treated participants with average concentration over a dosing interval at steady state were measured at Cycle 3 Day 1
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 165.22 ng/mL | Geometric Coefficient of Variation 21.39 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 282.04 ng/mL | Geometric Coefficient of Variation 12.75 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 686.31 ng/mL | Geometric Coefficient of Variation 29.48 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 1393.64 ng/mL | Geometric Coefficient of Variation 45.15 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 1881.64 ng/mL | Geometric Coefficient of Variation 68.23 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 5980.92 ng/mL | — |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 7644.60 ng/mL | Geometric Coefficient of Variation 1.8 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 11589.37 ng/mL | Geometric Coefficient of Variation 35.71 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 2420.43 ng/mL | Geometric Coefficient of Variation 20.98 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 5006.22 ng/mL | Geometric Coefficient of Variation 29.63 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 10009.76 ng/mL | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 3142.64 ng/mL | — |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 448.98 ng/mL | Geometric Coefficient of Variation 43.83 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 1234.39 ng/mL | Geometric Coefficient of Variation 32.97 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 2334.85 ng/mL | Geometric Coefficient of Variation 32.57 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 2490.67 ng/mL | — |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 659.08 ng/mL | Geometric Coefficient of Variation 44.76 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 2633.76 ng/mL | Geometric Coefficient of Variation 157.01 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 4303.25 ng/mL | Geometric Coefficient of Variation 21.87 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 685.48 ng/mL | Geometric Coefficient of Variation 34.93 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 1760.14 ng/mL | Geometric Coefficient of Variation 35.04 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 5347.42 ng/mL | Geometric Coefficient of Variation 32.03 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 2429.04 ng/mL | Geometric Coefficient of Variation 43.75 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218 | 2627.53 ng/mL | Geometric Coefficient of Variation 26.08 |
Secondary
Maximum Observed Serum Concentration (Cmax) for BMS-986218
Cmax is the maximum observed serum concentration for BMS-986218.
Time frame: On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Population: All PK participants with available BMS-986218 PK results at each time point. Participants in Part 2A Ipilimumab Cutaneous Melanoma did not receive BMS-986218 and hence BMS-986218 PK data can not be reported for this group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 636.63 ng/mL | Geometric Coefficient of Variation 12.17 |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 378.20 ng/mL | Geometric Coefficient of Variation 69.94 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 1041.61 ng/mL | Geometric Coefficient of Variation 22.08 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 898.37 ng/mL | Geometric Coefficient of Variation 35.77 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 1918.89 ng/mL | Geometric Coefficient of Variation 27.17 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 1984.34 ng/mL | Geometric Coefficient of Variation 20.51 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 5013.30 ng/mL | Geometric Coefficient of Variation 40.59 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 5162.91 ng/mL | Geometric Coefficient of Variation 31.89 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 9461.39 ng/mL | Geometric Coefficient of Variation 51.18 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 10167.06 ng/mL | Geometric Coefficient of Variation 34.47 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 19191.31 ng/mL | Geometric Coefficient of Variation 23.63 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 23878.44 ng/mL | Geometric Coefficient of Variation 10.92 |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 26728.01 ng/mL | Geometric Coefficient of Variation 38.43 |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 28404.67 ng/mL | Geometric Coefficient of Variation 25.91 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 38955.95 ng/mL | Geometric Coefficient of Variation 46.84 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 40591.79 ng/mL | Geometric Coefficient of Variation 11.96 |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 34268.86 ng/mL | Geometric Coefficient of Variation 30.14 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 5198.25 ng/mL | Geometric Coefficient of Variation 15.55 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 15 | 6039.57 ng/mL | Geometric Coefficient of Variation 32.03 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 15 | 5485.98 ng/mL | Geometric Coefficient of Variation 30.7 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 5198.38 ng/mL | Geometric Coefficient of Variation 23.13 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 15 | 8958.71 ng/mL | Geometric Coefficient of Variation 30.62 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 15 | 9090.35 ng/mL | Geometric Coefficient of Variation 13.17 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 9896.67 ng/mL | Geometric Coefficient of Variation 9.69 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 6774.51 ng/mL | Geometric Coefficient of Variation 32.4 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 13852.30 ng/mL | Geometric Coefficient of Variation 22.4 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 15 | 13100.00 ng/mL | — |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 15 | 17041.16 ng/mL | Geometric Coefficient of Variation 16.18 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 17526.84 ng/mL | Geometric Coefficient of Variation 32.21 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 3800.00 ng/mL | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 5870.00 ng/mL | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 15 | 6540.00 ng/mL | — |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 1849.00 ng/mL | Geometric Coefficient of Variation 25.58 |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 2196.42 ng/mL | Geometric Coefficient of Variation 34.99 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 3568.33 ng/mL | Geometric Coefficient of Variation 47.96 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 4009.69 ng/mL | Geometric Coefficient of Variation 40.55 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 7672.60 ng/mL | Geometric Coefficient of Variation 39.22 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 7900.78 ng/mL | Geometric Coefficient of Variation 29.53 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 17399.93 ng/mL | Geometric Coefficient of Variation 29.04 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 14300.00 ng/mL | — |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 2096.56 ng/mL | Geometric Coefficient of Variation 42.66 |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 2430.88 ng/mL | Geometric Coefficient of Variation 30.45 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 7837.32 ng/mL | Geometric Coefficient of Variation 169.78 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 4759.66 ng/mL | Geometric Coefficient of Variation 46.15 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 17121.28 ng/mL | Geometric Coefficient of Variation 22.99 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 16491.17 ng/mL | Geometric Coefficient of Variation 26.01 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 2207.18 ng/mL | Geometric Coefficient of Variation 102.83 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 2812.74 ng/mL | Geometric Coefficient of Variation 52.12 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 5890.68 ng/mL | Geometric Coefficient of Variation 60.79 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 6236.74 ng/mL | Geometric Coefficient of Variation 37.92 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 16114.18 ng/mL | Geometric Coefficient of Variation 37.86 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 23527.72 ng/mL | Geometric Coefficient of Variation 50.87 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 9545.23 ng/mL | Geometric Coefficient of Variation 39.78 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 10711.87 ng/mL | Geometric Coefficient of Variation 28.93 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 3 Day 1 | 10317.85 ng/mL | Geometric Coefficient of Variation 42.91 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Maximum Observed Serum Concentration (Cmax) for BMS-986218 | Cycle 1 Day 1 | 8977.53 ng/mL | Geometric Coefficient of Variation 38.23 |
Secondary
Median Duration of Response (mDOR) for Part1A and Part1B Only
Duration of response (DOR) for a participant with a BOR of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1 or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response
Time frame: From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months)
Population: All treated participants in Part1A and Part1B. Pre-specified to be collected for Part1A and Part1B only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 14.3 Percent of participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 7.1 Percent of participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 5.3 Percent of participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Median Duration of Response (mDOR) for Part1A and Part1B Only | 28.6 Percent of participants |
Secondary
Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218
Baseline ADA Positive: Participant with baseline ADA-positive sample ADA Positive: Participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment Persistent Positive (PP): ADA-positive sample at 2 or more consecutive timepoints, where the first and last ADA-positive samples are at least 16weeks apart Not PP-Last Sample Positive: Not persistent but with ADA-positive sample at the last sampling timepoint Other Positive: Not persistent but some ADA-positive samples with the last sample being negative ADA Negative: Participant with no ADA-positive sample after initiation of treatment
Time frame: From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
Population: All Treated Participants with BMS-986128 Who have Baseline and at Least One Post-baseline Pre-infusion ADA Assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 4 Participants |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 6 Participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 1 Participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 1 Participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 10 Participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 12 Participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 1 Participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 1 Participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 1 Participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 9 Participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 1 Participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 1 Participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 7 Participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 3 Participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 2 Participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 1 Participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 1 Participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 3 Participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 7 Participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 5 Participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 7 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 1 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 1 Participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 1 Participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 5 Participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 2 Participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 1 Participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 1 Participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 1 Participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 4 Participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 2 Participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 2 Participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 10 Participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 11 Participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 6 Participants |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 2 Participants |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 18 Participants |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 13 Participants |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 1 Participants |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 1 Participants |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 1 Participants |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 10 Participants |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 1 Participants |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 1 Participants |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 19 Participants |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 18 Participants |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 1 Participants |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 1 Participants |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 1 Participants |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 17 Participants |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 20 Participants |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Not PP-Last Sample Positive] | 0 Participants |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Other Positive] | 0 Participants |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive | 0 Participants |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Positive [Persistent Positive (PP)] | 0 Participants |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | Baseline ADA Positive | 0 Participants |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218 | ADA Negative | 26 Participants |
Secondary
Objective Response Rate (ORR) for Part1A and Part1B Only
Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Time frame: From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months)
Population: All treated participants in Part1A and Part1B. Pre-specified to be collected for Part1A and Part1B only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 14.3 Percent of participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 7.1 Percent of participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 0.0 Percent of participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 5.3 Percent of participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Objective Response Rate (ORR) for Part1A and Part1B Only | 28.6 Percent of participants |
Secondary
Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218
Ctau is the observed serum concentration at the end of the dosing interval for BMS-986218.
