A Phase 1/2 interventional study of BMS-986205 and Nivolumab in Advanced Cancer, Melanoma and Non-Small Cell Lung Cancer, sponsored by Bristol-Myers Squibb. Completed at 47 sites in 11 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-08-28.
Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment
The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 627 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
BMS 986205 + Nivolumab specified dose at specified intervals.
Drug: BMS-986205 · Drug: Nivolumab
BMS 986205 + Nivolumab specified dose at specified intervals.
Drug: BMS-986205 · Drug: Nivolumab
BMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals
Drug: BMS-986205 · Drug: Nivolumab · Drug: Ipilimumab
Also known as: BMS-936558, ANTI-PD1
Also known as: BMS-734016, ANTI-CTLA-4
Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths
Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation and deaths.
Time frame: From first dose to 100 days after last dose (up to 15 months)
Number of Treated Participant With Laboratory Abnormalities - Thyroid
The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study. Free T3 (FT3) Free T4 (FT4) Thyroid stimulating hormone (TSH) Lower Limit of Normal (LLN) Upper limit of normal (ULN) Results reported in International System of Units (SI)
Time frame: From first dose to 100 days after last dose (up to 15 months)
Number of Treated Participant With Laboratory Abnormalities - Liver
The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study. Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Results reported in International System of Units (SI)
Time frame: From first dose to 100 days after last dose (up to 15 months)
Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3
Best overall response (BOR) is defined as the best response designation over the study as a whole. Complete response (CR) or partial response (PR) determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. For those participants who have surgical resection, only pre-surgical tumor assessments will be considered in the determination of BOR. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease. (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Appearance of 1 or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3
Objective response rate (ORR) is defined as the percentage of all treated participants whose BOR is either a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Time frame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Median Duration of Response (DoR) - Parts 2 and 3
Duration of response (DoR) was computed for all treated subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Time frame: From first dose to the date of disease progression, death, or until participants withdraw from the study, whichever occurs first (up to a maximum of 185 weeks)
Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 24 weeks. Reported values are estimates derived from Kaplan-Meier analyses.
Time frame: At 24 weeks after first dose
Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 1 year. Reported values are estimates derived from Kaplan-Meier analyses.
Time frame: At 1 year
Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 2 years. Reported values are estimates derived from Kaplan-Meier analyses.
Time frame: At 2 years
Cmax
Cmax is defined as the maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205.
Time frame: At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]
Tmax
Tmax is defined as the time of maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205.
Time frame: At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]
AUC(TAU)
AUC(TAU) is defined as the area under the concentration-time curve in 1 dosing interval. Pharmacokinetic parameters measured here are for BMS-986205.
Time frame: Cycle 0 Day 1 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 0 Day 14 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose)
Ctrough
Ctrough is defined as the trough observed plasma concentration at the end of the dosing interval.
Time frame: At cycles 0 [up to 2 weeks] and at cycles 3, 5, 7, 10, 11, 13, 15 [each cycle is up to 4 weeks]
CLT/F
CLT/F is defined as the apparent total body clearance. Pharmacokinetic parameters measured here are for BMS-986205.
Time frame: At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]
Accumulation Index (AI) - AUC(TAU)
Accumulation index (AI) of AUC(TAU) is calculated based on the ratio of AUC(TAU) at steady state to after the first dose. Pharmacokinetic parameters measured here are for BMS-986205.
Time frame: Cycle 0 Day 1 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 0 Day 14 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose)
Accumulation Index (AI) - Cmax
Accumulation index (AI) of Cmax is calculated based on the ratio of Cmax at steady state to after the first dose. Pharmacokinetic parameters measured here are for BMS-986205.
Time frame: At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]
Change From Baseline in Serum Kynurenine
Pharmacodynamics assessed by change from baseline in serum kynurenine. Changes in kynurenine expression were evaluated in serum samples from participants treated using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Kynurenine is an important metabolite of the IDO-1 Enzyme. Change in Kynurenine levels from baseline is an important indicator of BMS-986205 (IDO1 inhibitor) pharmacodynamic activity.
Time frame: At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks]
Percent Change From Baseline in Serum Kynurenine
Pharmacodynamics assessed by change from baseline in serum kynurenine. Changes in kynurenine expression were evaluated in serum samples from participants treated using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Kynurenine is an important metabolite of the IDO-1 Enzyme. Change in Kynurenine levels from baseline is an important indicator of BMS-986205 (IDO1 inhibitor) pharmacodynamic activity.
Time frame: At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks]
Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies
Best overall response (BOR) is defined as the best response designation over the study as a whole. Complete response (CR) or partial response (PR) determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. For those participants who have surgical resection, only pre-surgical tumor assessments will be considered in the determination of BOR. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease. (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Appearance of 1 or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies
Objective response rate (ORR) is defined as the percentage of all treated participants whose BOR is either a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. CR+PR confidence interval based on the Clopper and Pearson method.
Time frame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies
Duration of response (DoR) was computed for all treated subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Time frame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 24 weeks. Reported values are estimates derived from Kaplan-Meier analyses.
Time frame: At 24 weeks after first dose
Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 1 year. Reported values are estimates derived from Kaplan-Meier analyses.
Time frame: At 1 year
Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 2 years. Reported values are estimates derived from Kaplan-Meier analyses.
Time frame: At 2 years
Number of Participants With a Positive Anti-Drug Antibody (ADA) Test
A participant with at least one ADA-positive sample relative to baseline after initiation of treatment with nivolumab or ipilimumab. ADA-Positive after initiation of treatment was defined as (1) an ADA detected (positive seroconversion) sample in a subject for whom ADA is not detected at baseline, or (2) an ADA detected sample with ADA titer to be at least 4-fold or greater (≥) than baseline positive titer.
