A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and efficacy of BMS-986207 in combination with nivolumab and ipilimumab as first-line treatment for participants with stage IV non-small cell lung cancer (NSCLC).

Official Title
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A Phase 2 Randomized Study of BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Nivolumab
* Drug: Ipilimumab
* Drug: BMS-986207
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed metastatic 1L Stage IV non-small cell lung cancer (NSCLC) of squamous or nonsquamous histology No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic NSCLC Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Eastern Cooperative Oncology Group (ECOG) performance status 0-1 A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 20 unstained slides of tumor tissue obtained during screening or prior to enrollment Life expectancy of at least 3 months at the time of first dose Exclusion Criteria: Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutations which are sensitive to available targeted inhibitor therapy. Participants with nonsquamous histology and unknown EGFR, ALK, or ROS-1 status are also excluded Participants with known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF) V600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible. Untreated central nervous system metastases Leptomeningeal metastases (carcinomatous meningitis) Concurrent malignancy requiring treatment Active, known, or suspected autoimmune disease Interstitial lung disease Uncontrolled or significant cardiovascular 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-963558;Drug: Ipilimumab<br>* Specified dose on specified days<br>* Other names: BMS-734016;Drug: BMS-986207<br>* Specified dose on specified days<br>|
| Experimental: Arm B<br> | Drug: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-963558;Drug: Ipilimumab<br>* Specified dose on specified days<br>* Other names: BMS-734016;Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR) |  | Up to 25 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS based on RECIST v1.1 by BICR |  | Up to 25 months | 
| Incidence of adverse events (AEs) |  | Up to 4 years | 
| Incidence of serious adverse events (SAEs) |  | Up to 4 years | 
| Incidence of AEs leading to discontinuation |  | Up to 4 years | 
| Incidence of deaths |  | Up to 4 years | 
| Objective response rate (ORR) based on RECIST v1.1 by BICR |  | Up to 25 months | 
| Overall Survival (OS) |  | Up to 30 months | 
| PFS based on RECIST v1.1 by Investigator's assessment |  | Up to 25 months | 
| PFS in subgroups based on RECIST v1.1 by BICR |  | Up to 25 months | 
| PFS in subgroups based on RECIST v1.1 by investigator's assessment |  | Up to 25 months | 
| ORR based on RECIST v1.1 by Investigator's assessment |  | Up to 25 months | 
| Duration of Response (DOR) based on RECIST v1.1 by BICR |  | Up to 25 months | 
| DOR based on RECIST v1.1 by Investigator's assessment |  | Up to 25 months | 
| OS in subgroups |  | Up to 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ipilimumab, Non-Small Cell Lung Cancer, NSCLC, BMS-986207, Nivolumab, Opdivo, Yervoy