NCT05226598CompletedPhase 3
Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants with Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants with Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Dec 2025
Brief summary (registry, in English)
1. To compare MK-7684A in combination with chemotherapy to pembrolizumab in combination with chemotherapy with respect to Overall Survival (OS) in participants with PD-L1 TPS ≥1%
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 190 (actual)
- First submitted
- 1 Sept 2023
- Start date
- 22 Mar 2022
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Lung cancer
- NCT number
- NCT05226598
- EU CT number
- 2023-506074-12-00
- EudraCT number
- 2021-004564-94
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 190
- 27 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- 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).
- 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.
- 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.
- Received prior systemic anticancer therapy for metastatic disease.
Other illness
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- History of allogeneic tissue/solid organ transplant.
- Severe hypersensitivity to MK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its excipients.
- 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.
Other
- Is unable or unwilling to take folic acid or vitamin B12 supplementation.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Completed |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Completed |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Completed |
| Krankenhaus Nord - Klinik Floridsdorf Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH Coordinator of this site? Confirm its status | Dortmund | Germany | Completed |
| SRH Wald-Klinikum Gera GmbH Coordinator of this site? Confirm its status | Gera | Germany | Completed |
| Justus-Liebig-Universitaet Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Completed |
| Universitaetsklinikum Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Completed |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Institut de Cancerologie de L'Ouest Coordinator of this site? Confirm its status | Angers | France | Completed |
| Centre Hospitalier d'Avignon Coordinator of this site? Confirm its status | Avignon | France | Completed |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Completed |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| HIA Sainte Anne Coordinator of this site? Confirm its status | Toulon Cedex 9 | France | Completed |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Przychodnia Lekarska Komed Roman Karaszewski Coordinator of this site? Confirm its status | Konin | Poland | Completed |
| Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu Coordinator of this site? Confirm its status | Peremyshl | Poland | Completed |
| Med Polonia Sp z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Szpital Specjalistyczny w Prabutach Sp. z o.o. Coordinator of this site? Confirm its status | Prabuty | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Centrum Pulmonologii I Torakochirurgii W Bystrej Coordinator of this site? Confirm its status | Wilkowice | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.