NCT05007106CompletedPhase 2
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 611 (actual)
- First submitted
- 10 Aug 2021
- Start date
- 16 Sept 2021
- Primary completion date
- 5 Aug 2025
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Triple-negative breast cancer, Head and neck cancer, Bladder cancer, Cervical cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT05007106
- EU CT number
- 2023-505284-36-00
- EudraCT number
- 2021-001009-56
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 611
- From 16 Sept 2021 to the primary completion date, 5 Aug 2025
- 73 sites in 15 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
- Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent.
- Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- 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 medication.
- Concurrent active hepatitis B and hepatitis C virus infection.
- Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm).
Other illness
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
- Active autoimmune disease that has required systemic treatment in past 2 years.
- Active infection requiring systemic therapy.
- History of allogenic tissue/solid organ transplant.
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
Who the study is looking for
- One of the following histologically or cytologically confirmed, advanced (unresectable or metastatic) solid tumors:
- Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
- Endometrial cancer
- Head and neck squamous cell carcinoma (HNSCC)
- Unresectable biliary adenocarcinoma (gallbladder or biliary tree \[intrahepatic or extrahepatic\] cholangiocarcinoma)
- Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ).
- Triple-negative breast cancer (TNBC)
- Hepatocellular carcinoma (HCC)
- Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
- Ovarian cancer
- Gastric cancer
- Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator.
- Adequately controlled blood pressure (BP) with or without antihypertensive medications.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
- Male participants must agree to follow contraceptive guidance.
- Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance.
- Adequate organ function.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (73)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051) Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| Princess Margaret Cancer Centre ( Site 1056) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Bradfordhill-Clinical Area ( Site 1402) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| FALP-UIDO ( Site 1401) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Oncovida ( Site 1405) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| James Lind Centro de Investigacion del Cancer ( Site 1404) Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| Clinica de la Costa S.A.S. ( Site 1421) Coordinator of this site? Confirm its status | Barranquilla | Colombia | Unknown status |
| Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425) Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| Fundacion Colombiana de Cancerología Clinica Vida ( Site 1422) Coordinator of this site? Confirm its status | Medellín | Colombia | Unknown status |
| Oncologos del Occidente ( Site 1424) Coordinator of this site? Confirm its status | Pereira | Colombia | Unknown status |
| Fundación Cardiovascular de Colombia ( Site 1423) Coordinator of this site? Confirm its status | Piedecuesta | Colombia | Unknown status |
| Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171) Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172) Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180) Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Klinikum der Universität München Großhadern ( Site 1176) Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113) Coordinator of this site? Confirm its status | Hospitalet | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clinica Universidad de Navarra-Medical Oncology ( Site 1118) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117) Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Unknown status |
| HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114) Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156) Coordinator of this site? Confirm its status | Avignon | France | Unknown status |
| Centre Georges François Leclerc ( Site 1155) Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CENTRE LEON BERARD-Medical oncology ( Site 1151) Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Institut Regional du Cancer Montpellier ( Site 1157) Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Institut Curie ( Site 1152) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Gustave Roussy-medicine departement ( Site 1153) Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Rambam Health Care Campus-Oncology ( Site 1141) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center-Oncology ( Site 1142) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba Medical Center-ONCOLOGY ( Site 1144) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Sourasky Medical Center-Oncology ( Site 1143) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative ( Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedale San Raffaele-Oncologia Medica ( Site 1135) Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134) Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136) Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1138) Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
| National Cancer Center Hospital East ( Site 1321) Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Aichi Cancer Center Hospital ( Site 1324) Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Osaka International Cancer Institute ( Site 1323) Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| National Cancer Center Hospital ( Site 1322) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital-Internal Medicine ( Site 1312) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center ( Site 1313) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1121) Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Erasmus Medisch Centrum-Medical Oncology ( Site 1122) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103) Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104) Coordinator of this site? Confirm its status | Koszalin | Poland | Unknown status |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101 Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302) Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Mackay Memorial Hospital ( Site 1305) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital-Oncology ( Site 1301) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Medical Foundation-Linkou Branch ( Site 1304) Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Alaska Womens Cancer Care ( Site 1016) Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| Memorial Sloan Kettering - Basking Ridge ( Site 1023) Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering- Commack ( Site 1021) Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Karmanos Cancer Institute ( Site 1007) Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| City of Hope Comprehensive Cancer Center ( Site 1001) Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Memorial Sloan Kettering - Westchester ( Site 1020) Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Houston Methodist Hospital ( Site 1017) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Memorial Sloan Kettering - Monmouth ( Site 1022) Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan Kettering - Bergen ( Site 1025) Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center ( Site 1002) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Sanford Cancer Center-Gynecologic Oncology ( Site 1015) Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024) Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Memorial Sloan Kettering - Nassau ( Site 1026) Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
| Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201) Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Ankara City Hospital-Medical Oncology ( Site 1202) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Hacettepe Universitesi-oncology hospital ( Site 1209) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Trakya University-Medical Oncology ( Site 1207) Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| Acibadem Universitesi Atakent Hastanesi ( Site 1208) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Istanbul Universitesi Cerrahpasa ( Site 1203) Coordinator of this site? Confirm its status | Istanbul- Fatih | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.