Advanced Cancer, Melanoma, Non-Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen * During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type * Subjects must have measurable disease * Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening. * At least 4 weeks since any previous treatment for cancer * Must be able to swallow pills or capsules * Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
Exclusion criteria
* Active or chronic autoimmune diseases * Uncontrolled or significant cardiovascular disease * History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS) * Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma) * Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease * Active infection Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | From first dose to 100 days after last dose (up to 15 months) | Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation and deaths. |
| Number of Treated Participant With Laboratory Abnormalities - Thyroid | From first dose to 100 days after last dose (up to 15 months) | 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) |
| Number of Treated Participant With Laboratory Abnormalities - Liver | From first dose to 100 days after last dose (up to 15 months) | 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) |
| Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | 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. |
| Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | 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. |
| Median Duration of Response (DoR) - Parts 2 and 3 | 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) | 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. |
| Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | At 24 weeks after first dose | 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. |
| Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | At 1 year | 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. |
| Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | At 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | 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. |
| Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | 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. |
| Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | 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. |
| Cmax | At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks] | Cmax is defined as the maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205. |
| Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies | At 1 year | 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. |
| Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies | At 2 years | 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. |
| Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | From first dose to last dose (up to approximately 48 weeks) | 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. |
| Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies | At 24 weeks after first dose | 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. |
| Tmax | At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks] | Tmax is defined as the time of maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205. |
| AUC(TAU) | 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) | AUC(TAU) is defined as the area under the concentration-time curve in 1 dosing interval. Pharmacokinetic parameters measured here are for BMS-986205. |
| Ctrough | At cycles 0 [up to 2 weeks] and at cycles 3, 5, 7, 10, 11, 13, 15 [each cycle is up to 4 weeks] | Ctrough is defined as the trough observed plasma concentration at the end of the dosing interval. |
| CLT/F | At Cycle 0 Day 14 [cycle 0 = up to 2 weeks] | CLT/F is defined as the apparent total body clearance. Pharmacokinetic parameters measured here are for BMS-986205. |
| Accumulation Index (AI) - AUC(TAU) | 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) 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. |
| Accumulation Index (AI) - Cmax | At Cycle 0 Day 14 [cycle 0 = up to 2 weeks] | 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. |
| Change From Baseline in Serum Kynurenine | At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks] | 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 From Baseline in Serum Kynurenine | At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks] | 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. |
Countries
Australia, Canada, Finland, France, Germany, Italy, Norway, Poland, Spain, Sweden, United States
Participant flow
Pre-assignment details
Participants enrolled in the QTc Substudy and Food Effect/ Relative BA (FE BA) Substudy are separate participants from the Part 1 Dose Escalation phase.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: BMS25+NIV240(ESC) BMS-986205 25mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 7 |
| Part 1: BMS50+NIV240(ESC) BMS-986205 50mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 11 |
| Part 1: BMS100+NIV240(ESC) BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 12 |
| Part 1: BMS200+NIV240(ESC) BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 18 |
| Part 1: BMS400+NIV240(ESC) BMS-986205 400mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 7 |
| Part 2: Exp Cervical + (IDO 100) BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 18 |
| Part 2: Exp Cervical + (IDO 200) BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 17 |
| Part 2: Exp Pancreatic BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 22 |
| Part 2: Exp DLBCL BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 36 |
| Part 2: Exp SCCHN + (IDO 100) BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 15 |
| Part 2: Exp SCCHN + (IDO 200) BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 14 |
| Part 2: Exp Bladder + (IDO 100) BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 14 |
| Part 2: Exp Bladder + (IDO 200) BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks. | 16 |
| Part 2: Exp ML I-O Naive BMS-986205 100mg+ nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks. | 79 |
| Part 2: Exp ML BRAF-MT BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks. | 9 |
| Part 2: Exp ML BRAF-MT- NIVO Nivolumab 480mg administered as IV infusion once every 4 weeks. | 6 |
| Part 2: Exp ML Anti-PDL1 BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks. | 37 |
| Part 2: Exp ML Anti-PDL1+CTLA4 BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks. | 17 |
| Part 2: Exp NSCLC I-O Naive BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks. | 80 |
| Part 2: Exp NSCLC Anti-PDL1 BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks. | 41 |
| Part 2: Exp ASST BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks. | 32 |
| Part 2: Exp Renal BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks. | 42 |
| Part 3: Melanoma and NSCLC BMS-986205 + nivolumab + ipilimumab triple therapy. BMS-986205 administered orally in tablet or capsule formulation. Nivolumab and ipilimumab administered as IV infusion. | 41 |
| Unplanned - BMS50 BMS-986205 50mg administered orally in tablet or capsule formulation. | 1 |
| Unplanned Nivolumab 480mg administered as IV infusion. | 1 |
| QTc Substudy BMS-986205 + nivolumab combo therapy. BMS-986205 administered orally daily. Nivolumab administered as IV infusion. | 20 |
| Food Effect/ Relative BA (FE BA) Substudy BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion | 14 |
| Total | 627 |
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 | FG026 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Treatment Phase | 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 |
| Treatment Phase | 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 |
| Treatment Phase | 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 |
| Treatment Phase | 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 |
| Treatment Phase | 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 |
| Treatment Phase | 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 |
| Treatment Phase | 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 |
| Treatment Phase | 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 |
| Treatment Phase | 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 |
| Treatment Phase | 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 |
| Treatment Phase | 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 |
Baseline characteristics
| Characteristic | Part 2: Exp ML I-O Naive | 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 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized >= 18 to < 65 years | 41 Participants | 5 Participants | 8 Participants | 9 Participants | 13 Participants | 5 Participants | 16 Participants | 15 Participants | 13 Participants | 15 Participants | 9 Participants | 7 Participants | 6 Participants | 7 Participants | 6 Participants | 4 Participants | 20 Participants | 10 Participants | 52 Participants | 20 Participants | 19 Participants | 23 Participants | 26 Participants | 1 Participants | 0 Participants | 11 Participants | 10 Participants | 371 Participants |
| Age, Customized >= 65 to < 85 years | 37 Participants | 2 Participants | 3 Participants | 3 Participants | 5 Participants | 2 Participants | 2 Participants | 2 Participants | 9 Participants | 21 Participants | 6 Participants | 7 Participants | 8 Participants | 9 Participants | 3 Participants | 2 Participants | 16 Participants | 7 Participants | 28 Participants | 21 Participants | 13 Participants | 18 Participants | 15 Participants | 0 Participants | 1 Participants | 9 Participants | 4 Participants | 253 Participants |
| Age, Customized >= 85 years | 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 | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 4 Participants | 7 Participants | 7 Participants | 10 Participants | 4 Participants | 8 Participants | 8 Participants | 7 Participants | 4 Participants | 2 Participants | 8 Participants | 3 Participants | 6 Participants | 3 Participants | 5 Participants | 16 Participants | 5 Participants | 38 Participants | 15 Participants | 17 Participants | 21 Participants | 32 Participants | 0 Participants | 0 Participants | 15 Participants | 14 Participants | 302 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 34 Participants | 3 Participants | 3 Participants | 5 Participants | 8 Participants | 3 Participants | 9 Participants | 9 Participants | 12 Participants | 31 Participants | 13 Participants | 5 Participants | 9 Participants | 8 Participants | 6 Participants | 1 Participants | 21 Participants | 12 Participants | 42 Participants | 25 Participants | 15 Participants | 18 Participants | 8 Participants | 1 Participants | 1 Participants | 5 Participants | 0 Participants | 307 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 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 | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 1 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 | 1 Participants | 0 Participants | 4 Participants | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 19 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 | 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 | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 7 Participants | 0 Participants | 11 Participants | 5 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 41 Participants |