Time frame: On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Population: All PK participants with available PK results at each time point
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 39.29 ng/mL | Geometric Coefficient of Variation 18.84 |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 43.06 ng/mL | Geometric Coefficient of Variation 73.1 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 88.58 ng/mL | Geometric Coefficient of Variation 30.12 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 54.25 ng/mL | Geometric Coefficient of Variation 46.26 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 239.24 ng/mL | Geometric Coefficient of Variation 37.53 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 184.40 ng/mL | Geometric Coefficient of Variation 53.72 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 275.23 ng/mL | Geometric Coefficient of Variation 54.82 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 304.84 ng/mL | Geometric Coefficient of Variation 66.34 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 262.71 ng/mL | Geometric Coefficient of Variation 106.82 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 293.28 ng/mL | Geometric Coefficient of Variation 82.69 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 792.03 ng/mL | Geometric Coefficient of Variation 76.23 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 2310.00 ng/mL | — |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 2089.02 ng/mL | Geometric Coefficient of Variation 33.02 |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 1600.37 ng/mL | Geometric Coefficient of Variation 31.94 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 3151.12 ng/mL | Geometric Coefficient of Variation 64.09 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 2396.65 ng/mL | Geometric Coefficient of Variation 51.08 |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 2659.87 ng/mL | Geometric Coefficient of Variation 32.41 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 15 | 1016.63 ng/mL | Geometric Coefficient of Variation 57.51 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 703.99 ng/mL | Geometric Coefficient of Variation 45.94 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 15 | 1980.00 ng/mL | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 1098.35 ng/mL | Geometric Coefficient of Variation 31.92 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 2723.07 ng/mL | Geometric Coefficient of Variation 23.06 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 15 | 3212.85 ng/mL | Geometric Coefficient of Variation 27.42 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 1284.78 ng/mL | Geometric Coefficient of Variation 42.93 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 15 | 1651.22 ng/mL | Geometric Coefficient of Variation 51.66 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 15 | 3630.54 ng/mL | Geometric Coefficient of Variation 21.56 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 2793.34 ng/mL | Geometric Coefficient of Variation 31.31 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 5161.39 ng/mL | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 1090.00 ng/mL | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 1550.00 ng/mL | — |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 99.96 ng/mL | Geometric Coefficient of Variation 45.22 |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 140.76 ng/mL | Geometric Coefficient of Variation 67.67 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 176.14 ng/mL | Geometric Coefficient of Variation 63.8 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 294.67 ng/mL | Geometric Coefficient of Variation 34.83 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 559.93 ng/mL | Geometric Coefficient of Variation 63 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 466.01 ng/mL | Geometric Coefficient of Variation 67.94 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 339.00 ng/mL | — |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 667.59 ng/mL | Geometric Coefficient of Variation 62.14 |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 140.54 ng/mL | Geometric Coefficient of Variation 62.61 |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 154.17 ng/mL | Geometric Coefficient of Variation 76.15 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 530.35 ng/mL | Geometric Coefficient of Variation 144.43 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 795.20 ng/mL | Geometric Coefficient of Variation 166.56 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 959.00 ng/mL | Geometric Coefficient of Variation 56.06 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 1033.06 ng/mL | Geometric Coefficient of Variation 33.1 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 195.37 ng/mL | Geometric Coefficient of Variation 39.51 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 133.30 ng/mL | Geometric Coefficient of Variation 118.13 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 379.50 ng/mL | Geometric Coefficient of Variation 62.15 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 442.46 ng/mL | Geometric Coefficient of Variation 66.32 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 1326.75 ng/mL | Geometric Coefficient of Variation 50.09 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 810.78 ng/mL | Geometric Coefficient of Variation 69.02 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 330.53 ng/mL | Geometric Coefficient of Variation 65.42 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 423.20 ng/mL | Geometric Coefficient of Variation 85.57 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 3 Day 1 | 516.44 ng/mL | Geometric Coefficient of Variation 58.12 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218 | Cycle 1 Day 1 | 341.97 ng/mL | Geometric Coefficient of Variation 74.43 |
Secondary
Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only
