A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.

Official Title
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A Phase 1b/2 Study of BMS-986442 in Combination With Nivolumab or Nivolumab and Chemotherapies in Participants With Advanced Solid Tumors and Non-small Cell Lung Cancer

Conditions
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Advanced Solid Tumors, Non-small Cell Lung Cancer

Intervention / Treatment
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* Biological: BMS-986442
* Biological: Nivolumab
* Drug: Docetaxel
* Drug: Carboplatin
* Drug: Pemexetred
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Participants must have a life expectancy of at least 3 months at the time of first dose. Exclusion Criteria: Untreated symptomatic central nervous system metastases or leptomeningeal metastases. Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts. Participants with an active, known, or suspected autoimmune disease. 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: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: BMS-986442 + Nivolumab<br> | Biological: BMS-986442<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|
| Experimental: Part B1: BMS-986442 + Nivolumab<br>Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC) | Biological: BMS-986442<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|
| Experimental: Part B2: BMS-986442 + Nivolumab<br>Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN) | Biological: BMS-986442<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|
| Experimental: Part C: BMS-986442 + Nivolumab + Docetaxel<br> | Biological: BMS-986442<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;Drug: Docetaxel<br>* Specified dose on specified days<br>* Other names: Taxane / Toxotere chemotherapy;|
| Experimental: Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed<br> | Biological: BMS-986442<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;Drug: Carboplatin<br>* Specified dose on specified days<br>* Other names: Platinum chemotherapy;Drug: Pemexetred<br>* Specified dose on specified days<br>* Other names: Folate analog metabolic inhibitor;|
| Experimental: Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel<br> | Biological: BMS-986442<br>* Specified dose on specified days<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;Drug: Carboplatin<br>* Specified dose on specified days<br>* Other names: Platinum chemotherapy;Drug: Paclitaxel<br>* Specified dose on specified days<br>* Other names: Taxane chemotherapy;|

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 119 Weeks | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 119 Weeks | 
| Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria |  | Up to 119 Weeks | 
| Incidence of AEs leading to discontinuation |  | Up to 119 Weeks | 
| Incidence of AEs leading to death |  | Up to 119 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to 119 Weeks | 
| Time of maximum observed concentration (Tmax) |  | Up to 119 Weeks | 
| Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) |  | Up to 119 Weeks | 
| Incidence of Anti-drug Antibodies (ADAs) to BMS-986442 |  | Up to 119 Weeks | 
| Objective Response Rate (ORR) |  | At 6 months and 12 months | 
| Duration of Response (DOR) |  | At 6 months and 12 months | 
| Disease Control Rate (DCR) |  | At 6 months and 12 months | 
| Progression-free Survival Rate (PFSR) |  | At 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986442, Nivolumab, Chemotherapy