| Race (NIH/OMB) White | 70 Participants | 5 Participants | 10 Participants | 10 Participants | 11 Participants | 6 Participants | 15 Participants | 16 Participants | 21 Participants | 32 Participants | 15 Participants | 14 Participants | 14 Participants | 16 Participants | 7 Participants | 6 Participants | 28 Participants | 16 Participants | 64 Participants | 33 Participants | 29 Participants | 39 Participants | 36 Participants | 1 Participants | 1 Participants | 15 Participants | 13 Participants | 543 Participants |
| Sex: Female, Male Female | 26 Participants | 6 Participants | 6 Participants | 9 Participants | 10 Participants | 4 Participants | 18 Participants | 17 Participants | 7 Participants | 12 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 14 Participants | 6 Participants | 27 Participants | 17 Participants | 27 Participants | 8 Participants | 12 Participants | 0 Participants | 1 Participants | 16 Participants | 9 Participants | 267 Participants |
| Sex: Female, Male Male | 53 Participants | 1 Participants | 5 Participants | 3 Participants | 8 Participants | 3 Participants | 0 Participants | 0 Participants | 15 Participants | 24 Participants | 12 Participants | 12 Participants | 12 Participants | 13 Participants | 6 Participants | 4 Participants | 23 Participants | 11 Participants | 53 Participants | 24 Participants | 5 Participants | 34 Participants | 29 Participants | 1 Participants | 0 Participants | 4 Participants | 5 Participants | 360 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 | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 1 | 1 / 1 | 0 / 1 | 6 / 7 | 8 / 10 | 9 / 12 | 15 / 18 | 4 / 6 | 16 / 18 | 12 / 17 | 21 / 22 | 21 / 35 | 12 / 15 | 12 / 14 | 9 / 14 | 12 / 16 | 34 / 79 | 6 / 9 | 2 / 6 | 26 / 37 | 12 / 17 | 59 / 80 | 34 / 41 | 22 / 32 | 19 / 42 | 7 / 26 | 9 / 15 | 0 / 1 | 9 / 14 | 14 / 20 |
| other Total, other adverse events | 1 / 1 | 0 / 1 | 0 / 1 | 7 / 7 | 10 / 10 | 12 / 12 | 18 / 18 | 6 / 6 | 18 / 18 | 17 / 17 | 20 / 22 | 29 / 35 | 13 / 15 | 14 / 14 | 14 / 14 | 15 / 16 | 78 / 79 | 8 / 9 | 6 / 6 | 35 / 37 | 17 / 17 | 78 / 80 | 38 / 41 | 30 / 32 | 40 / 42 | 26 / 26 | 14 / 15 | 1 / 1 | 13 / 14 | 19 / 20 |
| serious Total, serious adverse events | 1 / 1 | 1 / 1 | 0 / 1 | 5 / 7 | 6 / 10 | 8 / 12 | 12 / 18 | 5 / 6 | 15 / 18 | 14 / 17 | 18 / 22 | 27 / 35 | 12 / 15 | 9 / 14 | 12 / 14 | 11 / 16 | 42 / 79 | 8 / 9 | 1 / 6 | 18 / 37 | 10 / 17 | 50 / 80 | 32 / 41 | 22 / 32 | 22 / 42 | 9 / 26 | 13 / 15 | 1 / 1 | 7 / 14 | 14 / 20 |
Outcome results
Primary
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)
Population: All treated participants in parts 2 and 3 who achieved a response (CR or PR)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: BMS400 (ESC) | Median Duration of Response (DoR) - Parts 2 and 3 | 134.14 Weeks |
| Unplanned - BMS50 | Median Duration of Response (DoR) - Parts 2 and 3 | NA Weeks |
| Part 1: BMS25+NIV240(ESC) | Median Duration of Response (DoR) - Parts 2 and 3 | 42.57 Weeks |
| Part 1: BMS50+NIV240(ESC) | Median Duration of Response (DoR) - Parts 2 and 3 | NA Weeks |
| Part 1: BMS100+NIV240(ESC) | Median Duration of Response (DoR) - Parts 2 and 3 | 76.14 Weeks |
| Part 1: BMS200+NIV240(ESC) | Median Duration of Response (DoR) - Parts 2 and 3 | NA Weeks |
| Part 1: BMS400+NIV240(ESC) | Median Duration of Response (DoR) - Parts 2 and 3 | NA Weeks |
| Part 2: Exp Cervical + (IDO 100) | Median Duration of Response (DoR) - Parts 2 and 3 | 144.14 Weeks |
| Part 2: Exp Cervical + (IDO 200) | Median Duration of Response (DoR) - Parts 2 and 3 | NA Weeks |
| Part 2: Exp Pancreatic | Median Duration of Response (DoR) - Parts 2 and 3 | NA Weeks |
| Part 2: Exp DLBCL | Median Duration of Response (DoR) - Parts 2 and 3 | NA Weeks |
| Part 2: Exp SCCHN + (IDO 100) | Median Duration of Response (DoR) - Parts 2 and 3 | 55.14 Weeks |
| Part 2: Exp SCCHN + (IDO 200) | Median Duration of Response (DoR) - Parts 2 and 3 | 51.79 Weeks |
| Part 2: Exp Bladder + (IDO 100) | Median Duration of Response (DoR) - Parts 2 and 3 | 32.14 Weeks |
| Part 2: Exp Bladder + (IDO 200) | Median Duration of Response (DoR) - Parts 2 and 3 | NA Weeks |
| Part 2: Exp ML I-O Naive | Median Duration of Response (DoR) - Parts 2 and 3 | 32.07 Weeks |
| Part 2: Exp ML BRAF-MT | Median Duration of Response (DoR) - Parts 2 and 3 | NA Weeks |
Primary
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)
Population: All treated participants in parts 2 and 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: BMS50 (ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 10 Participants |
| Part 1: BMS50 (ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 6 Participants |
| Part 1: BMS50 (ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 2 Participants |
| Part 1: BMS50 (ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 8 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 3 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 4 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 2 Participants |
| Unplanned - BMS50 | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 1 Participants |
| Unplanned - BMS50 | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 3 Participants |
| Unplanned - BMS50 | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 17 Participants |
| Unplanned - BMS50 | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 0 Participants |
| Unplanned - BMS50 | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 1 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 20 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 5 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 5 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 5 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 4 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 3 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 2 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 6 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 1 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 4 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 4 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 3 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 2 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 0 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 1 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 0 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 8 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 5 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 4 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 1 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 2 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 3 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 6 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 15 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 17 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 14 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 4 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 29 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 3 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 3 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 0 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 2 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 1 Participants |
| Part 2: Exp Pancreatic | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 1 Participants |
| Part 2: Exp Pancreatic | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 2 Participants |
| Part 2: Exp Pancreatic | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 2 Participants |
| Part 2: Exp Pancreatic | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 1 Participants |
| Part 2: Exp Pancreatic | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 0 Participants |
| Part 2: Exp DLBCL | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 11 Participants |
| Part 2: Exp DLBCL | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 0 Participants |
| Part 2: Exp DLBCL | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 1 Participants |
| Part 2: Exp DLBCL | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 23 Participants |
| Part 2: Exp DLBCL | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 2 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 0 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 3 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 2 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 9 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 3 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 28 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 12 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 10 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 2 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 28 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 4 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 2 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 14 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 21 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 0 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 0 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 15 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 4 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 3 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 10 Participants |
| Part 2: Exp ML I-O Naive | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 13 Participants |
| Part 2: Exp ML I-O Naive | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 0 Participants |
| Part 2: Exp ML I-O Naive | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 17 Participants |
| Part 2: Exp ML I-O Naive | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 4 Participants |
| Part 2: Exp ML I-O Naive | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 8 Participants |
| Part 2: Exp ML BRAF-MT | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Complete response (CR) | 5 Participants |
| Part 2: Exp ML BRAF-MT | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Progressive disease (PD) | 9 Participants |
| Part 2: Exp ML BRAF-MT | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Stable disease (SD) | 11 Participants |
| Part 2: Exp ML BRAF-MT | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Unable to determine (UTD) | 4 Participants |