Progression-free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of progression-free survival rate
Time frame: At 24, 36, and 48 weeks
Population: All treated participants in Part1A and Part1B. Pre-specified to be collected for Part1A and Part1B only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 33.3 Percent of participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 22.2 Percent of participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 22.2 Percent of participants |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 16.7 Percent of participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 7.7 Percent of participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 15.4 Percent of participants |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 7.7 Percent of participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 9.1 Percent of participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 9.1 Percent of participants |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 9.1 Percent of participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 17.1 Percent of participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 9.1 Percent of participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 9.1 Percent of participants |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 9.1 Percent of participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 7.1 Percent of participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 7.1 Percent of participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 16.7 Percent of participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 50.0 Percent of participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 50.0 Percent of participants |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 0.0 Percent of participants |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 0.0 Percent of participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 0.0 Percent of participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 0.0 Percent of participants |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 20.0 Percent of participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 9.5 Percent of participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 0.0 Percent of participants |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 0.0 Percent of participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 11.1 Percent of participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 11.1 Percent of participants |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 11.1 Percent of participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 24 Weeks | 28.6 Percent of participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 36 Weeks | 28.6 Percent of participants |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only | 48 Weeks | 28.6 Percent of participants |
Secondary
Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218
Time frame: At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Population: All treated participants with ratio of an exposure measure at steady state to that after the first dose (exposure measure includes Cmax) were measured at Cycle 3 Day 1
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 0.83 Ratio | Geometric Coefficient of Variation 10.89 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.15 Ratio | Geometric Coefficient of Variation 22.83 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.13 Ratio | Geometric Coefficient of Variation 22.62 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.22 Ratio | Geometric Coefficient of Variation 52.14 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 0.91 Ratio | Geometric Coefficient of Variation 6.4 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.10 Ratio | Geometric Coefficient of Variation 8.26 |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 0.77 Ratio | Geometric Coefficient of Variation 39.73 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.32 Ratio | Geometric Coefficient of Variation 1.53 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.12 Ratio | Geometric Coefficient of Variation 8.28 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.26 Ratio | Geometric Coefficient of Variation 53.95 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.29 Ratio | Geometric Coefficient of Variation 5.21 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.54 Ratio | — |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.07 Ratio | Geometric Coefficient of Variation 8.7 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 0.77 Ratio | Geometric Coefficient of Variation 37.44 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 0.84 Ratio | Geometric Coefficient of Variation 27.1 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.08 Ratio | — |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.19 Ratio | Geometric Coefficient of Variation 80.37 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.71 Ratio | Geometric Coefficient of Variation 115.1 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 0.90 Ratio | Geometric Coefficient of Variation 21.26 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.33 Ratio | Geometric Coefficient of Variation 93.11 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.00 Ratio | Geometric Coefficient of Variation 52.38 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.45 Ratio | Geometric Coefficient of Variation 136.48 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.05 Ratio | Geometric Coefficient of Variation 20.63 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218 | 1.18 Ratio | Geometric Coefficient of Variation 40.84 |
Secondary
Terminal Serum Half-life (T-HALF) for BMS-986218
Time frame: At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Population: All treated participants with terminal serum half-life were measured at Cycle 3 Day 1
