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)
Completed · Phase 3
Conditions studied: Metastatic Non-Small Cell Lung Cancer
In brief
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%.
Key facts
- Study ID
- NCT05226598
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 739
- Starts
- 2022-03-24
- Expected to finish
- 2026-01-09
- Last updated by the study team
- 2026-02-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031) — Fort Collins, Colorado, United States
- Mayo Clinic in Florida ( Site 0022) — Jacksonville, Florida, United States
- Mount Sinai Hospital ( Site 0011) — Chicago, Illinois, United States
- University of Chicago Medical Center ( Site 0015) — Chicago, Illinois, United States
- New England Cancer Specialists ( Site 0008) — Scarborough, Maine, United States
- Cancer and Hematology Centers of Western Michigan ( Site 0002) — Grand Rapids, Michigan, United States
- Mayo Clinic in Rochester, Minnesota ( Site 0030) — Rochester, Minnesota, United States
- Stony Brook University-Cancer Center ( Site 0013) — Stony Brook, New York, United States
- Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012) — Lancaster, Pennsylvania, United States
- Charleston Oncology ( Site 0019) — Charleston, South Carolina, United States
- University of Virginia Cancer Center ( Site 0018) — Charlottesville, Virginia, United States
- Centro de Oncología e Investigación de Buenos Aires ( Site 0203) — Berazategui, Buenos Aires, Argentina
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204) — Mar del Plata, Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209) — ABB, Buenos Aires F.D., Argentina
- Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202) — Buenos Aires, Buenos Aires F.D., Argentina
- Sanatorio Parque ( Site 0205) — Rosario, Santa Fe Province, Argentina
- Hospital Provincial del Centenario ( Site 0212) — Rosario, Santa Fe Province, Argentina
- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206) — La Rioja, Argentina
- Klinik Penzing-2. Lungenabteilung ( Site 0702) — Vienna, State of Vienna, Austria
- Medizinische Universität Graz ( Site 0704) — Graz, Styria, Austria
- Medizinische Universitaet Innsbruck ( Site 0703) — Innsbruck, Tyrol, Austria
- Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705) — Linz, Upper Austria, Austria
- Kepler Universitätsklinikum ( Site 0707) — Linz, Upper Austria, Austria
- Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0701) — Vienna, Austria
- UCHealth Memorial Hospital-Heme Onc ( Site 0003) — Colorado Springs, Colorado, United States
Full record on ClinicalTrials.gov
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