| Part 2: Exp ML BRAF-MT | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | Partial response (PR) | 12 Participants |
Primary
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)
Population: All treated participants in parts 1, 2, and 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: BMS50 (ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 1 Participants |
| Part 1: BMS50 (ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 1 Participants |
| Part 1: BMS50 (ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 1 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 1 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 1 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 1 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 1 Participants |
| Unplanned - BMS50 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 0 Participants |
| Unplanned - BMS50 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 0 Participants |
| Unplanned - BMS50 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 0 Participants |
| Unplanned - BMS50 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 7 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 1 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 5 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 6 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 8 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 10 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 1 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 6 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 8 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 9 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 11 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 4 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 4 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 15 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 12 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 18 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 5 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 4 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 6 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 0 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 16 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 15 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 2 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 18 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 0 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 14 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 12 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 17 Participants |
| Part 2: Exp Pancreatic | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 21 Participants |
| Part 2: Exp Pancreatic | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 7 Participants |
| Part 2: Exp Pancreatic | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 18 Participants |
| Part 2: Exp Pancreatic | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 21 Participants |
| Part 2: Exp DLBCL | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 34 Participants |
| Part 2: Exp DLBCL | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 27 Participants |
| Part 2: Exp DLBCL | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 6 Participants |
| Part 2: Exp DLBCL | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 21 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 3 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 11 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 12 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 15 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 4 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 9 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 14 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 12 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 12 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 9 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 14 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 2 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 12 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 6 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 16 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 11 Participants |
| Part 2: Exp ML I-O Naive | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 79 Participants |
| Part 2: Exp ML I-O Naive | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 42 Participants |
| Part 2: Exp ML I-O Naive | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 16 Participants |
| Part 2: Exp ML I-O Naive | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 34 Participants |
| Part 2: Exp ML BRAF-MT | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 8 Participants |
| Part 2: Exp ML BRAF-MT | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 8 Participants |
| Part 2: Exp ML BRAF-MT | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 1 Participants |
| Part 2: Exp ML BRAF-MT | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 6 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 2 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 6 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 1 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 1 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 26 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 35 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 3 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 18 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 10 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 4 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 12 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 17 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 80 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 50 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 15 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 59 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 34 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 32 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 39 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 6 Participants |
| Part 2: Exp ASST | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 31 Participants |
| Part 2: Exp ASST | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 22 Participants |
| Part 2: Exp ASST | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 7 Participants |
| Part 2: Exp ASST | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 22 Participants |
| Part 2: Exp Renal | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 22 Participants |
| Part 2: Exp Renal | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 3 Participants |
| Part 2: Exp Renal | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 41 Participants |
| Part 2: Exp Renal | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 19 Participants |
| Part 3: Melanoma and NSCLC | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 16 Participants |
| Part 3: Melanoma and NSCLC | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 22 Participants |
| Part 3: Melanoma and NSCLC | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 1 Participants |
| Part 3: Melanoma and NSCLC | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 41 Participants |
| Unplanned | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | AEs Leading to Discontinuation | 0 Participants |
| Unplanned | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Adverse Events | 1 Participants |
| Unplanned | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Deaths | 0 Participants |
| Unplanned | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Serious Adverse Events | 1 Participants |
Primary
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)
Population: All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter in parts 1, 2, and 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 1 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 0 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 0 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 2 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 1 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 0 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 1 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 1 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 1 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 1 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 5 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 7 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 3 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 2 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 1 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 1 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 1 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 6 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 1 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 3 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 4 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 3 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 6 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 6 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 2 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 1 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 4 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 5 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 1 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 0 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 1 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 1 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 1 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 2 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 2 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 1 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 1 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 2 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 1 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 3 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 3 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 4 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 3 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 3 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 3 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 5 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 1 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 7 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 4 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 3 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 5 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 3 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 