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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Ipilimumab; Other: Placebo; Drug: BMS-986207; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05005273

2021-000039-29 (EudraCT Number)

U1111-1263-4850 (Other Identifier)

CA020-016

Details and patient eligibility

About

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).

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Drug: Nivolumab

Drug: BMS-986207

Drug: Ipilimumab

Arm B

Experimental group

Treatment:

Drug: Nivolumab

Other: Placebo

Drug: Ipilimumab