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
Sites (83)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Oncología e Investigación de Buenos Aires ( Site 0008) Coordinator of this site? Confirm its status | Berazategui | Argentina | Unknown status |
| Hospital Privado Universitario de Córdoba ( Site 0001) Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0005) Coordinator of this site? Confirm its status | La Rioja | Argentina | Unknown status |
| Hospital Privado de Comunidad ( Site 0004) Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0002) Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Instituto de Oncología de Rosario ( Site 0003) Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Krankenhaus Nord - Klinik Floridsdorf Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Canberra Hospital ( Site 0104) Coordinator of this site? Confirm its status | Canberra | Australia | Unknown status |
| Fiona Stanley Hospital-Medical Oncology ( Site 0102) Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Gold Coast University Hospital-Clinical Trials Service ( Site 0106) Coordinator of this site? Confirm its status | Southport | Australia | Unknown status |
| Grand Hopital de Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Completed |
| A.Z. Sint-Maarten Coordinator of this site? Confirm its status | Mechelen | Belgium | Completed |
| Verenigde Ziekenhuizen van Waas en Durme Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Completed |
| Hospital Nossa Senhora da Conceição ( Site 0403) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Centro de Tratamento de Tumores Botafogo - CTTB-Pesquisa Clínica ( Site 0402) Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Hospital Paulistano ( Site 0406) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0400) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Ospedale Regionale Bellinzona e Valli ( Site 2203) Coordinator of this site? Confirm its status | Bellinzona | Switzerland | Unknown status |
| Helios Klinikum Emil von Behring GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Completed |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Completed |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Completed |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Completed |
| Vaasa Central Hospital Coordinator of this site? Confirm its status | Vaasa | Finland | Completed |
| Centre Hospitalier d'Avignon Coordinator of this site? Confirm its status | Avignon | France | Completed |
| Clinique Ambroise Pare Coordinator of this site? Confirm its status | Beuvry | France | Completed |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Completed |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans Cedex 9 | France | Completed |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Completed |
| Direction Centrale Du Service De Sante Des Armees Coordinator of this site? Confirm its status | Toulon Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| Soroka Medical Center ( Site 1202) Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Rambam Health Care Campus-Oncology ( Site 1203) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Shaare Zedek Medical Center-Oncology ( Site 1206) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sourasky Medical Center ( Site 1205) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| European Institute Of Oncology S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliera dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Completed |
| Azienda Ospedaliera S Giovanni Addolorata Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Chungbuk National University Hospital-Internal medicine ( Site 2004) Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Seoul National University Bundang Hospital ( Site 2003) Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Asan Medical Center-Oncology ( Site 2000) Coordinator of this site? Confirm its status | Songpagu | South Korea | Unknown status |
| The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2005) Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Hospital Sultan Ismail ( Site 1503) Coordinator of this site? Confirm its status | Johor Bahru | Malaysia | Unknown status |
| Hospital Tengku Ampuan Afzan ( Site 1500) Coordinator of this site? Confirm its status | Kuantan | Malaysia | Unknown status |
| University Malaya Medical Centre ( Site 1501) Coordinator of this site? Confirm its status | Lembah Pantai | Malaysia | Unknown status |
| Beacon Hospital Sdn Bhd ( Site 1504) Coordinator of this site? Confirm its status | Petaling Jaya | Malaysia | Unknown status |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Moscow Clinical Research Center-Chemotherapy department ( Site 1910) Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Hadassah Medical-Oncology department ( Site 1912) Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Central Clinical Hospital of the Presidential Administrative Department ( Site 1902) Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 1909) Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary ( Site 1908) Coordinator of this site? Confirm its status | Omsk | Russia | Unknown status |
| GBUZ LOKB-Oncology department #1 ( Site 1905) Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1911) Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov ( Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Chulalongkorn University ( Site 2403) Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Faculty of Medicine Siriraj Hospital ( Site 2400) Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Chang Gung Memorial Hospital at Kaohsiung ( Site 2303) Coordinator of this site? Confirm its status | Kaohsiung Niao Sung Dist | Taiwan | Unknown status |
| Taichung Veterans General Hospital-Chest ( Site 2307) Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 2302) Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital-Oncology ( Site 2304) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Mackay Memorial Hospital-Chest Medicine ( Site 2305) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| University of Maryland ( Site 2528) Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526) Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| St Francis Cancer Center-Research Office ( Site 2531) Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Hattiesburg Clinic Hematology/Oncology ( Site 2511) Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| Baptist Health Lexington-Research ( Site 2502) Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Cedars-Sinai Medical Center ( Site 2522) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Illinois Cancer Care ( Site 2534) Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Mercy Research - Cancer and Hematology Center ( Site 2535) Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Mercy Research - David C. Pratt Cancer Center ( Site 2532) Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509) Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.