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 233.28 hour | Geometric Coefficient of Variation 50.61 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 264.58 hour | Geometric Coefficient of Variation 16.51 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 274.01 hour | Geometric Coefficient of Variation 23.4 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 191.02 hour | Geometric Coefficient of Variation 19.95 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 175.33 hour | Geometric Coefficient of Variation 34.46 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 331.17 hour | — |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 290.94 hour | Geometric Coefficient of Variation 6.57 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 234.91 hour | Geometric Coefficient of Variation 23.01 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 191.02 hour | Geometric Coefficient of Variation 4.42 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 200.61 hour | — |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 211.88 hour | — |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 213.34 hour | Geometric Coefficient of Variation 4.94 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 203.14 hour | Geometric Coefficient of Variation 2.92 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 205.63 hour | Geometric Coefficient of Variation 25.2 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Terminal Serum Half-life (T-HALF) for BMS-986218 | 194.21 hour | — |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Terminal Serum Half-life (T-HALF) for BMS-986218 | 224.90 hour | Geometric Coefficient of Variation 33.11 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Terminal Serum Half-life (T-HALF) for BMS-986218 | 271.49 hour | Geometric Coefficient of Variation 24.13 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Terminal Serum Half-life (T-HALF) for BMS-986218 | 207.59 hour | Geometric Coefficient of Variation 16.53 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Terminal Serum Half-life (T-HALF) for BMS-986218 | 233.09 hour | Geometric Coefficient of Variation 11.04 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Terminal Serum Half-life (T-HALF) for BMS-986218 | 230.66 hour | Geometric Coefficient of Variation 32.95 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Terminal Serum Half-life (T-HALF) for BMS-986218 | 235.80 hour | Geometric Coefficient of Variation 23.08 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Terminal Serum Half-life (T-HALF) for BMS-986218 | 201.22 hour | Geometric Coefficient of Variation 41.29 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Terminal Serum Half-life (T-HALF) for BMS-986218 | 198.93 hour | Geometric Coefficient of Variation 32.68 |
Secondary
Time of Maximum Observed Concentration (Tmax) for BMS-986218
Tmax is the time taken to reach the maximum observed serum concentration (Cmax) for BMS-986218.
Time frame: On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
Population: All PK participants with available PK results at each time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 2.05 hour |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 2.04 hour |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.35 hour |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 2.08 hour |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.48 hour |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.48 hour |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.53 hour |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 12.24 hour |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.52 hour |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.51 hour |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.68 hour |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.54 hour |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.70 hour |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.50 hour |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.53 hour |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.53 hour |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.60 hour |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 15 | 0.53 hour |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.53 hour |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.56 hour |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 15 | 0.52 hour |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 11.51 hour |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 12.41 hour |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 15 | 12.28 hour |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 15 | 12.26 hour |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.53 hour |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 15 | 12.15 hour |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.64 hour |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 15 | 0.53 hour |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.52 hour |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 20.93 hour |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 15 | 0.53 hour |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.27 hour |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.33 hour |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 21.06 hour |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.52 hour |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.60 hour |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.53 hour |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.75 hour |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.62 hour |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.30 hour |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.27 hour |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.58 hour |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.53 hour |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.53 hour |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.58 hour |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.28 hour |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.27 hour |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.56 hour |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 9.88 hour |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.53 hour |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.52 hour |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.68 hour |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.65 hour |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 3 Day 1 | 0.75 hour |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Time of Maximum Observed Concentration (Tmax) for BMS-986218 | Cycle 1 Day 1 | 0.92 hour |
