Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Metastatic Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Effective as of Amendment 5, Participants receiving coformulation of pembrolizumab/vibostolimab plus chemotherapy will be transitioned to standard of care (SOC, pembrolizumab plus chemotherapy). Parti...
Eligibility Criteria
Inclusion
- The main inclusion and exclusion criteria include but are not limited to the following:
- 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
- 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
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2026
Estimated Enrollment :
739 Patients enrolled
Trial Details
Trial ID
NCT05226598
Start Date
March 24 2022
End Date
January 9 2026
Last Update
November 13 2025
Active Locations (149)
Enter a location and click search to find clinical trials sorted by distance.
1
UCHealth Memorial Hospital-Heme Onc ( Site 0003)
Colorado Springs, Colorado, United States, 80909
2
University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)
Fort Collins, Colorado, United States, 80528
3
Mayo Clinic in Florida ( Site 0022)
Jacksonville, Florida, United States, 32224
4
Mount Sinai Hospital ( Site 0011)
Chicago, Illinois, United States, 60608