A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.

Official Title
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Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors

Conditions
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Broad Solid Tumor

Intervention / Treatment
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* Drug: BMS-986207
* Biological: Nivolumab
* Biological: Ipilimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization Exclusion Criteria: Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll Other active malignancy requiring concurrent intervention Uncontrolled or significant cardiovascular disease Active, known, or suspected autoimmune disease NSCLC without prior treatment in the advanced or metastatic setting (Part 2C) Other protocol-defined inclusion/exclusion criteria apply

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: Part 1A: Dose Escalation Monotherapy<br> | Drug: BMS-986207<br>* Specified dose on specified days<br>|
| Experimental: Part 1B: Dose Escalation Combination Therapy<br> | Drug: BMS-986207<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;|
| Experimental: Part 2A: Expansion Monotherapy<br> | Drug: BMS-986207<br>* Specified dose on specified days<br>|
| Experimental: Part 2B: Expansion Combination Therapy<br> | Drug: BMS-986207<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;|
| Experimental: Part 1C: Triplet Cohort<br> | Drug: BMS-986207<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Biological: Ipilimumab<br>* Specified dose on specified days<br>* Other names: Yervoy;|
| Experimental: Part 2C: Triplet Expansion<br> | Drug: BMS-986207<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo;Biological: Ipilimumab<br>* Specified dose on specified days<br>* Other names: Yervoy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 27 months | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 27 months | 
| Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria |  | Up to 6 weeks | 
| Incidence of AEs leading to discontinuation |  | Up to 27 months | 
| Incidence of deaths |  | Up to 27 months | 
| Number of participants with laboratory abnormalities |  | Up to 27 months | 
| Objective response rate (ORR) |  | Up to 36 months | 
| Median duration of response (mDOR) |  | Up to 36 months | 
| Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator |  | At 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) |  | Up to 36 months | 
| Median duration of response (mDOR) |  | Up to 36 months | 
| Progression-free survival rate (PFSR) at 24 weeks by RECIST v1.1 |  | At 24 Weeks | 
| Maximum observed serum concentration (Cmax) |  | Up to 27 months | 
| Time of maximum observed serum concentration (Tmax) |  | Up to 27 months | 
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T) |  | Up to 27 months | 
| Incidence of anti-drug antibody (ADA) |  | Up to 27 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First line NSCLC