Time frame: From first dose to last dose (up to approximately 48 weeks)
| Milestone | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | Unplanned - BMS50 | Unplanned | QTc Substudy | Food Effect/ Relative BA (FE BA) Substudy |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 7 | 11 | 12 | 18 | 7 | 18 | 17 | 22 | 36 | 15 | 14 | 14 | 16 | 79 | 9 | 6 | 37 | 17 | 80 | 41 | 32 | 42 | 41 | 1 | 1 | 20 | 14 |
| Completed | 7 | 11 | 12 | 18 | 7 | 18 | 17 | 22 | 35 | 15 | 14 | 14 | 16 | 79 | 9 | 6 | 37 | 17 | 80 | 41 | 32 | 42 | 41 | 1 | 1 | 20 | 14 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Participant no longer meets study criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | Unplanned - BMS50 | Unplanned | QTc Substudy | Food Effect/ Relative BA (FE BA) Substudy |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 7 | 11 | 12 | 18 | 7 | 18 | 17 | 22 | 35 | 15 | 14 | 14 | 16 | 79 | 9 | 6 | 37 | 17 | 80 | 41 | 32 | 42 | 41 | 1 | 1 | 20 | 14 |
| Completed | 1 | 2 | 1 | 3 | 0 | 0 | 2 | 1 | 4 | 3 | 3 | 4 | 4 | 31 | 3 | 3 | 3 | 3 | 18 | 2 | 8 | 8 | 9 | 0 | 0 | 2 | 1 |
| Not completed | 6 | 9 | 11 | 15 | 7 | 18 | 15 | 21 | 31 | 12 | 11 | 10 | 12 | 48 | 6 | 3 | 34 | 14 | 62 | 39 | 24 | 34 | 32 | 1 | 1 | 18 | 13 |
| Withdrew: Adverse event | 0 | 1 | 2 | 2 | 1 | 0 | 0 | 2 | 1 | 2 | 3 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 5 | 1 | 3 | 0 | 5 | 0 | 0 | 2 | 1 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Maximum clinical benefit | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Non-compliance with study drug | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Other reasons | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Withdrew: Progressive disease | 6 | 7 | 6 | 12 | 6 | 18 | 12 | 19 | 26 | 8 | 7 | 9 | 8 | 29 | 6 | 2 | 32 | 14 | 40 | 32 | 19 | 30 | 15 | 0 | 0 | 14 | 11 |
| Withdrew: Study drug toxicity | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 1 | 2 | 9 | 0 | 1 | 1 | 0 | 8 | 3 | 2 | 0 | 8 | 0 | 0 | 2 | 0 |
| Withdrew: Participant no longer meets study criteria | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 3 | 0 | 0 | 1 | 0 | 4 | 3 | 0 | 4 | 1 | 1 | 0 | 0 | 0 |
Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation and deaths.
| Participants | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Unplanned - BMS50 | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | Unplanned |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Events | 1 | 1 | 0 | 7 | 10 | 11 | 18 | 6 | 18 | 17 | 21 | 34 | 15 | 14 | 14 | 16 | 79 | 8 | 6 | 35 | 17 | 80 | 39 | 31 | 41 | 41 | 1 |
| Serious Adverse Events | 1 | 1 | 0 | 5 | 6 | 8 | 12 | 5 | 15 | 14 | 18 | 27 | 12 | 9 | 12 | 11 | 42 | 8 | 1 | 18 | 10 | 50 | 32 | 22 | 22 | 22 | 1 |
| AEs Leading to Discontinuation | 0 | 1 | 0 | 1 | 1 | 4 | 4 | 0 | 2 | 0 | 7 | 6 | 3 | 4 | 2 | 6 | 16 | 1 | 1 | 3 | 4 | 15 | 6 | 7 | 3 | 1 | 0 |
| Deaths | 1 | 1 | 0 | 6 | 8 | 9 | 15 | 4 | 16 | 12 | 21 | 21 | 11 | 12 | 9 | 12 | 34 | 6 | 2 | 26 | 12 | 59 | 34 | 22 | 19 | 16 | 0 |
The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study. Free T3 (FT3) Free T4 (FT4) Thyroid stimulating hormone (TSH) Lower Limit of Normal (LLN) Upper limit of normal (ULN) Results reported in International System of Units (SI)
| Participants | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Unplanned - BMS50 | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | Unplanned |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TSH > ULN | 0 | 0 | 0 | 1 | 1 | 2 | 2 | 3 | 4 | 7 | 1 | 2 | 6 | 6 | 3 | 4 | 19 | 1 | 1 | 5 | 4 | 16 | 4 | 9 | 17 | 15 | 0 |
| TSH > ULN with TSH ≤ ULN at baseline | 0 | 0 | 0 | 1 | 1 | 1 | 2 | 2 | 1 | 7 | 1 | 2 | 4 | 4 | 3 | 3 | 17 | 1 | 1 | 1 | 1 | 13 | 1 | 8 | 10 | 12 | 0 |
| TSH > ULN with at least one FT3/FT4 test value < LLN | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 2 | 5 | 1 | 1 | 4 | 2 | 2 | 3 | 15 | 0 | 0 | 3 | 1 | 5 | 1 | 7 | 9 | 4 | 0 |
| TSH < LLN | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 1 | 1 | 2 | 2 | 2 | 2 | 3 | 3 | 2 | 17 | 2 | 1 | 3 | 5 | 25 | 4 | 8 | 9 | 10 | 1 |
| TSH < LLN with TSH ≥ LLN at baseline | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 1 | 2 | 2 | 2 | 1 | 0 | 3 | 2 | 15 | 2 | 1 | 3 | 4 | 19 | 3 | 7 | 7 | 8 | 1 |
| TSH < LLN with at least one FT3/FT4 test value > ULN | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 5 | 1 | 0 | 1 | 1 | 7 | 0 | 3 | 4 | 4 | 1 |
The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study. Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Results reported in International System of Units (SI)
| Participants | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Unplanned - BMS50 | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | Unplanned |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALT or AST > 3X ULN | 0 | 1 | 0 | 2 | 1 | 1 | 7 | 3 | 1 | 6 | 6 | 5 | 1 | 2 | 3 | 5 | 21 | 2 | 0 | 4 | 2 | 15 | 4 | 7 | 4 | 15 | 1 |
