MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
NCT ID: NCT05007106
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
613 participants
INTERVENTIONAL
2021-09-16
2025-08-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab/Vibostolimab Co-Formulation
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion every 3 weeks (Q3W) up to 35 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy.
Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Pembrolizumab
Pembrolizumab 200 mg administered via IV infusion Q3W.
Pembrolizumab
Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.
Pembrolizumab
Pembrolizumab 200 mg administered via IV infusion Q3W.
Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort)
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 20 mg once daily (qd) up to 45 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib.
Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Pembrolizumab
Pembrolizumab 200 mg administered via IV infusion Q3W.
Lenvatinib
Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD
Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort)
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 12 mg (body weight \[BW\] ≥60 kg) or lenvatinib 8 mg (BW \<60 kg) qd up to 45 cycles. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Lenvatinib.
Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Pembrolizumab
Pembrolizumab 200 mg administered via IV infusion Q3W.
Lenvatinib
Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD
Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W, plus 5-fluorouracil (5-FU), plus Cisplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with 5-Fluorouracil + Cisplatin.
Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Pembrolizumab
Pembrolizumab 200 mg administered via IV infusion Q3W.
5-Fluorouracil
5-FU 800 mg/m\^2/day administered via continuous IV infusion on each of days 1 to 5 Q3W for up to 35 cycles
Cisplatin
Cisplatin administered via IV infusion
Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus paclitaxel as background therapy until meeting discontinuation criteria. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Paclitaxel.
Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Pembrolizumab
Pembrolizumab 200 mg administered via IV infusion Q3W.
Paclitaxel
Paclitaxel administered via IV infusion at investigator's choice of dose
Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus gemcitabine (until disease progression or unacceptable toxicity) and cisplatin (up to 8 cycles) as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Gemcitabine/Cisplatin
Pembrolizumab
Pembrolizumab 200 mg administered via IV infusion Q3W.
Cisplatin
Cisplatin administered via IV infusion
Gemcitabine
Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity
Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus carboplatin, paclitaxel, and bevacizumab as local standard of care (SOC) background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Carboplatin/Paclitaxel/Bevacizumab.
Pembrolizumab
Pembrolizumab 200 mg administered via IV infusion Q3W.
Paclitaxel
Paclitaxel administered via IV infusion at investigator's choice of dose
Carboplatin
Carboplatin administered via IV infusion at investigator's choice of dose and frequency
Docetaxel
For participants who cannot receive paclitaxel due to hypersensitivity or adverse event (AE), docetaxel administered via IV infusion Q3W, Day 1 of each cycle for up to 5 cycles
Bevacizumab
Bevacizumab (or biosimilars such as MVASI®, Zirabev®, Aybintio®, ALYMSYS®, Abevmy®, Onbevezy®, Vegzelma®) administered via IV infusion Q3W; Day 1 of each 3-week cycle for up to 15 cycles
Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus capecitabine and oxaliplatin as background therapy. Participants receiving pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) will be given the option to transition to pembrolizumab monotherapy in combination with Capecitabine/Oxaliplatin.
Pembrolizumab
Pembrolizumab 200 mg administered via IV infusion Q3W.
Capecitabine
Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles
Oxaliplatin
Oxaliplatin administered via IV infusion Q3W up to 35 cycles
Interventions
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Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
Pembrolizumab
Pembrolizumab 200 mg administered via IV infusion Q3W.
Lenvatinib
Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD
5-Fluorouracil
5-FU 800 mg/m\^2/day administered via continuous IV infusion on each of days 1 to 5 Q3W for up to 35 cycles
Cisplatin
Cisplatin administered via IV infusion
Paclitaxel
Paclitaxel administered via IV infusion at investigator's choice of dose
Gemcitabine
Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity
Carboplatin
Carboplatin administered via IV infusion at investigator's choice of dose and frequency
Docetaxel
For participants who cannot receive paclitaxel due to hypersensitivity or adverse event (AE), docetaxel administered via IV infusion Q3W, Day 1 of each cycle for up to 5 cycles
Bevacizumab
Bevacizumab (or biosimilars such as MVASI®, Zirabev®, Aybintio®, ALYMSYS®, Abevmy®, Onbevezy®, Vegzelma®) administered via IV infusion Q3W; Day 1 of each 3-week cycle for up to 15 cycles
Capecitabine
Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles
Oxaliplatin
Oxaliplatin administered via IV infusion Q3W up to 35 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Active autoimmune disease that has required systemic treatment in past 2 years.
