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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
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

Full criteria on ClinicalTrials.gov

Sites (73)

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

SiteCityCountrySite status
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)
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KingstonCanadaUnknown status
Princess Margaret Cancer Centre ( Site 1056)
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TorontoCanadaUnknown status
Bradfordhill-Clinical Area ( Site 1402)
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SantiagoChileUnknown status
FALP-UIDO ( Site 1401)
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SantiagoChileUnknown status
Oncovida ( Site 1405)
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SantiagoChileUnknown status
James Lind Centro de Investigacion del Cancer ( Site 1404)
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TemucoChileUnknown status
Clinica de la Costa S.A.S. ( Site 1421)
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BarranquillaColombiaUnknown status
Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)
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BogotáColombiaUnknown status
Fundacion Colombiana de Cancerología Clinica Vida ( Site 1422)
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MedellínColombiaUnknown status
Oncologos del Occidente ( Site 1424)
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PereiraColombiaUnknown status
Fundación Cardiovascular de Colombia ( Site 1423)
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PiedecuestaColombiaUnknown status
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)
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BerlinGermanyUnknown status
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)
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DüsseldorfGermanyUnknown status
Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)
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HeidelbergGermanyUnknown status
Klinikum der Universität München Großhadern ( Site 1176)
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MünchenGermanyUnknown status
Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne
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TübingenGermanyUnknown status
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)
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HospitaletSpainUnknown status
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)
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MadridSpainUnknown status
Clinica Universidad de Navarra-Medical Oncology ( Site 1118)
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MadridSpainUnknown status
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)
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Pozuelo de AlarcónSpainUnknown status
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)
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SevilleSpainUnknown status
Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)
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AvignonFranceUnknown status
Centre Georges François Leclerc ( Site 1155)
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DijonFranceUnknown status
CENTRE LEON BERARD-Medical oncology ( Site 1151)
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LyonFranceUnknown status
Institut Regional du Cancer Montpellier ( Site 1157)
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MontpellierFranceUnknown status
Institut Curie ( Site 1152)
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ParisFranceUnknown status
Gustave Roussy-medicine departement ( Site 1153)
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VillejuifFranceUnknown status
Rambam Health Care Campus-Oncology ( Site 1141)
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HaifaIsraelUnknown status
Hadassah Medical Center-Oncology ( Site 1142)
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JerusalemIsraelUnknown status
Sheba Medical Center-ONCOLOGY ( Site 1144)
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Ramat GanIsraelUnknown status
Sourasky Medical Center-Oncology ( Site 1143)
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Tel AvivIsraelUnknown status
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
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MilanItalyUnknown status
Ospedale San Raffaele-Oncologia Medica ( Site 1135)
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MilanItalyUnknown status
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)
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NaplesItalyUnknown status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136)
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RomeItalyUnknown status
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1138)
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RozzanoItalyUnknown status
National Cancer Center Hospital East ( Site 1321)
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KashiwaJapanUnknown status
Aichi Cancer Center Hospital ( Site 1324)
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NagoyaJapanUnknown status
Osaka International Cancer Institute ( Site 1323)
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OsakaJapanUnknown status
National Cancer Center Hospital ( Site 1322)
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TokyoJapanUnknown status
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)
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SeoulSouth KoreaUnknown status
Seoul National University Hospital-Internal Medicine ( Site 1312)
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SeoulSouth KoreaUnknown status
Asan Medical Center ( Site 1313)
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SeoulSouth KoreaUnknown status
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1121)
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AmsterdamNetherlandsUnknown status
Erasmus Medisch Centrum-Medical Oncology ( Site 1122)
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RotterdamNetherlandsUnknown status
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)
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GdanskPolandUnknown status
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)
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KoszalinPolandUnknown status
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101
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WarsawPolandUnknown status
NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)
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TainanTaiwanUnknown status
Mackay Memorial Hospital ( Site 1305)
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TaipeiTaiwanUnknown status
National Taiwan University Hospital-Oncology ( Site 1301)
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation-Linkou Branch ( Site 1304)
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TaoyuanTaiwanUnknown status
Alaska Womens Cancer Care ( Site 1016)
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AnchorageUnited StatesUnknown status
Memorial Sloan Kettering - Basking Ridge ( Site 1023)
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Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering- Commack ( Site 1021)
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CommackUnited StatesUnknown status
Karmanos Cancer Institute ( Site 1007)
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DetroitUnited StatesUnknown status
City of Hope Comprehensive Cancer Center ( Site 1001)
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DuarteUnited StatesUnknown status
Memorial Sloan Kettering - Westchester ( Site 1020)
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HarrisonUnited StatesUnknown status
Houston Methodist Hospital ( Site 1017)
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HoustonUnited StatesUnknown status
Memorial Sloan Kettering - Monmouth ( Site 1022)
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MiddletownUnited StatesUnknown status
Memorial Sloan Kettering - Bergen ( Site 1025)
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MontvaleUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center ( Site 1002)
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New YorkUnited StatesUnknown status
University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
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OrangeUnited StatesUnknown status
Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
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Sioux FallsUnited StatesUnknown status
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024)
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TulsaUnited StatesUnknown status
Memorial Sloan Kettering - Nassau ( Site 1026)
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UniondaleUnited StatesUnknown status
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)
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AdanaTurkey (Türkiye)Unknown status
Ankara City Hospital-Medical Oncology ( Site 1202)
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AnkaraTurkey (Türkiye)Unknown status
Hacettepe Universitesi-oncology hospital ( Site 1209)
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AnkaraTurkey (Türkiye)Unknown status
Trakya University-Medical Oncology ( Site 1207)
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EdirneTurkey (Türkiye)Unknown status
Acibadem Universitesi Atakent Hastanesi ( Site 1208)
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IstanbulTurkey (Türkiye)Unknown status
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)
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IstanbulTurkey (Türkiye)Unknown status
Istanbul Universitesi Cerrahpasa ( Site 1203)
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Istanbul- FatihTurkey (Türkiye)Unknown status

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