| ALT or AST > 5X ULN | 0 | 0 | 0 | 0 | 0 | 1 | 5 | 2 | 1 | 1 | 4 | 4 | 0 | 2 | 2 | 4 | 16 | 2 | 0 | 4 | 1 | 10 | 4 | 5 | 2 | 12 | 0 |
| ALT or AST > 10X ULN | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 3 | 7 | 0 | 0 | 3 | 0 | 8 | 2 | 1 | 1 | 4 | 0 |
| ALT or AST > 20X ULN | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 5 | 0 | 0 | 1 | 0 | 3 | 1 | 0 | 1 | 2 | 0 |
| Total Bilirubin > 2X ULN | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 2 | 0 | 1 | 1 | 3 | 4 | 1 | 0 | 1 | 2 | 2 | 2 | 1 | 1 | 0 | 0 |
| Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 3 | 3 | 1 | 0 | 1 | 2 | 2 | 1 | 1 | 0 | 0 | 0 |
| Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 3 | 3 | 1 | 0 | 1 | 2 | 2 | 2 | 1 | 0 | 0 | 0 |
Best overall response (BOR) is defined as the best response designation over the study as a whole. Complete response (CR) or partial response (PR) determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. For those participants who have surgical resection, only pre-surgical tumor assessments will be considered in the determination of BOR. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease. (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Appearance of 1 or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
| Participants | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Complete response (CR) | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 15 | 3 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 5 |
| Partial response (PR) | 0 | 4 | 1 | 5 | 2 | 3 | 5 | 3 | 17 | 1 | 1 | 1 | 2 | 12 | 4 | 3 | 8 | 12 |
| Stable disease (SD) | 6 | 8 | 1 | 5 | 6 | 4 | 0 | 4 | 14 | 2 | 1 | 11 | 3 | 28 | 14 | 10 | 13 | 11 |
| Progressive disease (PD) | 10 | 3 | 17 | 20 | 3 | 2 | 8 | 6 | 29 | 3 | 2 | 23 | 9 | 28 | 21 | 15 | 17 | 9 |
| Unable to determine (UTD) | 2 | 2 | 3 | 5 | 4 | 4 | 0 | 1 | 4 | 0 | 0 | 2 | 3 | 10 | 2 | 4 | 4 | 4 |
Objective response rate (ORR) is defined as the percentage of all treated participants whose BOR is either a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
| Percentage of participants | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 0 (0.0 to 18.5) | 23.5 (6.8 to 49.9) | 4.5 (0.1 to 22.8) | 14.3 (4.8 to 30.3) | 13.3 (1.7 to 40.5) | 28.6 (8.4 to 58.1) | 42.9 (17.7 to 71.1) | 31.3 (11.0 to 58.7) | 40.5 (29.6 to 52.1) | 44.4 (13.7 to 78.8) | 50.0 (11.8 to 88.2) | 2.7 (0.1 to 14.2) | 11.8 (1.5 to 36.4) | 17.5 (9.9 to 27.6) | 9.8 (2.7 to 23.1) | 9.4 (2.0 to 25.0) | 19 (8.6 to 34.1) | 41.5 (26.3 to 57.9) |
Duration of response (DoR) was computed for all treated subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
| Weeks | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Median Duration of Response (DoR) - Parts 2 and 3 | — | 134.14 (12.71 to NA) | NA (NA to NA) | 42.57 (13.29 to NA) | NA (40.14 to NA) | 76.14 (16 to NA) | NA (16.14 to NA) | NA (35.86 to NA) | 144.14 (84.57 to NA) | NA (24 to NA) | NA (NA to NA) | NA (NA to NA) | 55.14 (39.14 to NA) | 51.79 (26.43 to NA) | 32.14 (17.29 to NA) | NA (64.43 to NA) | 32.07 (16 to 98.14) | NA (67.14 to NA) |
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 24 weeks. Reported values are estimates derived from Kaplan-Meier analyses.
| Percentage of participants | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 6.6 (0.4 to 25.8) | 38.0 (15.7 to 60.3) | 4.5 (0.3 to 18.9) | 24.2 (11.4 to 39.6) | 20.0 (4.9 to 42.4) | 42.9 (17.7 to 66.0) | 42.9 (17.7 to 66.0) | 37.5 (15.4 to 59.8) | 48.2 (36.5 to 58.9) | 53.3 (17.7 to 79.6) | 50 (11.1 to 80.4) | 15.1 (5.6 to 29) | 17.6 (4.3 to 38.3) | 37.3 (26.6 to 48) | 23.7 (11.8 to 37.9) | 36.4 (19.8 to 53.2) | 34.8 (20.5 to 49.5) | 56 (39 to 69.9) |
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 1 year. Reported values are estimates derived from Kaplan-Meier analyses.
| Percentage of participants | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | NA (NA to NA) | 19.0 (4.7 to 40.6) | 4.5 (0.3 to 18.9) | 8.1 (1.7 to 21.2) | 13.3 (2.2 to 34.6) | 34.3 (11.6 to 58.7) | 28.6 (8.8 to 52.4) | 31.3 (11.4 to 53.6) | 39.8 (28.7 to 50.7) | 26.7 (4.1 to 57.9) | 50 (11.1 to 80.4) | 6 (1.1 to 17.5) | 11.8 (2 to 31.2) | 20.9 (12.5 to 30.7) | 5.3 (1 to 15.5) | 20.2 (7.7 to 36.9) | 10.7 (3.4 to 22.8) | 47.3 (30.7 to 62.1) |
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 2 years. Reported values are estimates derived from Kaplan-Meier analyses.
| Percentage of participants | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | NA (NA to NA) | 12.7 (2.1 to 33.1) | 4.5 (0.3 to 18.9) | 4.0 (0.3 to 16.4) | 6.7 (0.4 to 26.0) | 8.6 (0.5 to 31.5) | 21.4 (5.2 to 44.8) | 25.0 (7.8 to 47.2) | 34.0 (23.4 to 44.9) | 26.7 (4.1 to 57.9) | 50 (11.1 to 80.4) | 6 (1.1 to 17.5) | 11.8 (2 to 31.2) | 8.3 (3.4 to 16.1) | 2.6 (0.2 to 11.8) | 12.1 (3.2 to 27.5) | 5.4 (1 to 15.7) | 31.8 (16.2 to 48.7) |
Cmax is defined as the maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205.