Secondary
Total Body Clearance (CLT/F) for BMS-986218
Time frame: At Cycle 3 Day 1 (Each Cycle is of 28 Days)
Population: All treated participants with total body clearance were measured at Cycle 3 Day 1
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 18.05 mL/h | Geometric Coefficient of Variation 21.12 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 21.12 mL/h | Geometric Coefficient of Variation 13.87 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 15.20 mL/h | Geometric Coefficient of Variation 43.36 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 21.14 mL/h | Geometric Coefficient of Variation 59.06 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 31.60 mL/h | Geometric Coefficient of Variation 61.89 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 17.46 mL/h | — |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 19.49 mL/h | Geometric Coefficient of Variation 1.63 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 19.65 mL/h | Geometric Coefficient of Variation 30.54 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 24.12 mL/h | Geometric Coefficient of Variation 22.83 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 20.91 mL/h | Geometric Coefficient of Variation 29.67 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 14.87 mL/h | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Total Body Clearance (CLT/F) for BMS-986218 | 18.89 mL/h | — |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 24.63 mL/h | Geometric Coefficient of Variation 46.27 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 24.16 mL/h | Geometric Coefficient of Variation 40.86 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 25.48 mL/h | Geometric Coefficient of Variation 37.36 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Total Body Clearance (CLT/F) for BMS-986218 | 33.48 mL/h | — |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Total Body Clearance (CLT/F) for BMS-986218 | 15.98 mL/h | Geometric Coefficient of Variation 51.15 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Total Body Clearance (CLT/F) for BMS-986218 | 11.25 mL/h | Geometric Coefficient of Variation 57.31 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Total Body Clearance (CLT/F) for BMS-986218 | 23.44 mL/h | Geometric Coefficient of Variation 31.87 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Total Body Clearance (CLT/F) for BMS-986218 | 14.85 mL/h | Geometric Coefficient of Variation 27.95 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Total Body Clearance (CLT/F) for BMS-986218 | 16.81 mL/h | Geometric Coefficient of Variation 33.59 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Total Body Clearance (CLT/F) for BMS-986218 | 19.25 mL/h | Geometric Coefficient of Variation 45.86 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Total Body Clearance (CLT/F) for BMS-986218 | 24.24 mL/h | Geometric Coefficient of Variation 60.65 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Total Body Clearance (CLT/F) for BMS-986218 | 22.73 mL/h | Geometric Coefficient of Variation 20.24 |
Secondary
Trough Observed Plasma Concentration (Ctrough) for BMS-986218
Ctrough is the lowest observed serum concentration for BMS-986218.
Time frame: At Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1 (Each Cycle is of 28 Days)
Population: All PK participants with available PK results at each time point
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1A: BMS-986218 2 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 41.86 ng/ml | Geometric Coefficient of Variation 67.07 |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 25.00 ng/ml | Geometric Coefficient of Variation 0 |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 57.70 ng/ml | — |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 7 Day 1 | 80.30 ng/ml | — |
| Part 1A: BMS-986218 2 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 76.30 ng/ml | — |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 7 Day 1 | 46.34 ng/ml | Geometric Coefficient of Variation 77.66 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 65.16 ng/ml | Geometric Coefficient of Variation 60.55 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 13 Day 1 | 67.50 ng/ml | — |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 55.05 ng/ml | Geometric Coefficient of Variation 54.39 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 76.43 ng/ml | Geometric Coefficient of Variation 45.86 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 9 Day 1 | 85.46 ng/ml | Geometric Coefficient of Variation 61.35 |
| Part 1A: BMS-986218 4 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 66.16 ng/ml | Geometric Coefficient of Variation 45.96 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 239.17 ng/ml | Geometric Coefficient of Variation 42.21 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 219.06 ng/ml | Geometric Coefficient of Variation 30.71 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 9 Day 1 | 356.00 ng/ml | — |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 182.56 ng/ml | Geometric Coefficient of Variation 59.17 |