16 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 21 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 2 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 1 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 2 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 1 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 1 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 0 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 0 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 1 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 4 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 3 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 1 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 4 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 1 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 1 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 2 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 2 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 2 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 1 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 2 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 2 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 8 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 10 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 2 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 15 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 2 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 3 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 4 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 1 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 2 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 2 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 1 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 4 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 2 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 1 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 7 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 5 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 1 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 1 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 1 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 2 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 1 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 1 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 4 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 1 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 2 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 15 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 12 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 4 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Liver | Total Bilirubin > 2X ULN | 0 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 3X ULN | 1 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 5X ULN | 0 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 30 days | 0 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 20X ULN | 0 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Liver | Concurrent ALT or AST elevation > 3X ULN with total bilirubin > 2X ULN within 1 day | 0 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Liver | ALT or AST > 10X ULN | 0 Participants |
Primary
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)
Population: All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter in parts 1, 2, and 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 0 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 0 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 0 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 0 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 0 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 0 Participants |
| Unplanned - BMS50 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 1 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 1 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 1 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 1 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 2 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 1 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 1 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 1 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 3 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 2 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 0 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 2 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 1 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 2 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 2 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 1 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 1 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 1 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 2 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 0 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 1 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 3 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 1 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 1 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 1 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 1 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 2 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 4 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 7 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 5 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 2 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 1 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 2 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 7 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 1 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 2 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 1 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 1 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 1 Participants |
| Part 2: Exp Pancreatic | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 2 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 1 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 2 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 2 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 0 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 2 Participants |
| Part 2: Exp DLBCL | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 2 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 1 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 6 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 4 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 2 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 1 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 4 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 3 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 6 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 4 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 0 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 1 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 2 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 3 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 3 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 3 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 0 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 2 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 3 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 2 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 3 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 4 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 2 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 0 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 3 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 17 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 19 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 5 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 15 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 15 Participants |
| Part 2: Exp ML I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 17 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 0 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 2 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 1 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 1 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 1 Participants |
| Part 2: Exp ML BRAF-MT | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 2 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 1 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 1 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 1 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 0 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 0 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 1 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 1 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 3 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 1 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 5 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 3 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 3 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 1 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 5 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 4 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 1 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 1 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 4 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 7 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 5 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 16 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 19 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 13 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 25 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 1 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 1 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 4 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 3 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 4 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 0 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 8 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 7 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 9 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 7 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 8 Participants |
| Part 2: Exp ASST | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 3 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 7 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 9 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 10 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 17 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 4 Participants |