| ng/mL | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) |
|---|---|---|---|---|---|
| Cycle 0, Day 1 | 94.884 ± 43 | 148.975 ± 69 | 349.767 ± 57 | 613.202 ± 60 | 1248.062 ± 107 |
| Cycle 0, Day 14 | 152.082 ± 33 | 220.196 ± 44 | 475.745 ± 32 | 1091.549 ± 50 | 1912.682 ± 61 |
Tmax is defined as the time of maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205.
| hours | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) |
|---|---|---|---|---|---|
| Cycle 0, Day 1 | 3.050 (2.95 to 6) | 3 (2.07 to 8.15) | 4.025 (1.08 to 8.08) | 4.009 (2 to 7.92) | 4.300 (2.08 to 24.58) |
| Cycle 0, Day 14 | 3 (1.95 to 3.12) | 4 (2 to 6.12) | 3.025 (2 to 8.13) | 3.017 (1 to 8) | 3 (2.05 to 28.45) |
AUC(TAU) is defined as the area under the concentration-time curve in 1 dosing interval. Pharmacokinetic parameters measured here are for BMS-986205.
| h*ng/mL | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) |
|---|---|---|---|---|---|
| Cycle 0, Day 1 | 700.886 ± 30 | 1125.546 ± 54 | 2271.901 ± 53 | 5091.460 ± 53 | 10479.864 ± 73 |
| Cycle 0, Day 14 | 2079.137 ± 23 | 2531.139 ± 65 | 4949.909 ± 54 | 13073.275 ± 41 | 19473.051 ± 46 |
Ctrough is defined as the trough observed plasma concentration at the end of the dosing interval.
| ng/mL | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Unplanned - BMS50 | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | QTc Substudy | Food Effect/ Relative BA (FE BA) Substudy | Unplanned |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 0, Day 2 | — | — | — | 12.020 ± 37 | 22.216 ± 64 | 33.918 ± 82 | 90.605 ± 61 | 225.065 ± 60 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Cycle 0, Day 8 | — | — | — | 53.307 ± 110 | 100.238 ± 76 | 86.651 ± 155 | 322.492 ± 38 | 582.580 ± 83 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 10.021 ± 106 | — |
| Cycle 0, Day 14 | — | — | — | 53.522 ± 50 | 65.590 ± 100 | 112.154 ± 84 | 332.165 ± 66 | 373.479 ± 213 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Cycle 3, Day 1 | — | — | — | 38.862 ± 91 | 76.193 ± 1 | 190.984 ± 79 | 374.882 ± 86 | 255.592 ± NA | 281.639 ± 83 | 394.303 ± 42 | — | 140.834 ± 62 | 139.560 ± 79 | 240.978 ± 87 | 121.641 ± 52 | 252.083 ± 8 | 121.650 ± 72 | 200.303 ± 29 | — | 127.464 ± 144 | 82.588 ± 202 | 126.298 ± 60 | 86.613 ± 1021 | 145.265 ± 46 | 114.018 ± 72 | — | — | 137.123 ± 71 | — |
| Cycle 5, Day 1 | — | — | — | 52.371 ± 19 | 23.974 ± 305 | 412.812 ± NA | 251.690 ± 79 | — | 147 ± NA | 375.415 ± 47 | 39.556 ± 37 | 183.272 ± 69 | 133.796 ± 99 | 201.574 ± 63 | 169.231 ± 114 | 251.110 ± 23 | 110.097 ± 63 | 263.717 ± 91 | — | 96.255 ± 162 | 106.315 ± 57 | 149.506 ± 55 | 167.949 ± 21 | 188.233 ± 50 | 105.164 ± 107 | — | — | 78.595 ± 101 | — |
| Cycle 7, Day 1 | — | — | — | — | — | — | 573.328 ± 59 | — | — | — | 41.3 ± NA | 144.312 ± 30 | 246.552 ± 45 | — | — | — | 120.596 ± 79 | — | — | 35.608 ± 443 | — | 103.057 ± 64 | 149 ± NA | 84.598 ± 168 | 117.556 ± 43 | — | — | 161.750 ± 95 | — |
| Cycle 10, Day 1 | — | — | — | — | — | — | 390 ± NA | — | — | 397.233 ± 15 | 55.7 ± NA | — | 65.1 ± NA | — | 305.405 ± 22 | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Cycle 11, Day 1 | — | — | — | — | — | — | 427 ± NA | — | — | 350 ± NA | — | 95.121 ± 65 | — | — | — | — | 150.150 ± 80 | 237.382 ± 45 | — | 160.792 ± 21 | — | 137.222 ± 76 | — | — | — | — | — | — | — |
| Cycle 13, Day 1 | — | — | — | — | — | — | — | — | — | — | — | — | 55 ± NA | — | 53.072 ± 29 | — | 372 ± NA | 336 ± NA | — | — | — | 129 ± NA | — | 411 ± NA | — | — | — | — | — |
| Cycle 15, Day 1 | — | — | — | — | — | — | 1650 ± NA | — | — | — | — | 84.014 ± 77 | — | 287 ± NA | 104.517 ± 318 | 171 ± NA | 109.168 ± 63 | — | — | 11.2 ± NA | — | 104.957 ± 38 | — | — | — | — | — | — | — |
CLT/F is defined as the apparent total body clearance. Pharmacokinetic parameters measured here are for BMS-986205.
| L/h | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) |
|---|---|---|---|---|---|
| CLT/F | 12.024 ± 23 | 19.754 ± 65 | 20.202 ± 54 | 15.298 ± 41 | 20.541 ± 46 |
Accumulation index (AI) of AUC(TAU) is calculated based on the ratio of AUC(TAU) at steady state to after the first dose. Pharmacokinetic parameters measured here are for BMS-986205.
| Ratio | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) |
|---|---|---|---|---|---|
| Accumulation Index (AI) - AUC(TAU) | 2.966 ± 20 | 2.380 ± 67 | 2.290 ± 63 | 2.360 ± 43 | 1.9 ± 49 |
Accumulation index (AI) of Cmax is calculated based on the ratio of Cmax at steady state to after the first dose. Pharmacokinetic parameters measured here are for BMS-986205.