| Part 1A: BMS-986218 7 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 297.97 ng/ml | Geometric Coefficient of Variation 123.19 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 155.00 ng/ml | — |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 341.81 ng/ml | Geometric Coefficient of Variation 49.2 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 457.55 ng/ml | Geometric Coefficient of Variation 55.91 |
| Part 1A: BMS-986218 20 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 149.00 ng/ml | — |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 9 Day 1 | 196.00 ng/ml | — |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 119.37 ng/ml | Geometric Coefficient of Variation 129.54 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 243.09 ng/ml | Geometric Coefficient of Variation 36.27 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 524.48 ng/ml | Geometric Coefficient of Variation 65.16 |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 13 Day 1 | 891.00 ng/ml | — |
| Part 1A: BMS-986218 40 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 229.14 ng/ml | Geometric Coefficient of Variation 72.4 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 1310.07 ng/ml | Geometric Coefficient of Variation 42.38 |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 2310.00 ng/ml | — |
| Part 1A: BMS-986218 70 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 2337.71 ng/ml | Geometric Coefficient of Variation 14.44 |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 2650.00 ng/ml | — |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 1651.31 ng/ml | Geometric Coefficient of Variation 39.58 |
| Part 1A: BMS-986218 100 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 1260.06 ng/ml | Geometric Coefficient of Variation 65.56 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 5028.98 ng/ml | Geometric Coefficient of Variation 43.48 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 2427.50 ng/ml | Geometric Coefficient of Variation 68.46 |
| Part 1A: BMS-986218 150 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 3163.13 ng/ml | Geometric Coefficient of Variation 56.11 |
| Part 1A: BMS-986218 200 mg All Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 2460.51 ng/ml | Geometric Coefficient of Variation 38.43 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 15 | 1063.74 ng/ml | Geometric Coefficient of Variation 53.79 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 1890.00 ng/ml | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 1016.63 ng/ml | Geometric Coefficient of Variation 57.51 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 1174.88 ng/ml | Geometric Coefficient of Variation 44.26 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 9 Day 1 | 1710.00 ng/ml | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 15 | 1273.50 ng/ml | Geometric Coefficient of Variation 25.66 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 1 Day 15 | 751.99 ng/ml | Geometric Coefficient of Variation 42.1 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 1980.00 ng/ml | — |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 15 | 2723.07 ng/ml | Geometric Coefficient of Variation 23.06 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 3840.00 ng/ml | — |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 1651.22 ng/ml | Geometric Coefficient of Variation 51.66 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 3212.85 ng/ml | Geometric Coefficient of Variation 27.42 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 15 | 1547.03 ng/ml | Geometric Coefficient of Variation 61.55 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 1266.41 ng/ml | Geometric Coefficient of Variation 105.11 |
| Part 1A: BMS-986218 35 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 1 Day 15 | 1501.35 ng/ml | Geometric Coefficient of Variation 32.91 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 15 | 3029.39 ng/ml | Geometric Coefficient of Variation 57.4 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 2637.27 ng/ml | Geometric Coefficient of Variation 33.6 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 15 | 1930.00 ng/ml | — |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 1 Day 15 | 2793.34 ng/ml | Geometric Coefficient of Variation 31.31 |
| Part 1A: BMS-986218 50 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 3630.54 ng/ml | Geometric Coefficient of Variation 21.56 |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 1860.00 ng/ml | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 15 | 1450.00 ng/ml | — |
| Part 1A: BMS-986218 20 mg Select Solid Tumors Pharmacodynamics Cohort | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 15 | 1550.00 ng/ml | — |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 140.76 ng/ml | Geometric Coefficient of Variation 67.67 |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 59.16 ng/ml | Geometric Coefficient of Variation 98.57 |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 9 Day 1 | 232.00 ng/ml | — |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 99.96 ng/ml | Geometric Coefficient of Variation 45.22 |
| Part 1B: BMS-986218 7 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 255.00 ng/ml | — |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 217.64 ng/ml | Geometric Coefficient of Variation 62.28 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 159.03 ng/ml | Geometric Coefficient of Variation 70.17 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 448.60 ng/ml | Geometric Coefficient of Variation 8.97 |
| Part 1B: BMS-986218 20 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 191.74 ng/ml | Geometric Coefficient of Variation 68.64 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 592.11 ng/ml | Geometric Coefficient of Variation 63.58 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 1013.99 ng/ml | Geometric Coefficient of Variation 84.49 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 466.94 ng/ml | Geometric Coefficient of Variation 66.02 |