| Part 2: Exp Renal | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 9 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 8 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 15 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 4 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 10 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 4 Participants |
| Part 3: Melanoma and NSCLC | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 12 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with TSH ≤ ULN at baseline | 0 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with at least one FT3/FT4 test value > ULN | 1 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN with at least one FT3/FT4 test value < LLN | 0 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN | 1 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH > ULN | 0 Participants |
| Unplanned | Number of Treated Participant With Laboratory Abnormalities - Thyroid | TSH < LLN with TSH ≥ LLN at baseline | 1 Participants |
Primary
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)
Population: All treated participants in parts 2 and 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: BMS50 (ESC) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 0 Percentage of participants |
| Part 1: BMS400 (ESC) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 23.5 Percentage of participants |
| Unplanned - BMS50 | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 4.5 Percentage of participants |
| Part 1: BMS25+NIV240(ESC) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 14.3 Percentage of participants |
| Part 1: BMS50+NIV240(ESC) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 13.3 Percentage of participants |
| Part 1: BMS100+NIV240(ESC) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 28.6 Percentage of participants |
| Part 1: BMS200+NIV240(ESC) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 42.9 Percentage of participants |
| Part 1: BMS400+NIV240(ESC) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 31.3 Percentage of participants |
| Part 2: Exp Cervical + (IDO 100) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 40.5 Percentage of participants |
| Part 2: Exp Cervical + (IDO 200) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 44.4 Percentage of participants |
| Part 2: Exp Pancreatic | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 50.0 Percentage of participants |
| Part 2: Exp DLBCL | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 2.7 Percentage of participants |
| Part 2: Exp SCCHN + (IDO 100) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 11.8 Percentage of participants |
| Part 2: Exp SCCHN + (IDO 200) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 17.5 Percentage of participants |
| Part 2: Exp Bladder + (IDO 100) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 9.8 Percentage of participants |
| Part 2: Exp Bladder + (IDO 200) | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 9.4 Percentage of participants |
| Part 2: Exp ML I-O Naive | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 19 Percentage of participants |
| Part 2: Exp ML BRAF-MT | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | 41.5 Percentage of participants |
Primary
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
Population: All treated participants in parts 2 and 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: BMS50 (ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | NA Percentage of participants |
| Part 1: BMS400 (ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 19.0 Percentage of participants |
| Unplanned - BMS50 | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 4.5 Percentage of participants |
| Part 1: BMS25+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 8.1 Percentage of participants |
| Part 1: BMS50+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 13.3 Percentage of participants |
| Part 1: BMS100+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 34.3 Percentage of participants |
| Part 1: BMS200+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 28.6 Percentage of participants |
| Part 1: BMS400+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 31.3 Percentage of participants |
| Part 2: Exp Cervical + (IDO 100) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 39.8 Percentage of participants |
| Part 2: Exp Cervical + (IDO 200) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 26.7 Percentage of participants |
| Part 2: Exp Pancreatic | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 50 Percentage of participants |
| Part 2: Exp DLBCL | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 6 Percentage of participants |
| Part 2: Exp SCCHN + (IDO 100) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 11.8 Percentage of participants |
| Part 2: Exp SCCHN + (IDO 200) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 20.9 Percentage of participants |
| Part 2: Exp Bladder + (IDO 100) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 5.3 Percentage of participants |
| Part 2: Exp Bladder + (IDO 200) | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 20.2 Percentage of participants |
| Part 2: Exp ML I-O Naive | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 10.7 Percentage of participants |
| Part 2: Exp ML BRAF-MT | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | 47.3 Percentage of participants |
Primary
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
Population: All treated participants in parts 2 and 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: BMS50 (ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 6.6 Percentage of participants |
| Part 1: BMS400 (ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 38.0 Percentage of participants |
| Unplanned - BMS50 | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 4.5 Percentage of participants |
| Part 1: BMS25+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 24.2 Percentage of participants |
| Part 1: BMS50+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 20.0 Percentage of participants |
| Part 1: BMS100+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 42.9 Percentage of participants |
| Part 1: BMS200+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 42.9 Percentage of participants |
| Part 1: BMS400+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 37.5 Percentage of participants |
| Part 2: Exp Cervical + (IDO 100) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 48.2 Percentage of participants |
| Part 2: Exp Cervical + (IDO 200) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 53.3 Percentage of participants |
| Part 2: Exp Pancreatic | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 50 Percentage of participants |
| Part 2: Exp DLBCL | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 15.1 Percentage of participants |
| Part 2: Exp SCCHN + (IDO 100) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 17.6 Percentage of participants |
| Part 2: Exp SCCHN + (IDO 200) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 37.3 Percentage of participants |
| Part 2: Exp Bladder + (IDO 100) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 23.7 Percentage of participants |
| Part 2: Exp Bladder + (IDO 200) | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 36.4 Percentage of participants |
| Part 2: Exp ML I-O Naive | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 34.8 Percentage of participants |
| Part 2: Exp ML BRAF-MT | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | 56 Percentage of participants |
Primary
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
Population: All treated participants in parts 2 and 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: BMS50 (ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | NA Percentage of participants |
| Part 1: BMS400 (ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 12.7 Percentage of participants |
| Unplanned - BMS50 | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 4.5 Percentage of participants |
| Part 1: BMS25+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 4.0 Percentage of participants |
| Part 1: BMS50+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 6.7 Percentage of participants |
| Part 1: BMS100+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 8.6 Percentage of participants |
| Part 1: BMS200+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 21.4 Percentage of participants |
| Part 1: BMS400+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 25.0 Percentage of participants |
| Part 2: Exp Cervical + (IDO 100) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 34.0 Percentage of participants |
| Part 2: Exp Cervical + (IDO 200) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 26.7 Percentage of participants |
| Part 2: Exp Pancreatic | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 50 Percentage of participants |
| Part 2: Exp DLBCL | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 6 Percentage of participants |
| Part 2: Exp SCCHN + (IDO 100) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 11.8 Percentage of participants |
| Part 2: Exp SCCHN + (IDO 200) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 8.3 Percentage of participants |
| Part 2: Exp Bladder + (IDO 100) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 2.6 Percentage of participants |
| Part 2: Exp Bladder + (IDO 200) | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 12.1 Percentage of participants |
| Part 2: Exp ML I-O Naive | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 5.4 Percentage of participants |
| Part 2: Exp ML BRAF-MT | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | 31.8 Percentage of participants |
Secondary
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)
Population: All treated participants with evaluable pharmacokinetic measurements in Part 1
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: BMS50 (ESC) | Accumulation Index (AI) - AUC(TAU) | 2.966 Ratio | Geometric Coefficient of Variation 20 |
| Part 1: BMS400 (ESC) | Accumulation Index (AI) - AUC(TAU) | 2.380 Ratio | Geometric Coefficient of Variation 67 |
| Unplanned - BMS50 | Accumulation Index (AI) - AUC(TAU) | 2.290 Ratio | Geometric Coefficient of Variation 63 |
| Part 1: BMS25+NIV240(ESC) | Accumulation Index (AI) - AUC(TAU) | 2.360 Ratio | Geometric Coefficient of Variation 43 |
| Part 1: BMS50+NIV240(ESC) | Accumulation Index (AI) - AUC(TAU) | 1.9 Ratio | Geometric Coefficient of Variation 49 |
Secondary
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]
Population: All treated participants with evaluable pharmacokinetic measurements in Part 1
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: BMS50 (ESC) | Accumulation Index (AI) - Cmax | 1.603 Ratio | Geometric Coefficient of Variation 45 |
