Solid Tumors
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.
Interventions
DRUGBMS-986156
DRUGNivolumab
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * For Dose Escalation: * Subjects with any previously treated advanced (metastatic or refractory) solid tumor * For Cohort Expansion: * Subjects must have a previously treated advanced solid tumor to be eligible * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy * Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
Exclusion criteria
* Known central nervous system metastases or central nervous system as the only source of disease * Other concomitant malignancies (with some exceptions per protocol) * Active, known or suspected autoimmune disease * Uncontrolled or significant cardiovascular disease * History of active or chronic hepatitis (e.g. Hep B or C) * Impaired liver or bone marrow function * Major surgery less than 1 month before start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | From first treatment to 100 days post last dose. Approximately 29 months | Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths. AEs and laboratory values will be graded according to the NCI CTCAE version 4.03. |
| Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | From first treatment to 100 days post last dose. Approximately 29 months | Number of Participants with laboratory abnormalities in specific thyroid tests. TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number |
| Number of Participants With Laboratory Abnormalities in Specific Liver Tests | From first treatment to 100 days post last dose. Approximately 29 months | Number of Participants with laboratory abnormalities in specific liver tests. ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response | From first dose to disease progression after a response (Approximately 50 Months) | All treated participants with a BOR of CR or PR, 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. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Best Overall Response | From first dose to a response or progressive disease (Approximately 50 Months) | BOR will be defined by CR, PR, PD and SD Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one 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, taking as reference the smallest sum diameters while on study. |
| Number of Participants With Anti-Drug Antibody Response | At Cycle 3 Day 1; where each treatment cycle was 8 weeks | Number of participants with a positive Anti-Drug Antibody to BMS-986156 or nivolumab |
| Overall Response Rate | From first dose to CR and PR (Approximately 50 Months) | 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. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Progression Free Survival (PFS) | From first dose to disease progression (Approximately 50 Months) | The time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
Countries
Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Switzerland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A: BMS-986156 10mg BMS-986156 10mg Q2W | 4 |
| Part A: BMS-986156 30mg BMS-986156 30mg Q2W | 6 |
| Part A: BMS-986156 100mg BMS-986156 100mg Q2W | 4 |
| Part A: BMS-986156 240mg BMS-986156 240mg Q2W | 6 |
| Part A: BMS-986156 800mg BMS-986156 800mg Q2W | 9 |
| Part C: BMS-986156 240mg BMS-986156 240mg Q2W | 3 |
| Part C: BMS-986156 800mg BMS-986156 800mg Q2W | 2 |
| Part B: BMS-986156 30mg + Nivo 240mg BMS986156 30mg Q2W + Nivo 240mg Q2W | 3 |
| Part B: BMS-986156 100mg + Nivo 240mg BMS986156 100mg Q2W + Nivo 240mg Q2W | 9 |
| Part B: BMS-986156 240mg + Nivo 240mg BMS986156 240mg Q2W + Nivo 240mg Q2W | 14 |
| Part B: BMS-986156 800mg + Nivo 240mg BMS986156 800mg Q2W + Nivo 240mg Q2W | 11 |
| Part D: BMS-986156 240mg + Nivo 240mg BMS986156 240mg Q2W + Nivo 240mg Q2W | 188 |
| Part E: BMS-986156 480mg + Nivo 480mg BMS986156 480mg Q4W + Nivo 480mg Q4W | 33 |
| Total | 292 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Participants Entering Follow Up Period | Death | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 11 | 2 |
| Participants Entering Follow Up Period | follow up no longer required per protocol | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Participants Entering Follow Up Period | lost to follow up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
| Participants Entering Follow Up Period | Other Reasons | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 6 | 3 |
| Participants Entering Follow Up Period | participant withdrew consent | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 0 |
| Treatment Period | Adverse Event unrelated to study drug | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 11 | 2 |
| Treatment Period | Disease Progression | 4 | 4 | 4 | 6 | 8 | 2 | 2 | 3 | 7 | 9 | 7 | 143 | 23 |
| Treatment Period | No longer meets study criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Treatment Period | Other Reasons | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Treatment Period | participant request to discontinue | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 0 |
| Treatment Period | participant withdrew consent | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
| Treatment Period | Study drug toxicity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | Part A: BMS-986156 10mg | Part A: BMS-986156 30mg | Part A: BMS-986156 100mg | Part A: BMS-986156 240mg | Part A: BMS-986156 800mg | Part C: BMS-986156 240mg | Part C: BMS-986156 800mg | Part B: BMS-986156 30mg + Nivo 240mg | Part B: BMS-986156 100mg + Nivo 240mg | Part B: BMS-986156 240mg + Nivo 240mg | Part B: BMS-986156 800mg + Nivo 240mg | Part D: BMS-986156 240mg + Nivo 240mg | Part E: BMS-986156 480mg + Nivo 480mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 55.3 Years STANDARD_DEVIATION 18.57 | 59.7 Years STANDARD_DEVIATION 5.82 | 57.5 Years STANDARD_DEVIATION 10.08 | 49.5 Years STANDARD_DEVIATION 13.28 | 51.0 Years STANDARD_DEVIATION 13.82 | 58.3 Years STANDARD_DEVIATION 19.43 | 56.5 Years STANDARD_DEVIATION 9.19 | 50.7 Years STANDARD_DEVIATION 20.5 | 57.2 Years STANDARD_DEVIATION 12.09 | 55.6 Years STANDARD_DEVIATION 18.67 | 57.0 Years STANDARD_DEVIATION 9.3 | 59.0 Years STANDARD_DEVIATION 11.58 | 57.2 Years STANDARD_DEVIATION 13.05 | 57.9 Years STANDARD_DEVIATION 12.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 6 Participants | 1 Participants | 3 Participants | 5 Participants | 1 Participants | 0 Participants | 2 Participants | 6 Participants | 7 Participants | 4 Participants | 51 Participants | 11 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 4 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 7 Participants | 7 Participants | 136 Participants | 21 Participants | 187 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 |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 13 Participants | 5 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 3 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 |