| Part 1B: BMS-986218 40 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 356.38 ng/ml | Geometric Coefficient of Variation 54.16 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 319.00 ng/ml | — |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 607.17 ng/ml | Geometric Coefficient of Variation 75.73 |
| Part 1B: BMS-986218 70 mg + Nivolumab 480 mg Select Solid Tumors | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 339.00 ng/ml | — |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 17 Day 1 | 335.00 ng/ml | — |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 190.56 ng/ml | Geometric Coefficient of Variation 64.87 |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 129.05 ng/ml | Geometric Coefficient of Variation 70.92 |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 209.59 ng/ml | Geometric Coefficient of Variation 52.65 |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 9 Day 1 | 570.00 ng/ml | — |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 158.43 ng/ml | Geometric Coefficient of Variation 77.94 |
| Part 2A: BMS-986218 7 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 13 Day 1 | 533.00 ng/ml | — |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 459.88 ng/ml | Geometric Coefficient of Variation 79.4 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 587.71 ng/ml | Geometric Coefficient of Variation 143 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 536.11 ng/ml | Geometric Coefficient of Variation 51.32 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 704.66 ng/ml | Geometric Coefficient of Variation 24.65 |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 9 Day 1 | 770.00 ng/ml | — |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 17 Day 1 | 357.00 ng/ml | — |
| Part 2A: BMS-986218 20 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 13 Day 1 | 706.00 ng/ml | — |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 961.90 ng/ml | Geometric Coefficient of Variation 41.84 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 9 Day 1 | 932.00 ng/ml | — |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 1064.56 ng/ml | Geometric Coefficient of Variation 48.39 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 850.80 ng/ml | Geometric Coefficient of Variation 10.98 |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 13 Day 1 | 1020.00 ng/ml | — |
| Part 2A: BMS-986218 70 mg Cutaneous Melanoma | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 1902.00 ng/ml | Geometric Coefficient of Variation 31.19 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 17 Day 1 | 231.00 ng/ml | — |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 224.06 ng/ml | Geometric Coefficient of Variation 49.56 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 9 Day 1 | 123.00 ng/ml | — |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 141.23 ng/ml | Geometric Coefficient of Variation 113.06 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 13 Day 1 | 203.00 ng/ml | — |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 108.85 ng/ml | Geometric Coefficient of Variation 49.5 |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 21 Day 1 | 169.00 ng/ml | — |
| Part 2B: BMS-986218 7 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 179.31 ng/ml | Geometric Coefficient of Variation 37.25 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 579.85 ng/ml | Geometric Coefficient of Variation 57.85 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 460.96 ng/ml | Geometric Coefficient of Variation 112.61 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 455.88 ng/ml | Geometric Coefficient of Variation 69.43 |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 9 Day 1 | 2030.00 ng/ml | — |
| Part 2B: BMS-986218 20 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 407.90 ng/ml | Geometric Coefficient of Variation 62.1 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 1473.97 ng/ml | Geometric Coefficient of Variation 45.56 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 9 Day 1 | 2110.00 ng/ml | — |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 1076.42 ng/ml | Geometric Coefficient of Variation 60.99 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 13 Day 1 | 1470.00 ng/ml | — |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 1462.14 ng/ml | Geometric Coefficient of Variation 44.11 |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 17 Day 1 | 1150.00 ng/ml | — |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 21 Day 1 | 715.00 ng/ml | — |
| Part 2B: BMS-986218 70 mg Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 1721.74 ng/ml | Geometric Coefficient of Variation 44.78 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 423.18 ng/ml | Geometric Coefficient of Variation 63.54 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 365.27 ng/ml | Geometric Coefficient of Variation 102.58 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 532.21 ng/ml | Geometric Coefficient of Variation 192.34 |
| Part 2C: BMS-986218 + Nivolumab Non-Small Cell Lung Cancer (NSCLC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 318.78 ng/ml | Geometric Coefficient of Variation 94.16 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 9 Day 1 | 646.00 ng/ml | — |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 2 Day 1 | 383.71 ng/ml | Geometric Coefficient of Variation 71.78 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 17 Day 1 | 1600.00 ng/ml | — |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 3 Day 1 | 346.90 ng/ml | Geometric Coefficient of Variation 55.72 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 13 Day 1 | 1820.00 ng/ml | — |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 5 Day 1 | 518.96 ng/ml | Geometric Coefficient of Variation 71.39 |
| Part 2D: BMS-986218 + Nivolumab Microsatellite Stable Colorectal Cancer (MSS CRC) | Trough Observed Plasma Concentration (Ctrough) for BMS-986218 | Cycle 4 Day 1 | 734.46 ng/ml | Geometric Coefficient of Variation 37.26 |