| Part 1: BMS400 (ESC) | Accumulation Index (AI) - Cmax | 1.523 Ratio | Geometric Coefficient of Variation 55 |
| Unplanned - BMS50 | Accumulation Index (AI) - Cmax | 1.360 Ratio | Geometric Coefficient of Variation 66 |
| Part 1: BMS25+NIV240(ESC) | Accumulation Index (AI) - Cmax | 1.646 Ratio | Geometric Coefficient of Variation 59 |
| Part 1: BMS50+NIV240(ESC) | Accumulation Index (AI) - Cmax | 1.505 Ratio | Geometric Coefficient of Variation 52 |
Secondary
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)
Population: All treated participants with evaluable pharmacokinetic measurements in Part 1
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BMS50 (ESC) | AUC(TAU) | Cycle 0, Day 14 | 2079.137 h*ng/mL | Geometric Coefficient of Variation 23 |
| Part 1: BMS50 (ESC) | AUC(TAU) | Cycle 0, Day 1 | 700.886 h*ng/mL | Geometric Coefficient of Variation 30 |
| Part 1: BMS400 (ESC) | AUC(TAU) | Cycle 0, Day 14 | 2531.139 h*ng/mL | Geometric Coefficient of Variation 65 |
| Part 1: BMS400 (ESC) | AUC(TAU) | Cycle 0, Day 1 | 1125.546 h*ng/mL | Geometric Coefficient of Variation 54 |
| Unplanned - BMS50 | AUC(TAU) | Cycle 0, Day 14 | 4949.909 h*ng/mL | Geometric Coefficient of Variation 54 |
| Unplanned - BMS50 | AUC(TAU) | Cycle 0, Day 1 | 2271.901 h*ng/mL | Geometric Coefficient of Variation 53 |
| Part 1: BMS25+NIV240(ESC) | AUC(TAU) | Cycle 0, Day 1 | 5091.460 h*ng/mL | Geometric Coefficient of Variation 53 |
| Part 1: BMS25+NIV240(ESC) | AUC(TAU) | Cycle 0, Day 14 | 13073.275 h*ng/mL | Geometric Coefficient of Variation 41 |
| Part 1: BMS50+NIV240(ESC) | AUC(TAU) | Cycle 0, Day 14 | 19473.051 h*ng/mL | Geometric Coefficient of Variation 46 |
| Part 1: BMS50+NIV240(ESC) | AUC(TAU) | Cycle 0, Day 1 | 10479.864 h*ng/mL | Geometric Coefficient of Variation 73 |
Secondary
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]
Population: All Treated Participants with evaluable serum kynurenine measurements in parts 1, 2, and 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: BMS25+NIV240(ESC) | Change From Baseline in Serum Kynurenine | -208.7 microMolars | Standard Deviation 112 |
| Part 1: BMS50+NIV240(ESC) | Change From Baseline in Serum Kynurenine | -262 microMolars | Standard Deviation 111.2 |
| Part 1: BMS100+NIV240(ESC) | Change From Baseline in Serum Kynurenine | -369.7 microMolars | Standard Deviation 200.8 |
| Part 1: BMS200+NIV240(ESC) | Change From Baseline in Serum Kynurenine | -314 microMolars | Standard Deviation 243.3 |
| Part 1: BMS400+NIV240(ESC) | Change From Baseline in Serum Kynurenine | -326.4 microMolars | Standard Deviation 193.8 |
| Part 2: Exp Cervical + (IDO 100) | Change From Baseline in Serum Kynurenine | -378.1 microMolars | Standard Deviation 241.1 |
| Part 2: Exp Cervical + (IDO 200) | Change From Baseline in Serum Kynurenine | -361.9 microMolars | Standard Deviation 153.3 |
| Part 2: Exp Pancreatic | Change From Baseline in Serum Kynurenine | -278.6 microMolars | Standard Deviation 214.4 |
| Part 2: Exp DLBCL | Change From Baseline in Serum Kynurenine | -391 microMolars | Standard Deviation 230.1 |
| Part 2: Exp SCCHN + (IDO 100) | Change From Baseline in Serum Kynurenine | -281.9 microMolars | Standard Deviation 144.1 |
| Part 2: Exp SCCHN + (IDO 200) | Change From Baseline in Serum Kynurenine | -495.1 microMolars | Standard Deviation 281.6 |
| Part 2: Exp Bladder + (IDO 100) | Change From Baseline in Serum Kynurenine | -331.5 microMolars | Standard Deviation 199.1 |
| Part 2: Exp Bladder + (IDO 200) | Change From Baseline in Serum Kynurenine | -398.9 microMolars | Standard Deviation 155.5 |
| Part 2: Exp ML I-O Naive | Change From Baseline in Serum Kynurenine | -371.8 microMolars | Standard Deviation 171.5 |
| Part 2: Exp ML BRAF-MT | Change From Baseline in Serum Kynurenine | -386.4 microMolars | Standard Deviation 109 |
| Part 2: Exp ML BRAF-MT- NIVO | Change From Baseline in Serum Kynurenine | 124.4 microMolars | Standard Deviation 141.3 |
| Part 2: Exp ML Anti-PDL1 | Change From Baseline in Serum Kynurenine | -399 microMolars | Standard Deviation 161 |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Change From Baseline in Serum Kynurenine | -325.4 microMolars | Standard Deviation 117.6 |
| Part 2: Exp NSCLC I-O Naive | Change From Baseline in Serum Kynurenine | -360.7 microMolars | Standard Deviation 162.3 |
| Part 2: Exp NSCLC Anti-PDL1 | Change From Baseline in Serum Kynurenine | -487.2 microMolars | Standard Deviation 193 |
| Part 2: Exp ASST | Change From Baseline in Serum Kynurenine | -317.8 microMolars | Standard Deviation 134.7 |
| Part 2: Exp Renal | Change From Baseline in Serum Kynurenine | -427.4 microMolars | Standard Deviation 156.4 |
Secondary
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]
Population: All treated participants with evaluable pharmacokinetic measurements in Part 1
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: BMS50 (ESC) | CLT/F | 12.024 L/h | Geometric Coefficient of Variation 23 |
| Part 1: BMS400 (ESC) | CLT/F | 19.754 L/h | Geometric Coefficient of Variation 65 |
| Unplanned - BMS50 | CLT/F | 20.202 L/h | Geometric Coefficient of Variation 54 |
| Part 1: BMS25+NIV240(ESC) | CLT/F | 15.298 L/h | Geometric Coefficient of Variation 41 |
| Part 1: BMS50+NIV240(ESC) | CLT/F | 20.541 L/h | Geometric Coefficient of Variation 46 |
Secondary
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]
Population: All treated participants with evaluable pharmacokinetic measurements in Part 1
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BMS50 (ESC) | Cmax | Cycle 0, Day 1 | 94.884 ng/mL | Geometric Coefficient of Variation 43 |
| Part 1: BMS50 (ESC) | Cmax | Cycle 0, Day 14 | 152.082 ng/mL | Geometric Coefficient of Variation 33 |
| Part 1: BMS400 (ESC) | Cmax | Cycle 0, Day 1 | 148.975 ng/mL | Geometric Coefficient of Variation 69 |
| Part 1: BMS400 (ESC) | Cmax | Cycle 0, Day 14 | 220.196 ng/mL | Geometric Coefficient of Variation 44 |
| Unplanned - BMS50 | Cmax | Cycle 0, Day 1 | 349.767 ng/mL | Geometric Coefficient of Variation 57 |
| Unplanned - BMS50 | Cmax | Cycle 0, Day 14 | 475.745 ng/mL | Geometric Coefficient of Variation 32 |
| Part 1: BMS25+NIV240(ESC) | Cmax | Cycle 0, Day 14 | 1091.549 ng/mL | Geometric Coefficient of Variation 50 |
| Part 1: BMS25+NIV240(ESC) | Cmax | Cycle 0, Day 1 | 613.202 ng/mL | Geometric Coefficient of Variation 60 |
| Part 1: BMS50+NIV240(ESC) | Cmax | Cycle 0, Day 1 | 1248.062 ng/mL | Geometric Coefficient of Variation 107 |
| Part 1: BMS50+NIV240(ESC) | Cmax | Cycle 0, Day 14 | 1912.682 ng/mL | Geometric Coefficient of Variation 61 |
Secondary
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]
Population: All treated participants with evaluable pharmacokinetic measurements
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BMS25+NIV240(ESC) | Ctrough | Cycle 0, Day 8 | 53.307 ng/mL | Geometric Coefficient of Variation 110 |
| Part 1: BMS25+NIV240(ESC) | Ctrough | Cycle 0, Day 2 | 12.020 ng/mL | Geometric Coefficient of Variation 37 |
| Part 1: BMS25+NIV240(ESC) | Ctrough | Cycle 0, Day 14 | 53.522 ng/mL | Geometric Coefficient of Variation 50 |
| Part 1: BMS25+NIV240(ESC) | Ctrough | Cycle 5, Day 1 | 52.371 ng/mL | Geometric Coefficient of Variation 19 |
| Part 1: BMS25+NIV240(ESC) | Ctrough | Cycle 3, Day 1 | 38.862 ng/mL | Geometric Coefficient of Variation 91 |
| Part 1: BMS50+NIV240(ESC) | Ctrough | Cycle 0, Day 14 | 65.590 ng/mL | Geometric Coefficient of Variation 100 |
| Part 1: BMS50+NIV240(ESC) | Ctrough | Cycle 0, Day 8 | 100.238 ng/mL | Geometric Coefficient of Variation 76 |
| Part 1: BMS50+NIV240(ESC) | Ctrough | Cycle 5, Day 1 | 23.974 ng/mL | Geometric Coefficient of Variation 305 |
| Part 1: BMS50+NIV240(ESC) | Ctrough | Cycle 0, Day 2 | 22.216 ng/mL | Geometric Coefficient of Variation 64 |
| Part 1: BMS50+NIV240(ESC) | Ctrough | Cycle 3, Day 1 | 76.193 ng/mL | Geometric Coefficient of Variation 1 |
| Part 1: BMS100+NIV240(ESC) | Ctrough | Cycle 0, Day 2 | 33.918 ng/mL | Geometric Coefficient of Variation 82 |
| Part 1: BMS100+NIV240(ESC) | Ctrough | Cycle 0, Day 14 | 112.154 ng/mL | Geometric Coefficient of Variation 84 |
| Part 1: BMS100+NIV240(ESC) | Ctrough | Cycle 5, Day 1 | 412.812 ng/mL | — |
| Part 1: BMS100+NIV240(ESC) | Ctrough | Cycle 3, Day 1 | 190.984 ng/mL | Geometric Coefficient of Variation 79 |
| Part 1: BMS100+NIV240(ESC) | Ctrough | Cycle 0, Day 8 | 86.651 ng/mL | Geometric Coefficient of Variation 155 |
| Part 1: BMS200+NIV240(ESC) | Ctrough | Cycle 5, Day 1 | 251.690 ng/mL | Geometric Coefficient of Variation 79 |
| Part 1: BMS200+NIV240(ESC) | Ctrough | Cycle 11, Day 1 | 427 ng/mL | — |
| Part 1: BMS200+NIV240(ESC) | Ctrough | Cycle 0, Day 8 | 322.492 ng/mL | Geometric Coefficient of Variation 38 |
| Part 1: BMS200+NIV240(ESC) | Ctrough | Cycle 7, Day 1 | 573.328 ng/mL | Geometric Coefficient of Variation 59 |
| Part 1: BMS200+NIV240(ESC) | Ctrough | Cycle 0, Day 14 | 332.165 ng/mL | Geometric Coefficient of Variation 66 |
| Part 1: BMS200+NIV240(ESC) | Ctrough | Cycle 0, Day 2 | 90.605 ng/mL | Geometric Coefficient of Variation 61 |
| Part 1: BMS200+NIV240(ESC) | Ctrough | Cycle 15, Day 1 | 1650 ng/mL | — |
| Part 1: BMS200+NIV240(ESC) | Ctrough | Cycle 10, Day 1 | 390 ng/mL | — |
| Part 1: BMS200+NIV240(ESC) | Ctrough | Cycle 3, Day 1 | 374.882 ng/mL | Geometric Coefficient of Variation 86 |
| Part 1: BMS400+NIV240(ESC) | Ctrough | Cycle 0, Day 14 | 373.479 ng/mL | Geometric Coefficient of Variation 213 |
| Part 1: BMS400+NIV240(ESC) | Ctrough | Cycle 3, Day 1 | 255.592 ng/mL | — |
| Part 1: BMS400+NIV240(ESC) | Ctrough | Cycle 0, Day 8 | 582.580 ng/mL | Geometric Coefficient of Variation 83 |
| Part 1: BMS400+NIV240(ESC) | Ctrough | Cycle 0, Day 2 | 225.065 ng/mL | Geometric Coefficient of Variation 60 |
| Part 2: Exp Cervical + (IDO 100) | Ctrough | Cycle 3, Day 1 | 281.639 ng/mL | Geometric Coefficient of Variation 83 |
| Part 2: Exp Cervical + (IDO 100) | Ctrough | Cycle 5, Day 1 | 147 ng/mL | — |
| Part 2: Exp Cervical + (IDO 200) | Ctrough | Cycle 10, Day 1 | 397.233 ng/mL | Geometric Coefficient of Variation 15 |
| Part 2: Exp Cervical + (IDO 200) | Ctrough | Cycle 11, Day 1 | 350 ng/mL | — |
| Part 2: Exp Cervical + (IDO 200) | Ctrough | Cycle 3, Day 1 | 394.303 ng/mL | Geometric Coefficient of Variation 42 |
| Part 2: Exp Cervical + (IDO 200) | Ctrough | Cycle 5, Day 1 | 375.415 ng/mL | Geometric Coefficient of Variation 47 |
| Part 2: Exp Pancreatic | Ctrough | Cycle 5, Day 1 | 39.556 ng/mL | Geometric Coefficient of Variation 37 |
| Part 2: Exp Pancreatic | Ctrough | Cycle 7, Day 1 | 41.3 ng/mL | — |
| Part 2: Exp Pancreatic | Ctrough | Cycle 10, Day 1 | 55.7 ng/mL | — |
| Part 2: Exp DLBCL | Ctrough | Cycle 7, Day 1 | 144.312 ng/mL | Geometric Coefficient of Variation 30 |
| Part 2: Exp DLBCL | Ctrough | Cycle 11, Day 1 | 95.121 ng/mL | Geometric Coefficient of Variation 65 |
