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NCT04725188CompletedPhase 2

Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)

A Phase 2, Multicenter, Randomized Study to Compare the Efficacy and Safety of MK-7684A or MK-7684A Plus Docetaxel Versus Docetaxel Monotherapy in the Treatment of Participants With Metastatic Non-small Cell Lung Cancer With Progressive Disease After Treatment With a Platinum Doublet Chemotherapy and Immunotherapy

Source: ClinicalTrials.gov · Last updated 15 Aug 2025

Brief summary (registry, in English)

The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
255 (actual)
First submitted
25 Jan 2021
Start date
20 Apr 2021
Primary completion date
26 Jan 2023
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
Lung cancer
NCT number
NCT04725188
EU CT number
2022-501252-28-00
EudraCT number
2020-004034-38

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 255
  • From 20 Apr 2021 to the primary completion date, 26 Jan 2023
  • 83 sites in 20 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has received docetaxel as monotherapy or in combination with other therapies
  • Has received previous treatment with another agent targeting the T-cell immunoreceptor with immunoglobulin \[Ig\] and immunoreceptor tyrosine-based inhibitory motif \[ITIM\] domains (TIGIT) pathway
  • Has received radiotherapy within 2 weeks of start of study intervention. One week washout is permitted for palliative radiation to non-CNS disease
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Is 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
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention
  • Has had an allogenic tissue/solid organ transplant

Other illness

  • Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy
  • Has severe hypersensitivity (≥Grade 3) to docetaxel or pembrolizumab/vibostolimab coformulation and/or any of its excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has interstitial lung disease, or history of pneumonitis requiring steroids for treatment
  • Has known history of active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

Other

  • Has known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis

Who the study is looking for

  • Has a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
  • Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or reactive oxygen species (ROS) 1 directed therapy is not indicated as primary therapy
  • Has progressive disease (PD) on treatment with one prior anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies
    • Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overall course of treatment
  • Has PD as determined by the investigator after platinum doublet chemotherapy for metastatic disease
  • Has measurable disease defined as at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI), based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
  • Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Has a life expectancy of at least 3 months
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days prior to randomization
  • Male participants randomized to docetaxel are eligible to participant if they agree to refrain from donating sperm, and either 1) be abstinent from heterosexual intercourse; or 2) must agree to follow contraceptive guidance as per study protocol unless confirmed to be azoospermic during the intervention period and for at least 180 days after the last dose of docetaxel
  • Female participants must be not pregnant, not breastfeeding, and not be a woman of child-bearing potential (WOCBP). A WOCBP is eligible is she agrees to either use contraception, or be abstinent from heterosexual intercourse during the intervention period and for ≥120 days after the last dose of study intervention. If a WOCBP is randomized to docetaxel, she agrees not to donate eggs and either uses contraception or be abstinent from heterosexual intercourse during the treatment period and for ≥180 days after the last dose of docetaxel
  • Has adequate organ function

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (83)