| 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 3 Participants | 5 Participants | 8 Participants | 3 Participants | 2 Participants | 3 Participants | 8 Participants | 12 Participants | 11 Participants | 171 Participants | 27 Participants | 262 Participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 1 Participants | 3 Participants | 5 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants | 5 Participants | 7 Participants | 100 Participants | 22 Participants | 156 Participants |
| Sex: Female, Male Male | 0 Participants | 5 Participants | 3 Participants | 3 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 5 Participants | 9 Participants | 4 Participants | 88 Participants | 11 Participants | 136 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 4 | 5 / 6 | 3 / 4 | 5 / 6 | 6 / 9 | 2 / 3 | 2 / 2 | 3 / 3 | 6 / 9 | 11 / 14 | 8 / 11 | 141 / 188 | 27 / 33 |
| other Total, other adverse events | 4 / 4 | 5 / 6 | 4 / 4 | 6 / 6 | 9 / 9 | 3 / 3 | 1 / 2 | 2 / 3 | 8 / 9 | 14 / 14 | 11 / 11 | 185 / 188 | 31 / 33 |
| serious Total, serious adverse events | 3 / 4 | 3 / 6 | 1 / 4 | 5 / 6 | 4 / 9 | 2 / 3 | 2 / 2 | 2 / 3 | 5 / 9 | 10 / 14 | 6 / 11 | 121 / 188 | 22 / 33 |
Outcome results
Primary
Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths
Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths. AEs and laboratory values will be graded according to the NCI CTCAE version 4.03.
Time frame: From first treatment to 100 days post last dose. Approximately 29 months
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: BMS-986156 10mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 1 Participants |
| Part A: BMS-986156 10mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 3 Participants |
| Part A: BMS-986156 10mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 4 Participants |
| Part A: BMS-986156 10mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 4 Participants |
| Part A: BMS-986156 30mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 3 Participants |
| Part A: BMS-986156 30mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 2 Participants |
| Part A: BMS-986156 30mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 5 Participants |
| Part A: BMS-986156 30mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 6 Participants |
| Part A: BMS-986156 100mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 0 Participants |
| Part A: BMS-986156 100mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 3 Participants |
| Part A: BMS-986156 100mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 1 Participants |
| Part A: BMS-986156 100mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 4 Participants |
| Part A: BMS-986156 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 2 Participants |
| Part A: BMS-986156 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 5 Participants |
| Part A: BMS-986156 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 5 Participants |
| Part A: BMS-986156 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 6 Participants |
| Part A: BMS-986156 800mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 9 Participants |
| Part A: BMS-986156 800mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 6 Participants |
| Part A: BMS-986156 800mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 4 Participants |
| Part A: BMS-986156 800mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 1 Participants |
| Part C: BMS-986156 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 3 Participants |
| Part C: BMS-986156 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 2 Participants |
| Part C: BMS-986156 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 2 Participants |
| Part C: BMS-986156 800mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 2 Participants |
| Part C: BMS-986156 800mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 2 Participants |
| Part C: BMS-986156 800mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 2 Participants |
| Part C: BMS-986156 800mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 2 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 3 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 3 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 6 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 9 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 1 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 5 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 10 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 2 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 11 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 14 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 1 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 11 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 8 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 6 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 32 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 188 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 121 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 141 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Serious Adverse Events (SAEs) | 22 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Deaths | 27 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | AEs leading to Discontinuation | 5 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths | Adverse Events (AEs) | 33 Participants |
Primary
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Number of Participants with laboratory abnormalities in specific liver tests. ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase
Time frame: From first treatment to 100 days post last dose. Approximately 29 months
