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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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
Coordinator of this site? Confirm its status
GrazAustriaCompleted
Medizinische Universitaet Innsbruck
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InnsbruckAustriaCompleted
Ordensklinikum Linz GmbH
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LinzAustriaCompleted
Krankenhaus Nord - Klinik Floridsdorf
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ViennaAustriaCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH
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DortmundGermanyCompleted
SRH Wald-Klinikum Gera GmbH
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GeraGermanyCompleted
Justus-Liebig-Universitaet Giessen
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GiessenGermanyCompleted
Universitaetsklinikum Schleswig-Holstein
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LübeckGermanyCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainCompleted
Hospital Clínico San Carlos
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MadridSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainCompleted
Institut de Cancerologie de L'Ouest
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AngersFranceCompleted
Centre Hospitalier d'Avignon
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AvignonFranceCompleted
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
HIA Sainte Anne
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Toulon Cedex 9FranceCompleted
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandCompleted
Przychodnia Lekarska Komed Roman Karaszewski
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KoninPolandCompleted
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
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PeremyshlPolandCompleted
Med Polonia Sp z o.o.
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PoznanPolandCompleted
Szpital Specjalistyczny w Prabutach Sp. z o.o.
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PrabutyPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
Centrum Pulmonologii I Torakochirurgii W Bystrej
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WilkowicePolandCompleted

This page is information, not medical advice. Discuss any trial with your doctor.