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

SiteCityCountrySite status
Centro de Oncología e Investigación de Buenos Aires ( Site 0008)
Coordinator of this site? Confirm its status
BerazateguiArgentinaUnknown status
Hospital Privado Universitario de Córdoba ( Site 0001)
Coordinator of this site? Confirm its status
CórdobaArgentinaUnknown status
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0005)
Coordinator of this site? Confirm its status
La RiojaArgentinaUnknown status
Hospital Privado de Comunidad ( Site 0004)
Coordinator of this site? Confirm its status
Mar del PlataArgentinaUnknown status
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0002)
Coordinator of this site? Confirm its status
Mar del PlataArgentinaUnknown status
Instituto de Oncología de Rosario ( Site 0003)
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Krankenhaus Nord - Klinik Floridsdorf
Coordinator of this site? Confirm its status
ViennaAustriaCompleted
Canberra Hospital ( Site 0104)
Coordinator of this site? Confirm its status
CanberraAustraliaUnknown status
Fiona Stanley Hospital-Medical Oncology ( Site 0102)
Coordinator of this site? Confirm its status
MurdochAustraliaUnknown status
Gold Coast University Hospital-Clinical Trials Service ( Site 0106)
Coordinator of this site? Confirm its status
SouthportAustraliaUnknown status
Grand Hopital de Charleroi
Coordinator of this site? Confirm its status
CharleroiBelgiumCompleted
A.Z. Sint-Maarten
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MechelenBelgiumCompleted
Verenigde Ziekenhuizen van Waas en Durme
Coordinator of this site? Confirm its status
Sint-NiklaasBelgiumCompleted
Hospital Nossa Senhora da Conceição ( Site 0403)
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Centro de Tratamento de Tumores Botafogo - CTTB-Pesquisa Clínica ( Site 0402)
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilUnknown status
Hospital Paulistano ( Site 0406)
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0400)
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Ospedale Regionale Bellinzona e Valli ( Site 2203)
Coordinator of this site? Confirm its status
BellinzonaSwitzerlandUnknown status
Helios Klinikum Emil von Behring GmbH
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Rigshospitalet
Coordinator of this site? Confirm its status
Copenhagen OeDenmarkCompleted
Odense University Hospital
Coordinator of this site? Confirm its status
Odense CDenmarkCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario Virgen De Valme
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SevillaSpainCompleted
Oulu University Hospital
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OuluFinlandCompleted
Tampere University Hospital
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TampereFinlandCompleted
Turku University Hospital
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TurkuFinlandCompleted
Vaasa Central Hospital
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VaasaFinlandCompleted
Centre Hospitalier d'Avignon
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AvignonFranceCompleted
Clinique Ambroise Pare
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BeuvryFranceCompleted
Institut Bergonie
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BordeauxFranceCompleted
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceCompleted
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceCompleted
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceCompleted
Direction Centrale Du Service De Sante Des Armees
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Toulon Cedex 9FranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
Institut Gustave Roussy
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VillejuifFranceCompleted
Soroka Medical Center ( Site 1202)
Coordinator of this site? Confirm its status
BeershebaIsraelUnknown status
Rambam Health Care Campus-Oncology ( Site 1203)
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HaifaIsraelUnknown status
Shaare Zedek Medical Center-Oncology ( Site 1206)
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JerusalemIsraelUnknown status
Sourasky Medical Center ( Site 1205)
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Tel AvivIsraelUnknown status
Careggi University Hospital
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FlorenceItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
European Institute Of Oncology S.r.l.
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MilanItalyCompleted
Azienda Ospedaliera dei Colli
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NaplesItalyCompleted
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyCompleted
Azienda Ospedaliera S Giovanni Addolorata
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RomeItalyCompleted
Chungbuk National University Hospital-Internal medicine ( Site 2004)
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Cheongju-siSouth KoreaUnknown status
Seoul National University Bundang Hospital ( Site 2003)
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SeongnamSouth KoreaUnknown status
Asan Medical Center-Oncology ( Site 2000)
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SongpaguSouth KoreaUnknown status
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2005)
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SuwonSouth KoreaUnknown status
Hospital Sultan Ismail ( Site 1503)
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Johor BahruMalaysiaUnknown status
Hospital Tengku Ampuan Afzan ( Site 1500)
Coordinator of this site? Confirm its status
KuantanMalaysiaUnknown status
University Malaya Medical Centre ( Site 1501)
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Lembah PantaiMalaysiaUnknown status
Beacon Hospital Sdn Bhd ( Site 1504)
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Petaling JayaMalaysiaUnknown status
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Moscow Clinical Research Center-Chemotherapy department ( Site 1910)
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MoscowRussiaUnknown status
Hadassah Medical-Oncology department ( Site 1912)
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MoscowRussiaUnknown status
Central Clinical Hospital of the Presidential Administrative Department ( Site 1902)
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MoscowRussiaUnknown status
Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 1909)
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Nizhny NovgorodRussiaUnknown status
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary ( Site 1908)
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OmskRussiaUnknown status
GBUZ LOKB-Oncology department #1 ( Site 1905)
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Saint PetersburgRussiaUnknown status
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1911)
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Saint PetersburgRussiaUnknown status
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S
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Saint PetersburgRussiaUnknown status
Chulalongkorn University ( Site 2403)
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BangkokThailandUnknown status
Faculty of Medicine Siriraj Hospital ( Site 2400)
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BangkokThailandUnknown status
Chang Gung Memorial Hospital at Kaohsiung ( Site 2303)
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Kaohsiung Niao Sung DistTaiwanUnknown status
Taichung Veterans General Hospital-Chest ( Site 2307)
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TaichungTaiwanUnknown status
NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 2302)
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TainanTaiwanUnknown status
National Taiwan University Hospital-Oncology ( Site 2304)
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TaipeiTaiwanUnknown status
Mackay Memorial Hospital-Chest Medicine ( Site 2305)
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TaipeiTaiwanUnknown status
University of Maryland ( Site 2528)
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BaltimoreUnited StatesUnknown status
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526)
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CincinnatiUnited StatesUnknown status
St Francis Cancer Center-Research Office ( Site 2531)
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GreenvilleUnited StatesUnknown status
Hattiesburg Clinic Hematology/Oncology ( Site 2511)
Coordinator of this site? Confirm its status
HattiesburgUnited StatesUnknown status
Baptist Health Lexington-Research ( Site 2502)
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LexingtonUnited StatesUnknown status
Cedars-Sinai Medical Center ( Site 2522)
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Los AngelesUnited StatesUnknown status
Illinois Cancer Care ( Site 2534)
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PeoriaUnited StatesUnknown status
Mercy Research - Cancer and Hematology Center ( Site 2535)
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SpringfieldUnited StatesUnknown status
Mercy Research - David C. Pratt Cancer Center ( Site 2532)
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St LouisUnited StatesUnknown status
Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509)
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The BronxUnited StatesUnknown status

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