Population: All treated participants with at least one on - treatment liver test measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 0 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 0 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 0 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 0 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 0 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 1 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 0 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 0 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 2 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 0 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 1 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 1 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 1 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 0 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 0 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 1 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 1 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 0 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 1 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 0 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 1 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 0 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 1 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 0 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 0 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 0 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 2 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 0 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 0 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 0 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 0 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 0 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 0 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 1 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 0 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 2 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 0 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 0 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 0 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 1 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 1 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 1 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 1 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 1 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 2 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 0 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 2 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 0 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 0 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 0 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 1 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 1 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 0 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 1 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 1 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 2 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 7 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 2 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 0 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 3 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 0 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 1 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 1 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 2 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 2 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 0 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 3 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 0 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 0 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 5 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 25 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 14 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 6 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 1 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 7 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 70 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 6 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 1 DAY | 1 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALP > 1.5*ULN | 11 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2*ULN | 1 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 20*ULN | 0 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10*ULN | 0 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5*ULN | 1 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT OR AST > 3*ULN | 3 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Liver Tests | ALT/AST ELEV>3*ULN;TOTAL BILIRUBIN>2*ULN IN 30 DAYS | 1 Participants |
Primary
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Number of Participants with laboratory abnormalities in specific thyroid tests. TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number
Time frame: From first treatment to 100 days post last dose. Approximately 29 months
Population: All treated participants with at least one on - treatment TSH measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 0 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 0 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 0 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 1 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 0 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 0 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 2 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 0 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 0 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 1 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 0 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 0 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 2 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 0 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 0 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 0 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 0 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 0 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 0 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 2 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 1 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 1 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 0 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 1 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 1 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 0 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 4 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 4 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 4 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 3 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 2 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 2 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 2 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 0 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 5 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 72 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 38 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 42 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 26 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 24 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 37 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH < LLN | 10 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN | 5 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN | 19 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 8 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 11 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests | TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN | 9 Participants |
