CompletedPhase 2NCT05005273

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

StatusCompleted
PhasePhase 2
U.S. locations71
SponsorBristol-Myers Squibb
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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