| Part 2: Exp DLBCL | Ctrough | Cycle 15, Day 1 | 84.014 ng/mL | Geometric Coefficient of Variation 77 |
| Part 2: Exp DLBCL | Ctrough | Cycle 5, Day 1 | 183.272 ng/mL | Geometric Coefficient of Variation 69 |
| Part 2: Exp DLBCL | Ctrough | Cycle 3, Day 1 | 140.834 ng/mL | Geometric Coefficient of Variation 62 |
| Part 2: Exp SCCHN + (IDO 100) | Ctrough | Cycle 3, Day 1 | 139.560 ng/mL | Geometric Coefficient of Variation 79 |
| Part 2: Exp SCCHN + (IDO 100) | Ctrough | Cycle 13, Day 1 | 55 ng/mL | — |
| Part 2: Exp SCCHN + (IDO 100) | Ctrough | Cycle 5, Day 1 | 133.796 ng/mL | Geometric Coefficient of Variation 99 |
| Part 2: Exp SCCHN + (IDO 100) | Ctrough | Cycle 10, Day 1 | 65.1 ng/mL | — |
| Part 2: Exp SCCHN + (IDO 100) | Ctrough | Cycle 7, Day 1 | 246.552 ng/mL | Geometric Coefficient of Variation 45 |
| Part 2: Exp SCCHN + (IDO 200) | Ctrough | Cycle 5, Day 1 | 201.574 ng/mL | Geometric Coefficient of Variation 63 |
| Part 2: Exp SCCHN + (IDO 200) | Ctrough | Cycle 15, Day 1 | 287 ng/mL | — |
| Part 2: Exp SCCHN + (IDO 200) | Ctrough | Cycle 3, Day 1 | 240.978 ng/mL | Geometric Coefficient of Variation 87 |
| Part 2: Exp Bladder + (IDO 100) | Ctrough | Cycle 5, Day 1 | 169.231 ng/mL | Geometric Coefficient of Variation 114 |
| Part 2: Exp Bladder + (IDO 100) | Ctrough | Cycle 13, Day 1 | 53.072 ng/mL | Geometric Coefficient of Variation 29 |
| Part 2: Exp Bladder + (IDO 100) | Ctrough | Cycle 10, Day 1 | 305.405 ng/mL | Geometric Coefficient of Variation 22 |
| Part 2: Exp Bladder + (IDO 100) | Ctrough | Cycle 15, Day 1 | 104.517 ng/mL | Geometric Coefficient of Variation 318 |
| Part 2: Exp Bladder + (IDO 100) | Ctrough | Cycle 3, Day 1 | 121.641 ng/mL | Geometric Coefficient of Variation 52 |
| Part 2: Exp Bladder + (IDO 200) | Ctrough | Cycle 15, Day 1 | 171 ng/mL | — |
| Part 2: Exp Bladder + (IDO 200) | Ctrough | Cycle 3, Day 1 | 252.083 ng/mL | Geometric Coefficient of Variation 8 |
| Part 2: Exp Bladder + (IDO 200) | Ctrough | Cycle 5, Day 1 | 251.110 ng/mL | Geometric Coefficient of Variation 23 |
| Part 2: Exp ML I-O Naive | Ctrough | Cycle 5, Day 1 | 110.097 ng/mL | Geometric Coefficient of Variation 63 |
| Part 2: Exp ML I-O Naive | Ctrough | Cycle 3, Day 1 | 121.650 ng/mL | Geometric Coefficient of Variation 72 |
| Part 2: Exp ML I-O Naive | Ctrough | Cycle 13, Day 1 | 372 ng/mL | — |
| Part 2: Exp ML I-O Naive | Ctrough | Cycle 11, Day 1 | 150.150 ng/mL | Geometric Coefficient of Variation 80 |
| Part 2: Exp ML I-O Naive | Ctrough | Cycle 7, Day 1 | 120.596 ng/mL | Geometric Coefficient of Variation 79 |
| Part 2: Exp ML I-O Naive | Ctrough | Cycle 15, Day 1 | 109.168 ng/mL | Geometric Coefficient of Variation 63 |
| Part 2: Exp ML BRAF-MT | Ctrough | Cycle 5, Day 1 | 263.717 ng/mL | Geometric Coefficient of Variation 91 |
| Part 2: Exp ML BRAF-MT | Ctrough | Cycle 11, Day 1 | 237.382 ng/mL | Geometric Coefficient of Variation 45 |
| Part 2: Exp ML BRAF-MT | Ctrough | Cycle 3, Day 1 | 200.303 ng/mL | Geometric Coefficient of Variation 29 |
| Part 2: Exp ML BRAF-MT | Ctrough | Cycle 13, Day 1 | 336 ng/mL | — |
| Part 2: Exp ML Anti-PDL1 | Ctrough | Cycle 5, Day 1 | 96.255 ng/mL | Geometric Coefficient of Variation 162 |
| Part 2: Exp ML Anti-PDL1 | Ctrough | Cycle 7, Day 1 | 35.608 ng/mL | Geometric Coefficient of Variation 443 |
| Part 2: Exp ML Anti-PDL1 | Ctrough | Cycle 15, Day 1 | 11.2 ng/mL | — |
| Part 2: Exp ML Anti-PDL1 | Ctrough | Cycle 3, Day 1 | 127.464 ng/mL | Geometric Coefficient of Variation 144 |
| Part 2: Exp ML Anti-PDL1 | Ctrough | Cycle 11, Day 1 | 160.792 ng/mL | Geometric Coefficient of Variation 21 |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Ctrough | Cycle 5, Day 1 | 106.315 ng/mL | Geometric Coefficient of Variation 57 |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Ctrough | Cycle 3, Day 1 | 82.588 ng/mL | Geometric Coefficient of Variation 202 |
| Part 2: Exp NSCLC I-O Naive | Ctrough | Cycle 5, Day 1 | 149.506 ng/mL | Geometric Coefficient of Variation 55 |
| Part 2: Exp NSCLC I-O Naive | Ctrough | Cycle 3, Day 1 | 126.298 ng/mL | Geometric Coefficient of Variation 60 |
| Part 2: Exp NSCLC I-O Naive | Ctrough | Cycle 11, Day 1 | 137.222 ng/mL | Geometric Coefficient of Variation 76 |
| Part 2: Exp NSCLC I-O Naive | Ctrough | Cycle 7, Day 1 | 103.057 ng/mL | Geometric Coefficient of Variation 64 |
| Part 2: Exp NSCLC I-O Naive | Ctrough | Cycle 13, Day 1 | 129 ng/mL | — |
| Part 2: Exp NSCLC I-O Naive | Ctrough | Cycle 15, Day 1 | 104.957 ng/mL | Geometric Coefficient of Variation 38 |
| Part 2: Exp NSCLC Anti-PDL1 | Ctrough | Cycle 7, Day 1 | 149 ng/mL | — |
| Part 2: Exp NSCLC Anti-PDL1 | Ctrough | Cycle 5, Day 1 | 167.949 ng/mL | Geometric Coefficient of Variation 21 |
| Part 2: Exp NSCLC Anti-PDL1 | Ctrough | Cycle 3, Day 1 | 86.613 ng/mL | Geometric Coefficient of Variation 1021 |
| Part 2: Exp ASST | Ctrough | Cycle 13, Day 1 | 411 ng/mL | — |
| Part 2: Exp ASST | Ctrough | Cycle 3, Day 1 | 145.265 ng/mL | Geometric Coefficient of Variation 46 |
| Part 2: Exp ASST | Ctrough | Cycle 7, Day 1 | 84.598 ng/mL | Geometric Coefficient of Variation 168 |
| Part 2: Exp ASST | Ctrough | Cycle 5, Day 1 | 188.233 ng/mL | Geometric Coefficient of Variation 50 |
| Part 2: Exp Renal | Ctrough | Cycle 5, Day 1 | 105.164 ng/mL | Geometric Coefficient of Variation 107 |
| Part 2: Exp Renal | Ctrough | Cycle 7, Day 1 | 117.556 ng/mL | Geometric Coefficient of Variation 43 |
| Part 2: Exp Renal | Ctrough | Cycle 3, Day 1 | 114.018 ng/mL | Geometric Coefficient of Variation 72 |
| Food Effect/ Relative BA (FE BA) Substudy | Ctrough | Cycle 3, Day 1 | 137.123 ng/mL | Geometric Coefficient of Variation 71 |
| Food Effect/ Relative BA (FE BA) Substudy | Ctrough | Cycle 7, Day 1 | 161.750 ng/mL | Geometric Coefficient of Variation 95 |
| Food Effect/ Relative BA (FE BA) Substudy | Ctrough | Cycle 5, Day 1 | 78.595 ng/mL | Geometric Coefficient of Variation 101 |
| Food Effect/ Relative BA (FE BA) Substudy | Ctrough | Cycle 0, Day 8 | 10.021 ng/mL | Geometric Coefficient of Variation 106 |
Secondary
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)
Population: All treated participants in part 1 and clinical pharmacology substudies who achieved a response (CR or PR)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: BMS25+NIV240(ESC) | Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies | 52.14 Weeks |
| Part 1: BMS100+NIV240(ESC) | Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies | NA Weeks |
| Part 1: BMS400+NIV240(ESC) | Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies | NA Weeks |
| Part 2: Exp Cervical + (IDO 100) | Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies | NA Weeks |
Secondary
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)
Population: All treated participants in part 1 and clinical pharmacology substudies
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: BMS50 (ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Partial response (PR) | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Unable to determine (UTD) | 1 Participants |
| Part 1: BMS50 (ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Complete response (CR) | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Progressive disease (PD) | 0 Participants |
| Part 1: BMS50 (ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Stable disease (SD) | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Stable disease (SD) | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Complete response (CR) | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Unable to determine (UTD) | 1 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Partial response (PR) | 0 Participants |
| Part 1: BMS400 (ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Progressive disease (PD) | 0 Participants |
| Unplanned - BMS50 | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Progressive disease (PD) | 5 Participants |
| Unplanned - BMS50 | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Stable disease (SD) | 2 Participants |
| Unplanned - BMS50 | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Complete response (CR) | 0 Participants |
| Unplanned - BMS50 | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Unable to determine (UTD) | 0 Participants |
| Unplanned - BMS50 | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Partial response (PR) | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Unable to determine (UTD) | 1 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Partial response (PR) | 1 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Progressive disease (PD) | 5 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Complete response (CR) | 0 Participants |
| Part 1: BMS25+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Stable disease (SD) | 3 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Stable disease (SD) | 4 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Complete response (CR) | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Partial response (PR) | 0 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Progressive disease (PD) | 7 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Unable to determine (UTD) | 1 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Partial response (PR) | 1 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Stable disease (SD) | 4 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Progressive disease (PD) | 9 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Unable to determine (UTD) | 4 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Complete response (CR) | 0 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Stable disease (SD) | 2 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Partial response (PR) | 0 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Complete response (CR) | 0 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Progressive disease (PD) | 4 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Unable to determine (UTD) | 0 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Stable disease (SD) | 3 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Partial response (PR) | 1 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Unable to determine (UTD) | 2 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Progressive disease (PD) | 7 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Complete response (CR) | 1 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Unable to determine (UTD) | 3 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Complete response (CR) | 0 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Progressive disease (PD) | 14 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Partial response (PR) | 1 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | Stable disease (SD) | 2 Participants |
Secondary
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)