Secondary
Best Overall Response
BOR will be defined by CR, PR, PD and SD Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one 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, taking as reference the smallest sum diameters while on study.
Time frame: From first dose to a response or progressive disease (Approximately 50 Months)
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: BMS-986156 10mg | Best Overall Response | Stable Disease | 2 Participants |
| Part A: BMS-986156 10mg | Best Overall Response | Not Available | 0 Participants |
| Part A: BMS-986156 10mg | Best Overall Response | Progressive Disease | 1 Participants |
| Part A: BMS-986156 10mg | Best Overall Response | Complete Response | 0 Participants |
| Part A: BMS-986156 10mg | Best Overall Response | Partial Response | 0 Participants |
| Part A: BMS-986156 10mg | Best Overall Response | Not Evaluable | 1 Participants |
| Part A: BMS-986156 30mg | Best Overall Response | Not Evaluable | 2 Participants |
| Part A: BMS-986156 30mg | Best Overall Response | Not Available | 0 Participants |
| Part A: BMS-986156 30mg | Best Overall Response | Complete Response | 0 Participants |
| Part A: BMS-986156 30mg | Best Overall Response | Stable Disease | 1 Participants |
| Part A: BMS-986156 30mg | Best Overall Response | Progressive Disease | 3 Participants |
| Part A: BMS-986156 30mg | Best Overall Response | Partial Response | 0 Participants |
| Part A: BMS-986156 100mg | Best Overall Response | Partial Response | 0 Participants |
| Part A: BMS-986156 100mg | Best Overall Response | Progressive Disease | 2 Participants |
| Part A: BMS-986156 100mg | Best Overall Response | Not Available | 0 Participants |
| Part A: BMS-986156 100mg | Best Overall Response | Stable Disease | 2 Participants |
| Part A: BMS-986156 100mg | Best Overall Response | Complete Response | 0 Participants |
| Part A: BMS-986156 100mg | Best Overall Response | Not Evaluable | 0 Participants |
| Part A: BMS-986156 240mg | Best Overall Response | Progressive Disease | 4 Participants |
| Part A: BMS-986156 240mg | Best Overall Response | Complete Response | 0 Participants |
| Part A: BMS-986156 240mg | Best Overall Response | Not Available | 0 Participants |
| Part A: BMS-986156 240mg | Best Overall Response | Partial Response | 0 Participants |
| Part A: BMS-986156 240mg | Best Overall Response | Stable Disease | 1 Participants |
| Part A: BMS-986156 240mg | Best Overall Response | Not Evaluable | 1 Participants |
| Part A: BMS-986156 800mg | Best Overall Response | Progressive Disease | 4 Participants |
| Part A: BMS-986156 800mg | Best Overall Response | Not Available | 0 Participants |
| Part A: BMS-986156 800mg | Best Overall Response | Stable Disease | 4 Participants |
| Part A: BMS-986156 800mg | Best Overall Response | Partial Response | 0 Participants |
| Part A: BMS-986156 800mg | Best Overall Response | Not Evaluable | 1 Participants |
| Part A: BMS-986156 800mg | Best Overall Response | Complete Response | 0 Participants |
| Part C: BMS-986156 240mg | Best Overall Response | Partial Response | 0 Participants |
| Part C: BMS-986156 240mg | Best Overall Response | Not Evaluable | 0 Participants |
| Part C: BMS-986156 240mg | Best Overall Response | Not Available | 0 Participants |
| Part C: BMS-986156 240mg | Best Overall Response | Progressive Disease | 2 Participants |
| Part C: BMS-986156 240mg | Best Overall Response | Stable Disease | 1 Participants |
| Part C: BMS-986156 240mg | Best Overall Response | Complete Response | 0 Participants |
| Part C: BMS-986156 800mg | Best Overall Response | Stable Disease | 0 Participants |
| Part C: BMS-986156 800mg | Best Overall Response | Complete Response | 0 Participants |
| Part C: BMS-986156 800mg | Best Overall Response | Not Available | 0 Participants |
| Part C: BMS-986156 800mg | Best Overall Response | Progressive Disease | 2 Participants |
| Part C: BMS-986156 800mg | Best Overall Response | Partial Response | 0 Participants |
| Part C: BMS-986156 800mg | Best Overall Response | Not Evaluable | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Best Overall Response | Not Evaluable | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Best Overall Response | Complete Response | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Best Overall Response | Partial Response | 1 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Best Overall Response | Stable Disease | 2 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Best Overall Response | Progressive Disease | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Best Overall Response | Not Available | 0 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Best Overall Response | Stable Disease | 2 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Best Overall Response | Progressive Disease | 4 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Best Overall Response | Not Available | 0 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Best Overall Response | Complete Response | 0 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Best Overall Response | Partial Response | 1 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Best Overall Response | Not Evaluable | 2 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Best Overall Response | Progressive Disease | 4 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Best Overall Response | Stable Disease | 6 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Best Overall Response | Not Evaluable | 1 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Best Overall Response | Partial Response | 3 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Best Overall Response | Complete Response | 0 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Best Overall Response | Not Available | 0 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Best Overall Response | Partial Response | 1 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Best Overall Response | Progressive Disease | 4 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Best Overall Response | Not Evaluable | 0 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Best Overall Response | Not Available | 0 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Best Overall Response | Complete Response | 0 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Best Overall Response | Stable Disease | 6 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Best Overall Response | Partial Response | 17 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Best Overall Response | Progressive Disease | 91 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Best Overall Response | Stable Disease | 59 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Best Overall Response | Not Evaluable | 16 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Best Overall Response | Not Available | 1 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Best Overall Response | Complete Response | 4 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Best Overall Response | Partial Response | 1 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Best Overall Response | Complete Response | 2 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Best Overall Response | Progressive Disease | 15 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Best Overall Response | Not Available | 0 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Best Overall Response | Not Evaluable | 3 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Best Overall Response | Stable Disease | 12 Participants |