| Ratio | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) |
|---|---|---|---|---|---|
| Accumulation Index (AI) - Cmax | 1.603 ± 45 | 1.523 ± 55 | 1.360 ± 66 | 1.646 ± 59 | 1.505 ± 52 |
Pharmacodynamics assessed by change from baseline in serum kynurenine. Changes in kynurenine expression were evaluated in serum samples from participants treated using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Kynurenine is an important metabolite of the IDO-1 Enzyme. Change in Kynurenine levels from baseline is an important indicator of BMS-986205 (IDO1 inhibitor) pharmacodynamic activity.
| microMolars | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Unplanned - BMS50 | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | Unplanned |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Change From Baseline in Serum Kynurenine | — | — | — | -208.7 ± 112 | -262 ± 111.2 | -369.7 ± 200.8 | -314 ± 243.3 | -326.4 ± 193.8 | -378.1 ± 241.1 | -361.9 ± 153.3 | -278.6 ± 214.4 | -391 ± 230.1 | -281.9 ± 144.1 | -495.1 ± 281.6 | -331.5 ± 199.1 | -398.9 ± 155.5 | -371.8 ± 171.5 | -386.4 ± 109 | 124.4 ± 141.3 | -399 ± 161 | -325.4 ± 117.6 | -360.7 ± 162.3 | -487.2 ± 193 | -317.8 ± 134.7 | -427.4 ± 156.4 | — | — |
Pharmacodynamics assessed by change from baseline in serum kynurenine. Changes in kynurenine expression were evaluated in serum samples from participants treated using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Kynurenine is an important metabolite of the IDO-1 Enzyme. Change in Kynurenine levels from baseline is an important indicator of BMS-986205 (IDO1 inhibitor) pharmacodynamic activity.
| Percent change | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Unplanned - BMS50 | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | Unplanned |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percent Change From Baseline in Serum Kynurenine | — | — | — | -37.7 ± 14.1 | -46.6 ± 16.1 | -56.4 ± 14.9 | -44.7 ± 31.1 | -44.1 ± 23.6 | -54 ± 22.1 | -61 ± 9.6 | -46.9 ± 15.8 | -53.2 ± 20.4 | -49.4 ± 24.8 | -57 ± 22.3 | -49.3 ± 20.3 | -56.5 ± 15.2 | -57.8 ± 13.2 | -57.9 ± 15.6 | 24.7 ± 23.8 | -61.3 ± 12.8 | -56.5 ± 11.9 | -55.2 ± 14.2 | -61.5 ± 11.8 | -50.8 ± 17.6 | -55.3 ± 11.2 | — | — |
Best overall response (BOR) is defined as the best response designation over the study as a whole. Complete response (CR) or partial response (PR) determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. For those participants who have surgical resection, only pre-surgical tumor assessments will be considered in the determination of BOR. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease. (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Appearance of 1 or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
| Participants | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Food Effect/ Relative BA (FE BA) Substudy | QTc Substudy |
|---|---|---|---|---|---|---|---|---|---|
| Complete response (CR) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Partial response (PR) | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 1 |
| Stable disease (SD) | 0 | 0 | 2 | 3 | 4 | 4 | 2 | 3 | 2 |
| Progressive disease (PD) | 0 | 0 | 5 | 5 | 7 | 9 | 4 | 7 | 14 |
| Unable to determine (UTD) | 1 | 1 | 0 | 1 | 1 | 4 | 0 | 2 | 3 |
Objective response rate (ORR) is defined as the percentage of all treated participants whose BOR is either a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. CR+PR confidence interval based on the Clopper and Pearson method.
| Percentage of participants | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Food Effect/ Relative BA (FE BA) Substudy | QTc Substudy |
|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies | 0 (0 to 97.5) | 0 (0 to 97.5) | 0 (0 to 41.0) | 10 (0.3 to 44.5) | 0 (0 to 26.5) | 5.6 (0.1 to 27.3) | 0 (0 to 45.9) | 14.3 (1.8 to 42.8) | 5 (0.1 to 24.9) |
Duration of response (DoR) was computed for all treated subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
| Weeks | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Food Effect/ Relative BA (FE BA) Substudy | QTc Substudy |
|---|---|---|---|---|---|---|---|---|---|
| Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies | — | — | — | 52.14 (NA to NA) | — | NA (NA to NA) | — | NA (24.29 to NA) | NA (NA to NA) |
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 24 weeks. Reported values are estimates derived from Kaplan-Meier analyses.
| Percentage of participants | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Food Effect/ Relative BA (FE BA) Substudy | QTc Substudy |
|---|---|---|---|---|---|---|---|---|---|
| Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies | NA (NA to NA) | NA (NA to NA) | 14.3 (0.7 to 46.5) | 30.0 (7.1 to 57.8) | 30.7 (7.3 to 58.6) | 28.2 (9.6 to 50.5) | NA (NA to NA) | 35.7 (13 to 59.4) | 10.5 (1.8 to 28.4) |
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 1 year. Reported values are estimates derived from Kaplan-Meier analyses.
| Percentage of participants | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Food Effect/ Relative BA (FE BA) Substudy | QTc Substudy |
|---|---|---|---|---|---|---|---|---|---|
| Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 15 (1 to 45.7) | NA (NA to NA) | 21.2 (5.6 to 43.4) | NA (NA to NA) | 14.3 (2.3 to 36.6) | 10.5 (1.8 to 28.4) |
Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 2 years. Reported values are estimates derived from Kaplan-Meier analyses.
| Percentage of participants | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Food Effect/ Relative BA (FE BA) Substudy | QTc Substudy |
|---|---|---|---|---|---|---|---|---|---|
| Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies | NA | NA | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 7.1 (0.5 to 27) | NA (NA to NA) | 7.1 (0.5 to 27.5) | 5.3 (0.4 to 21.4) |
A participant with at least one ADA-positive sample relative to baseline after initiation of treatment with nivolumab or ipilimumab. ADA-Positive after initiation of treatment was defined as (1) an ADA detected (positive seroconversion) sample in a subject for whom ADA is not detected at baseline, or (2) an ADA detected sample with ADA titer to be at least 4-fold or greater (≥) than baseline positive titer.
