Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.
Checked against the public recordLast updated Feb 5, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Merck Sharp & Dohme LLC
- Interventions being studied
- Biological: Pembrolizumab/Vibostolimab; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Pemetrexed; Biological: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC * Has not received prior systemic treatment for metastatic NSCLC * Has measurable disease based on RECIST 1.1, as determined by the local site assessment * Has a life expectancy of at least 3 months * Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method Exclusion Criteria: * Known additional malignancy that is progressing or has required active treatment within the past 3 years * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Severe hypersensitivity to MK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its excipients * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication * Active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has an active infection requiring systemic therapy * Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus * Received prior systemic anticancer therapy for metastatic disease * Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed * History of allogeneic tissue/solid organ transplant * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam) * Is unable or unwilling to take folic acid or vitamin B12 supplementation * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCHealth Memorial Hospital-Heme Onc ( Site 0003)Colorado Springs, Colorado
- University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)Fort Collins, Colorado
- Mayo Clinic in Florida ( Site 0022)Jacksonville, Florida
- Mount Sinai Hospital ( Site 0011)Chicago, Illinois
- University of Chicago Medical Center ( Site 0015)Chicago, Illinois
- New England Cancer Specialists ( Site 0008)Scarborough, Maine
- Cancer and Hematology Centers of Western Michigan ( Site 0002)Grand Rapids, Michigan
- Mayo Clinic in Rochester, Minnesota ( Site 0030)Rochester, Minnesota
- Stony Brook University-Cancer Center ( Site 0013)Stony Brook, New York
- Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)Lancaster, Pennsylvania
- Charleston Oncology ( Site 0019)Charleston, South Carolina
- University of Virginia Cancer Center ( Site 0018)Charlottesville, Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 5, 2026. Always confirm current availability with the study team.