An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: BMS-986156
* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986156: Dose Escalation<br> | Drug: BMS-986156<br> <br> |
| Experimental: BMS-986156 + nivolumab (nivo): Dose Escalation<br> | Drug: BMS-986156<br> <br> Drug: Nivolumab<br> <br> |
| Experimental: BMS-986156: Dose Expansion<br> | Drug: BMS-986156<br> <br> |
| Experimental: BMS-986156 + nivolumab (nivo): Dose Expansion<br> | Drug: BMS-986156<br> <br> Drug: Nivolumab<br> <br> |
| Experimental: BMS986156 + Nivo: Cohort Expansion<br> | Drug: BMS-986156<br> <br> Drug: Nivolumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From first treatment to 100 days post last dose. Approximately 29 months | 
| 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 | From first treatment to 100 days post last dose. Approximately 29 months | 
| 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 | From first treatment to 100 days post last dose. Approximately 29 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From first dose to a response or progressive disease (Approximately 50 Months) | 
| 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. | From first dose to CR and PR (Approximately 50 Months) | 
| 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). | From first dose to disease progression (Approximately 50 Months) | 
| 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. | From first dose to disease progression after a response (Approximately 50 Months) | 
| Number of Participants With Anti-Drug Antibody Response | Number of participants with a positive Anti-Drug Antibody to BMS-986156 or nivolumab | At Cycle 3 Day 1; where each treatment cycle was 8 weeks |