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
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).
Checked against the public recordLast updated Feb 28, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Drug: Nivolumab; Drug: Ipilimumab; Drug: BMS-986207; Other: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Local Institution - 0080Tucson, Arizona
- Local Institution - 0051Fountain Valley, California
- Local Institution - 0070Fort Myers, Florida
- Local Institution - 0073Gainesville, Florida
- Local Institution - 0036Orange City, Florida
- Local Institution - 0045Pensacola, Florida
- Local InstitutionPort Saint Lucie, Florida
- Local Institution - 0068St. Petersburg, Florida
- Local InstitutionTallahassee, Florida
- Local InstitutionWest Palm Beach, Florida
- Local Institution - 0081Boise, Idaho
- Local Institution - 0077Coeur d'Alene, Idaho
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 28, 2024. Always confirm current availability with the study team.