| Participants | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Unplanned - BMS50 | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | Unplanned |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nivolumab ADA+ | — | — | — | 1 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 0 | 0 | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 6 | 0 | 1 | 3 | 2 | — |
| Ipilimumab ADA+ | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 1 | — |
Collected over Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 5 years and 8 months). SAEs and other AEs were assessed from first dose to 100 days following last dose (up to approximately 15 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: BMS50 (ESC) | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| Part 1: BMS400 (ESC) | 1/1 (100%) | 1/1 (100%) | 0/1 (0%) |
| Unplanned - BMS50 | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Part 1: BMS25+NIV240(ESC) | 6/7 (85.7%) | 5/7 (71.4%) | 7/7 (100%) |
| Part 1: BMS50+NIV240(ESC) | 8/10 (80%) | 6/10 (60%) | 10/10 (100%) |
| Part 1: BMS100+NIV240(ESC) | 9/12 (75%) | 8/12 (66.7%) | 12/12 (100%) |
| Part 1: BMS200+NIV240(ESC) | 15/18 (83.3%) | 12/18 (66.7%) | 18/18 (100%) |
| Part 1: BMS400+NIV240(ESC | 4/6 (66.7%) | 5/6 (83.3%) | 6/6 (100%) |
| Part 2: Exp Cervical + (IDO 100) | 16/18 (88.9%) | 15/18 (83.3%) | 18/18 (100%) |
| Part 2: Exp Cervical + (IDO 200) | 12/17 (70.6%) | 14/17 (82.4%) | 17/17 (100%) |
| Part 2: Exp Pancreatic | 21/22 (95.5%) | 18/22 (81.8%) | 20/22 (90.9%) |
| Part 2: Exp DLBCL | 21/35 (60%) | 27/35 (77.1%) | 29/35 (82.9%) |
| Part 2: Exp SCCHN + (IDO 100) | 12/15 (80%) | 12/15 (80%) | 13/15 (86.7%) |
| Part 2: Exp SCCHN + (IDO 200) | 12/14 (85.7%) | 9/14 (64.3%) | 14/14 (100%) |
| Part 2: Exp Bladder + (IDO 100) | 9/14 (64.3%) | 12/14 (85.7%) | 14/14 (100%) |
| Part 2: Exp Bladder + (IDO 200) | 12/16 (75%) | 11/16 (68.8%) | 15/16 (93.8%) |
| Part 2: Exp ML I-O Naive | 34/79 (43%) | 42/79 (53.2%) | 78/79 (98.7%) |
| Part 2: Exp ML BRAF-MT | 6/9 (66.7%) | 8/9 (88.9%) | 8/9 (88.9%) |
| Part 2: Exp ML BRAF-MT- NIVO | 2/6 (33.3%) | 1/6 (16.7%) | 6/6 (100%) |
| Part 2: Exp ML Anti-PDL1 | 26/37 (70.3%) | 18/37 (48.6%) | 35/37 (94.6%) |
| Part 2: Exp ML Anti-PDL1+CTLA4 | 12/17 (70.6%) | 10/17 (58.8%) | 17/17 (100%) |
| Part 2: Exp NSCLC I-O Naive | 59/80 (73.8%) | 50/80 (62.5%) | 78/80 (97.5%) |
| Part 2: Exp NSCLC Anti-PDL1 | 34/41 (82.9%) | 32/41 (78%) | 38/41 (92.7%) |
| Part 2: Exp ASST | 22/32 (68.8%) | 22/32 (68.8%) | 30/32 (93.8%) |
| Part 2: Exp Renal | 19/42 (45.2%) | 22/42 (52.4%) | 40/42 (95.2%) |
| Part 3: Melanoma | 7/26 (26.9%) | 9/26 (34.6%) | 26/26 (100%) |
| Part 3: NSCLC | 9/15 (60%) | 13/15 (86.7%) | 14/15 (93.3%) |
| Unplanned | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Food Effect/ Relative BA (FE BA) Substudy | 9/14 (64.3%) | 7/14 (50%) | 13/14 (92.9%) |
| QTc Substudy | 14/20 (70%) | 14/20 (70%) | 19/20 (95%) |
| Event | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Unplanned - BMS50 | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma | Part 3: NSCLC | Unplanned | Food Effect/ Relative BA (FE BA) Substudy | QTc Substudy |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Jaundice cholestaticHepatobiliary disorders | 0/1 | 1/1 | 0/1 | 0/7 | 0/10 | 0/12 | 0/18 | 0/6 | 0/18 | 0/17 | 0/22 | 0/35 | 0/15 | 0/14 | 0/14 | 0/16 | 0/79 | 0/9 | 0/6 | 0/37 | 0/17 | 0/80 | 0/41 | 0/32 | 0/42 | 0/26 | 0/15 | 0/1 | 0/14 | 0/20 |
| Urinary tract infectionInfections and infestations | 1/1 | 0/1 | 0/1 | 0/7 | 0/10 | 0/12 | 1/18 | 0/6 | 0/18 | 2/17 | 0/22 | 0/35 | 0/15 | 0/14 | 1/14 | 0/16 | 1/79 | 0/9 | 0/6 | 0/37 | 0/17 | 2/80 | 0/41 | 0/32 | 0/42 | 0/26 | 0/15 | 0/1 | 0/14 | 0/20 |
