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)

  • Interventional
  • Recruiting
  • NCT05226598
Eligibility Details Visit

A Randomized, Double-Blind, Phase 3 Study of MK-7684A in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer

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 treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).


Age Group
18 Years and up

Accepting Healthy Volunteers?

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 vibostolimab, 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 (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.

         - 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.

At a Glance

National Government IDNCT05226598


Lead SponsorMerck Sharp & Dohme LLC

Lead PhysicianMarina Chiara Garassino


18 Years and up