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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 1
- Locations
- 68
- Primary Endpoint
- Progression Free Survival by BICR
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm B
Intervention: Nivolumab (Drug)
Arm B
Intervention: Ipilimumab (Drug)
Arm A
Intervention: Nivolumab (Drug)
Arm A
Intervention: Ipilimumab (Drug)
Arm A
Intervention: BMS-986207 (Drug)
Arm B
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Progression Free Survival by BICR
Time Frame: From first dose to progression or death, 2.3 months
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Secondary Outcomes
- Overall Survival (OS)(From randomization to time of death, 2.3 months)
- Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths.(From first dose to progression or death, 2.3 months)
- Overall Response Rate (ORR) by BICR(From first dose to progression or death, 2.3 months)
- Overall Response Rate (ORR) by Investigator(From first dose to progression or death, 2.3 months)
- Progression Free Survival by Investigator(From first dose to progression or death, 2.3 months)
- Duration of Response (DOR) by Investigator(From first dose to progression or death, 2.3 months)