Population: All participants who received at least one dose of nivolumab or ipilimumab and have baseline and at least 1 post-treatment immunogenicity measurement in parts 1, 2, and 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: BMS25+NIV240(ESC) | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 1 Participants |
| Part 1: BMS50+NIV240(ESC) | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 0 Participants |
| Part 1: BMS100+NIV240(ESC) | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 0 Participants |
| Part 1: BMS200+NIV240(ESC) | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 0 Participants |
| Part 1: BMS400+NIV240(ESC) | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 0 Participants |
| Part 2: Exp Cervical + (IDO 100) | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 1 Participants |
| Part 2: Exp Cervical + (IDO 200) | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 2 Participants |
| Part 2: Exp Pancreatic | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 2 Participants |
| Part 2: Exp DLBCL | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 0 Participants |
| Part 2: Exp SCCHN + (IDO 100) | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 0 Participants |
| Part 2: Exp SCCHN + (IDO 200) | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 2 Participants |
| Part 2: Exp Bladder + (IDO 100) | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 1 Participants |
| Part 2: Exp Bladder + (IDO 200) | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 1 Participants |
| Part 2: Exp ML I-O Naive | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 1 Participants |
| Part 2: Exp ML BRAF-MT | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 0 Participants |
| Part 2: Exp ML BRAF-MT- NIVO | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 0 Participants |
| Part 2: Exp ML Anti-PDL1 | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 0 Participants |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 0 Participants |
| Part 2: Exp NSCLC I-O Naive | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 6 Participants |
| Part 2: Exp NSCLC Anti-PDL1 | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 0 Participants |
| Part 2: Exp ASST | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 1 Participants |
| Part 2: Exp Renal | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 3 Participants |
| Part 3: Melanoma and NSCLC | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Nivolumab ADA+ | 2 Participants |
| Part 3: Melanoma and NSCLC | Number of Participants With a Positive Anti-Drug Antibody (ADA) Test | Ipilimumab ADA+ | 1 Participants |
Secondary
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)
Population: All treated participants in part 1 and clinical pharmacology substudies
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: BMS50 (ESC) | Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies | 0 Percentage of participants |
| Part 1: BMS400 (ESC) | Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies | 0 Percentage of participants |
| Unplanned - BMS50 | Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies | 0 Percentage of participants |
| Part 1: BMS25+NIV240(ESC) | Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies | 10 Percentage of participants |
| Part 1: BMS50+NIV240(ESC) | Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies | 0 Percentage of participants |
| Part 1: BMS100+NIV240(ESC) | Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies | 5.6 Percentage of participants |
| Part 1: BMS200+NIV240(ESC) | Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies | 0 Percentage of participants |
| Part 1: BMS400+NIV240(ESC) | Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies | 14.3 Percentage of participants |
| Part 2: Exp Cervical + (IDO 100) | Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies | 5 Percentage of participants |
Secondary
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]
Population: All Treated Participants with evaluable serum kynurenine measurements in parts 1, 2, and 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: BMS25+NIV240(ESC) | Percent Change From Baseline in Serum Kynurenine | -37.7 Percent change | Standard Deviation 14.1 |
| Part 1: BMS50+NIV240(ESC) | Percent Change From Baseline in Serum Kynurenine | -46.6 Percent change | Standard Deviation 16.1 |
| Part 1: BMS100+NIV240(ESC) | Percent Change From Baseline in Serum Kynurenine | -56.4 Percent change | Standard Deviation 14.9 |
| Part 1: BMS200+NIV240(ESC) | Percent Change From Baseline in Serum Kynurenine | -44.7 Percent change | Standard Deviation 31.1 |
| Part 1: BMS400+NIV240(ESC) | Percent Change From Baseline in Serum Kynurenine | -44.1 Percent change | Standard Deviation 23.6 |
| Part 2: Exp Cervical + (IDO 100) | Percent Change From Baseline in Serum Kynurenine | -54 Percent change | Standard Deviation 22.1 |
| Part 2: Exp Cervical + (IDO 200) | Percent Change From Baseline in Serum Kynurenine | -61 Percent change | Standard Deviation 9.6 |
| Part 2: Exp Pancreatic | Percent Change From Baseline in Serum Kynurenine | -46.9 Percent change | Standard Deviation 15.8 |
| Part 2: Exp DLBCL | Percent Change From Baseline in Serum Kynurenine | -53.2 Percent change | Standard Deviation 20.4 |
| Part 2: Exp SCCHN + (IDO 100) | Percent Change From Baseline in Serum Kynurenine | -49.4 Percent change | Standard Deviation 24.8 |
| Part 2: Exp SCCHN + (IDO 200) | Percent Change From Baseline in Serum Kynurenine | -57 Percent change | Standard Deviation 22.3 |
| Part 2: Exp Bladder + (IDO 100) | Percent Change From Baseline in Serum Kynurenine | -49.3 Percent change | Standard Deviation 20.3 |
| Part 2: Exp Bladder + (IDO 200) | Percent Change From Baseline in Serum Kynurenine | -56.5 Percent change | Standard Deviation 15.2 |
| Part 2: Exp ML I-O Naive | Percent Change From Baseline in Serum Kynurenine | -57.8 Percent change | Standard Deviation 13.2 |
| Part 2: Exp ML BRAF-MT | Percent Change From Baseline in Serum Kynurenine | -57.9 Percent change | Standard Deviation 15.6 |
| Part 2: Exp ML BRAF-MT- NIVO | Percent Change From Baseline in Serum Kynurenine | 24.7 Percent change | Standard Deviation 23.8 |
| Part 2: Exp ML Anti-PDL1 | Percent Change From Baseline in Serum Kynurenine | -61.3 Percent change | Standard Deviation 12.8 |
| Part 2: Exp ML Anti-PDL1+CTLA4 | Percent Change From Baseline in Serum Kynurenine | -56.5 Percent change | Standard Deviation 11.9 |
| Part 2: Exp NSCLC I-O Naive | Percent Change From Baseline in Serum Kynurenine | -55.2 Percent change | Standard Deviation 14.2 |
| Part 2: Exp NSCLC Anti-PDL1 | Percent Change From Baseline in Serum Kynurenine | -61.5 Percent change | Standard Deviation 11.8 |
| Part 2: Exp ASST | Percent Change From Baseline in Serum Kynurenine | -50.8 Percent change | Standard Deviation 17.6 |
| Part 2: Exp Renal | Percent Change From Baseline in Serum Kynurenine | -55.3 Percent change | Standard Deviation 11.2 |
Secondary
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
Population: All treated participants in part 1 and clinical pharmacology substudies
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: BMS50 (ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Part 1: BMS400 (ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Unplanned - BMS50 | Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Part 1: BMS25+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies | 15 Percentage of participants |
| Part 1: BMS50+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Part 1: BMS100+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies | 21.2 Percentage of participants |
| Part 1: BMS200+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Part 1: BMS400+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies | 14.3 Percentage of participants |
| Part 2: Exp Cervical + (IDO 100) | Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies | 10.5 Percentage of participants |
Secondary
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
Population: All treated participants in part 1 and clinical pharmacology substudies
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: BMS50 (ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Part 1: BMS400 (ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Unplanned - BMS50 | Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies | 14.3 Percentage of participants |
| Part 1: BMS25+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies | 30.0 Percentage of participants |
| Part 1: BMS50+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies | 30.7 Percentage of participants |
| Part 1: BMS100+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies | 28.2 Percentage of participants |
| Part 1: BMS200+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Part 1: BMS400+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies | 35.7 Percentage of participants |
| Part 2: Exp Cervical + (IDO 100) | Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies | 10.5 Percentage of participants |
Secondary
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
Population: All treated participants in part 1 and clinical pharmacology substudies
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: BMS50 (ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Part 1: BMS400 (ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Unplanned - BMS50 | Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Part 1: BMS25+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Part 1: BMS50+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Part 1: BMS100+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies | 7.1 Percentage of participants |
| Part 1: BMS200+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies | NA Percentage of participants |
| Part 1: BMS400+NIV240(ESC) | Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies | 7.1 Percentage of participants |
| Part 2: Exp Cervical + (IDO 100) | Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies | 5.3 Percentage of participants |
Secondary
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]
Population: All treated participants with evaluable pharmacokinetic measurements in Part 1
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: BMS50 (ESC) | Tmax | Cycle 0, Day 14 | 3 hours |
| Part 1: BMS50 (ESC) | Tmax | Cycle 0, Day 1 | 3.050 hours |
| Part 1: BMS400 (ESC) | Tmax | Cycle 0, Day 1 | 3 hours |
| Part 1: BMS400 (ESC) | Tmax | Cycle 0, Day 14 | 4 hours |
| Unplanned - BMS50 | Tmax | Cycle 0, Day 1 | 4.025 hours |
| Unplanned - BMS50 | Tmax | Cycle 0, Day 14 | 3.025 hours |
| Part 1: BMS25+NIV240(ESC) | Tmax | Cycle 0, Day 14 | 3.017 hours |
| Part 1: BMS25+NIV240(ESC) | Tmax | Cycle 0, Day 1 | 4.009 hours |
| Part 1: BMS50+NIV240(ESC) | Tmax | Cycle 0, Day 14 | 3 hours |
| Part 1: BMS50+NIV240(ESC) | Tmax | Cycle 0, Day 1 | 4.300 hours |