| Transaminases increasedInvestigations | 0/1 | 0/1 | 0/1 | 0/7 | 0/10 | 0/12 | 0/18 | 0/6 | 0/18 | 0/17 | 0/22 | 0/35 | 0/15 | 0/14 | 0/14 | 0/16 | 1/79 | 1/9 | 0/6 | 0/37 | 0/17 | 0/80 | 0/41 | 0/32 | 0/42 | 0/26 | 0/15 | 1/1 | 0/14 | 0/20 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1 | 0/1 | 0/1 | 3/7 | 5/10 | 4/12 | 6/18 | 2/6 | 8/18 | 2/17 | 15/22 | 11/35 | 6/15 | 3/14 | 4/14 | 8/16 | 11/79 | 3/9 | 0/6 | 7/37 | 5/17 | 22/80 | 15/41 | 10/32 | 4/42 | 3/26 | 2/15 | 0/1 | 3/14 | 8/20 |
| Acute kidney injuryRenal and urinary disorders | 1/1 | 0/1 | 0/1 | 0/7 | 0/10 | 0/12 | 0/18 | 0/6 | 0/18 | 0/17 | 0/22 | 0/35 | 0/15 | 0/14 | 0/14 | 0/16 | 1/79 | 0/9 | 0/6 | 0/37 | 0/17 | 0/80 | 0/41 | 0/32 | 1/42 | 0/26 | 0/15 | 0/1 | 0/14 | 0/20 |
| HaematuriaRenal and urinary disorders | 1/1 | 0/1 | 0/1 | 0/7 | 0/10 | 0/12 | 0/18 | 0/6 | 1/18 | 0/17 | 0/22 | 0/35 | 0/15 | 0/14 | 1/14 | 0/16 | 0/79 | 0/9 | 0/6 | 0/37 | 0/17 | 0/80 | 0/41 | 0/32 | 0/42 | 0/26 | 0/15 | 0/1 | 0/14 | 0/20 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/1 | 0/1 | 0/1 | 0/7 | 0/10 | 0/12 | 0/18 | 0/6 | 1/18 | 0/17 | 0/22 | 0/35 | 0/15 | 0/14 | 0/14 | 0/16 | 1/79 | 0/9 | 0/6 | 0/37 | 0/17 | 1/80 | 1/41 | 0/32 | 1/42 | 0/26 | 0/15 | 0/1 | 1/14 | 0/20 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/1 | 0/1 | 0/1 | 0/7 | 0/10 | 0/12 | 1/18 | 0/6 | 0/18 | 2/17 | 0/22 | 2/35 | 0/15 | 2/14 | 1/14 | 1/16 | 0/79 | 1/9 | 0/6 | 0/37 | 0/17 | 5/80 | 5/41 | 4/32 | 2/42 | 0/26 | 4/15 | 0/1 | 1/14 | 0/20 |
| PneumoniaInfections and infestations | 0/1 | 0/1 | 0/1 | 0/7 | 1/10 | 0/12 | 1/18 | 0/6 | 0/18 | 1/17 | 0/22 | 2/35 | 3/15 | 1/14 | 0/14 | 0/16 | 1/79 | 0/9 | 0/6 | 1/37 | 0/17 | 7/80 | 3/41 | 0/32 | 2/42 | 0/26 | 1/15 | 0/1 | 0/14 | 0/20 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/1 | 0/1 | 0/1 | 0/7 | 0/10 | 0/12 | 1/18 | 0/6 | 0/18 | 0/17 | 2/22 | 0/35 | 0/15 | 1/14 | 0/14 | 0/16 | 2/79 | 0/9 | 0/6 | 0/37 | 0/17 | 2/80 | 7/41 | 1/32 | 2/42 | 0/26 | 0/15 | 0/1 | 0/14 | 2/20 |
| Event | Part 1: BMS50 (ESC) | Part 1: BMS400 (ESC) | Unplanned - BMS50 | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma | Part 3: NSCLC | Unplanned | Food Effect/ Relative BA (FE BA) Substudy | QTc Substudy |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ThyroiditisEndocrine disorders | 0/1 | 0/1 | 0/1 | 0/7 | 0/10 | 0/12 | 0/18 | 0/6 | 0/18 | 0/17 | 0/22 | 0/35 | 0/15 | 0/14 | 0/14 | 1/16 | 0/79 | 0/9 | 0/6 | 0/37 | 0/17 | 0/80 | 0/41 | 0/32 | 0/42 | 1/26 | 0/15 | 1/1 | 0/14 | 0/20 |
| DiplopiaEye disorders | 0/1 | 0/1 | 0/1 | 0/7 | 0/10 | 0/12 | 1/18 | 0/6 | 1/18 | 0/17 | 0/22 | 0/35 | 0/15 | 0/14 | 0/14 | 0/16 | 2/79 | 0/9 | 0/6 | 0/37 | 0/17 | 0/80 | 0/41 | 0/32 | 0/42 | 0/26 | 0/15 | 1/1 | 0/14 | 0/20 |
| Anal fissureGastrointestinal disorders | 0/1 | 0/1 | 0/1 | 0/7 | 0/10 | 0/12 | 0/18 | 0/6 | 0/18 | 0/17 | 0/22 | 0/35 | 0/15 | 0/14 | 0/14 | 0/16 | 0/79 | 0/9 | 0/6 | 0/37 | 0/17 | 0/80 | 0/41 | 0/32 | 0/42 | 0/26 | 0/15 | 1/1 | 0/14 | 0/20 |
| DysphagiaGastrointestinal disorders | 0/1 | 0/1 | 0/1 | 1/7 | 0/10 | 0/12 | 0/18 | 1/6 | 1/18 | 0/17 | 0/22 | 0/35 | 2/15 | 3/14 | 0/14 | 0/16 | 2/79 | 0/9 | 0/6 | 2/37 | 0/17 | 1/80 | 2/41 | 1/32 | 0/42 | 0/26 | 0/15 | 1/1 | 0/14 | 1/20 |
| NauseaGastrointestinal disorders | 0/1 | 0/1 | 0/1 | 4/7 | 3/10 | 6/12 | 8/18 | 3/6 | 9/18 | 3/17 | 9/22 | 10/35 | 3/15 | 4/14 | 4/14 | 7/16 | 32/79 | 3/9 | 1/6 | 10/37 | 5/17 | 24/80 | 7/41 | 16/32 | 18/42 | 11/26 | 5/15 | 1/1 | 6/14 | 9/20 |
| VomitingGastrointestinal disorders | 1/1 | 0/1 | 0/1 | 4/7 | 6/10 | 6/12 | 8/18 | 4/6 | 7/18 | 3/17 | 6/22 | 2/35 | 3/15 | 4/14 | 2/14 | 2/16 | 16/79 | 2/9 | 0/6 | 2/37 | 3/17 | 19/80 | 4/41 | 9/32 | 11/42 | 3/26 | 4/15 | 0/1 | 1/14 | 4/20 |
| ChillsGeneral disorders | 0/1 | 0/1 | 0/1 | 1/7 | 0/10 | 2/12 | 2/18 | 0/6 | 0/18 | 2/17 | 0/22 | 1/35 | 1/15 | 0/14 | 1/14 | 1/16 | 6/79 | 0/9 | 1/6 | 0/37 | 1/17 | 4/80 | 0/41 | 2/32 | 2/42 | 0/26 | 0/15 | 1/1 | 0/14 | 0/20 |