Secondary
Duration of Response
All treated participants with a BOR of CR or PR, 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. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From first dose to disease progression after a response (Approximately 50 Months)
Population: All treated participants with a CR or PR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part B: BMS-986156 100mg + Nivo 240mg | Duration of Response | 20.70 Months |
| Part B: BMS-986156 240mg + Nivo 240mg | Duration of Response | 30.10 Months |
| Part B: BMS-986156 800mg + Nivo 240mg | Duration of Response | NA Months |
| Part D: BMS-986156 240mg + Nivo 240mg | Duration of Response | NA Months |
| Part E: BMS-986156 480mg + Nivo 480mg | Duration of Response | NA Months |
Secondary
Number of Participants With Anti-Drug Antibody Response
Number of participants with a positive Anti-Drug Antibody to BMS-986156 or nivolumab
Time frame: At Cycle 3 Day 1; where each treatment cycle was 8 weeks
Population: All BMS-986156 or Nivolumab Treated participants with Baseline and at Least One Post-baseline Assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: BMS-986156 10mg | Number of Participants With Anti-Drug Antibody Response | Nivolumab | 0 Participants |
| Part A: BMS-986156 10mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 1 Participants |
| Part A: BMS-986156 30mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 0 Participants |
| Part A: BMS-986156 100mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 0 Participants |
| Part A: BMS-986156 240mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 0 Participants |
| Part A: BMS-986156 800mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 0 Participants |
| Part C: BMS-986156 240mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 0 Participants |
| Part C: BMS-986156 800mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 0 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 1 Participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Number of Participants With Anti-Drug Antibody Response | Nivolumab | 0 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Anti-Drug Antibody Response | Nivolumab | 0 Participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 0 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 0 Participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Number of Participants With Anti-Drug Antibody Response | Nivolumab | 4 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 0 Participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Number of Participants With Anti-Drug Antibody Response | Nivolumab | 1 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 5 Participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Number of Participants With Anti-Drug Antibody Response | Nivolumab | 32 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Anti-Drug Antibody Response | Nivolumab | 2 Participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Number of Participants With Anti-Drug Antibody Response | BMS-986156 | 0 Participants |
Secondary
Overall Response Rate
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. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From first dose to CR and PR (Approximately 50 Months)
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: BMS-986156 10mg | Overall Response Rate | 0 Percentage of participants |
| Part A: BMS-986156 30mg | Overall Response Rate | 0 Percentage of participants |
| Part A: BMS-986156 100mg | Overall Response Rate | 0 Percentage of participants |
| Part A: BMS-986156 240mg | Overall Response Rate | 0 Percentage of participants |
| Part A: BMS-986156 800mg | Overall Response Rate | 0 Percentage of participants |
| Part C: BMS-986156 240mg | Overall Response Rate | 0 Percentage of participants |
| Part C: BMS-986156 800mg | Overall Response Rate | 0 Percentage of participants |
| Part B: BMS-986156 30mg + Nivo 240mg | Overall Response Rate | 0 Percentage of participants |
| Part B: BMS-986156 100mg + Nivo 240mg | Overall Response Rate | 11.1 Percentage of participants |
| Part B: BMS-986156 240mg + Nivo 240mg | Overall Response Rate | 21.4 Percentage of participants |
| Part B: BMS-986156 800mg + Nivo 240mg | Overall Response Rate | 9.1 Percentage of participants |
| Part D: BMS-986156 240mg + Nivo 240mg | Overall Response Rate | 11.2 Percentage of participants |
| Part E: BMS-986156 480mg + Nivo 480mg | Overall Response Rate | 9.1 Percentage of participants |
Secondary
Progression Free Survival (PFS)
The time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: From first dose to disease progression (Approximately 50 Months)
Population: All treated participants with evaluable PFS measures
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: BMS-986156 10mg | Progression Free Survival (PFS) | 3.48 Months |
| Part A: BMS-986156 30mg | Progression Free Survival (PFS) | 1.74 Months |
| Part A: BMS-986156 100mg | Progression Free Survival (PFS) | 2.66 Months |
| Part A: BMS-986156 240mg | Progression Free Survival (PFS) | 1.64 Months |
| Part A: BMS-986156 800mg | Progression Free Survival (PFS) | 1.84 Months |
| Part C: BMS-986156 240mg | Progression Free Survival (PFS) | 1.64 Months |
| Part C: BMS-986156 800mg | Progression Free Survival (PFS) | 1.71 Months |
| Part B: BMS-986156 30mg + Nivo 240mg | Progression Free Survival (PFS) | 1.81 Months |
| Part B: BMS-986156 100mg + Nivo 240mg | Progression Free Survival (PFS) | 1.64 Months |
| Part B: BMS-986156 240mg + Nivo 240mg | Progression Free Survival (PFS) | 3.71 Months |
| Part B: BMS-986156 800mg + Nivo 240mg | Progression Free Survival (PFS) | 3.52 Months |
| Part D: BMS-986156 240mg + Nivo 240mg | Progression Free Survival (PFS) | 1.91 Months |
| Part E: BMS-986156 480mg + Nivo 480mg | Progression Free Survival (PFS) | 2.92 Months |