| Oedema peripheralGeneral disorders | 1/1 | 0/1 | 0/1 | 1/7 | 1/10 | 1/12 | 4/18 | 0/6 | 0/18 | 1/17 | 3/22 | 1/35 | 1/15 | 3/14 | 1/14 | 2/16 | 5/79 | 2/9 | 0/6 | 2/37 | 0/17 | 7/80 | 3/41 | 7/32 | 7/42 | 3/26 | 0/15 | 0/1 | 0/14 | 0/20 |
| Performance status decreasedGeneral disorders | 0/1 | 0/1 | 0/1 | 0/7 | 0/10 | 0/12 | 0/18 | 0/6 | 0/18 | 0/17 | 0/22 | 0/35 | 0/15 | 0/14 | 0/14 | 0/16 | 0/79 | 0/9 | 0/6 | 0/37 | 0/17 | 0/80 | 0/41 | 0/32 | 0/42 | 0/26 | 0/15 | 1/1 | 0/14 | 0/20 |
| HepatotoxicityHepatobiliary disorders | 0/1 | 0/1 | 0/1 | 0/7 | 0/10 | 0/12 | 0/18 | 0/6 | 0/18 | 0/17 | 0/22 | 0/35 | 0/15 | 0/14 | 0/14 | 1/16 | 1/79 | 0/9 | 0/6 | 0/37 | 0/17 | 0/80 | 0/41 | 0/32 | 1/42 | 0/26 | 0/15 | 1/1 | 0/14 | 0/20 |
| Age, Customized(Participants) | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | Unplanned - BMS50 | Unplanned | QTc Substudy | Food Effect/ Relative BA (FE BA) Substudy | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >= 18 to < 65 years | 5 | 8 | 9 | 13 | 5 | 16 | 15 | 13 | 15 | 9 | 7 | 6 | 7 | 41 | 6 | 4 | 20 | 10 | 52 | 20 | 19 | 23 | 26 | 1 | 0 | 11 | 10 | 371 |
| >= 65 to < 85 years | 2 | 3 | 3 | 5 | 2 | 2 | 2 | 9 | 21 | 6 | 7 | 8 | 9 | 37 | 3 | 2 | 16 | 7 | 28 | 21 | 13 | 18 | 15 | 0 | 1 | 9 | 4 | 253 |
| >= 85 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 3 |
| Sex: Female, Male(Participants) | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | Unplanned - BMS50 | Unplanned | QTc Substudy | Food Effect/ Relative BA (FE BA) Substudy | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 6 | 6 | 9 | 10 | 4 | 18 | 17 | 7 | 12 | 3 | 2 | 2 | 3 | 26 | 3 | 2 | 14 | 6 | 27 | 17 | 27 | 8 | 12 | 0 | 1 | 16 | 9 | 267 |
| Male | 1 | 5 | 3 | 8 | 3 | 0 | 0 | 15 | 24 | 12 | 12 | 12 | 13 | 53 | 6 | 4 | 23 | 11 | 53 | 24 | 5 | 34 | 29 | 1 | 0 | 4 | 5 | 360 |
| Ethnicity (NIH/OMB)(Participants) | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | Unplanned - BMS50 | Unplanned | QTc Substudy | Food Effect/ Relative BA (FE BA) Substudy | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 3 | 1 | 0 | 1 | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 18 |
| Not Hispanic or Latino | 4 | 7 | 7 | 10 | 4 | 8 | 8 | 7 | 4 | 2 | 8 | 3 | 6 | 43 | 3 | 5 | 16 | 5 | 38 | 15 | 17 | 21 | 32 | 0 | 0 | 15 | 14 | 302 |
| Unknown or Not Reported | 3 | 3 | 5 | 8 | 3 | 9 | 9 | 12 | 31 | 13 | 5 | 9 | 8 | 34 | 6 | 1 | 21 | 12 | 42 | 25 | 15 | 18 | 8 | 1 | 1 | 5 | 0 | 307 |
| Race (NIH/OMB)(Participants) | Part 1: BMS25+NIV240(ESC) | Part 1: BMS50+NIV240(ESC) | Part 1: BMS100+NIV240(ESC) | Part 1: BMS200+NIV240(ESC) | Part 1: BMS400+NIV240(ESC) | Part 2: Exp Cervical + (IDO 100) | Part 2: Exp Cervical + (IDO 200) | Part 2: Exp Pancreatic | Part 2: Exp DLBCL | Part 2: Exp SCCHN + (IDO 100) | Part 2: Exp SCCHN + (IDO 200) | Part 2: Exp Bladder + (IDO 100) | Part 2: Exp Bladder + (IDO 200) | Part 2: Exp ML I-O Naive | Part 2: Exp ML BRAF-MT | Part 2: Exp ML BRAF-MT- NIVO | Part 2: Exp ML Anti-PDL1 | Part 2: Exp ML Anti-PDL1+CTLA4 | Part 2: Exp NSCLC I-O Naive | Part 2: Exp NSCLC Anti-PDL1 | Part 2: Exp ASST | Part 2: Exp Renal | Part 3: Melanoma and NSCLC | Unplanned - BMS50 | Unplanned | QTc Substudy | Food Effect/ Relative BA (FE BA) Substudy | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 5 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 3 | 0 | 0 | 0 | 3 | 0 | 21 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 3 |
| Black or African American | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 4 | 2 | 3 | 0 | 1 | 0 | 0 | 2 | 1 | 19 |
| White | 5 | 10 | 10 | 11 | 6 | 15 | 16 | 21 | 32 | 15 | 14 | 14 | 16 | 70 | 7 | 6 | 28 | 16 | 64 | 33 | 29 | 39 | 36 | 1 | 1 | 15 | 13 | 543 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 7 | 2 | 0 | 7 | 0 | 11 | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 41 |
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Carcinoma, Non-Small-Cell Lung→
Bristol-Myers Squibb