* Active infection requiring systemic therapy.
* Concurrent active hepatitis B and hepatitis C virus infection.
* History of allogenic tissue/solid organ transplant.
* Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm).
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Alaska Womens Cancer Care ( Site 1016)
Anchorage, Alaska, United States
City of Hope Comprehensive Cancer Center ( Site 1001)
Duarte, California, United States
University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
Orange, California, United States
Karmanos Cancer Institute ( Site 1007)
Detroit, Michigan, United States
Memorial Sloan Kettering - Basking Ridge ( Site 1023)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering - Monmouth ( Site 1022)
Middletown, New Jersey, United States
Memorial Sloan Kettering - Bergen ( Site 1025)
Montvale, New Jersey, United States
Memorial Sloan Kettering- Commack ( Site 1021)
Commack, New York, United States
Memorial Sloan Kettering - Westchester ( Site 1020)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 1002)
New York, New York, United States
Memorial Sloan Kettering - Nassau ( Site 1026)
Uniondale, New York, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024)
Tulsa, Oklahoma, United States
Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
Sioux Falls, South Dakota, United States
Houston Methodist Hospital ( Site 1017)
Houston, Texas, United States
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)
Kingston, Ontario, Canada
Princess Margaret Cancer Centre ( Site 1056)
Toronto, Ontario, Canada
FALP-UIDO ( Site 1401)
Santiago, Region M. de Santiago, Chile
Oncovida ( Site 1405)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 1402)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigacion del Cancer ( Site 1404)
Temuco, Región de la Araucanía, Chile
Fundacion Colombiana de Cancerología Clinica Vida ( Site 1422)
Medellín, Antioquia, Colombia
Clinica de la Costa S.A.S. ( Site 1421)
Barranquilla, Atlántico, Colombia
Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)
Bogotá, Cundinamarca, Colombia
Oncologos del Occidente ( Site 1424)
Pereira, Risaralda Department, Colombia
Fundación Cardiovascular de Colombia ( Site 1423)
Piedecuesta, Santander Department, Colombia
CENTRE LEON BERARD-Medical oncology ( Site 1151)
Lyon, Auvergne-Rhône-Alpes, France
Centre Georges François Leclerc ( Site 1155)
Dijon, Cote-d Or, France
Institut Regional du Cancer Montpellier ( Site 1157)
Montpellier, Herault, France
Gustave Roussy-medicine departement ( Site 1153)
Villejuif, Paris, France
Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)
Avignon, Vaucluse, France
Institut Curie ( Site 1152)
Paris, , France
Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne
Tübingen, Baden-Wurttemberg, Germany
Klinikum der Universität München Großhadern ( Site 1176)
München, Bavaria, Germany
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)
Düsseldorf, North Rhine-Westphalia, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)
Berlin, , Germany
Rambam Health Care Campus-Oncology ( Site 1141)
Haifa, , Israel
Hadassah Medical Center-Oncology ( Site 1142)
Jerusalem, , Israel
Sheba Medical Center-ONCOLOGY ( Site 1144)
Ramat Gan, , Israel
Sourasky Medical Center-Oncology ( Site 1143)
Tel Aviv, , Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136)
Rome, Lazio, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1135)
Milan, Lombardy, Italy
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1138)
Rozzano, Milano, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)
Napoli, , Italy
Aichi Cancer Center Hospital ( Site 1324)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 1321)
Kashiwa, Chiba, Japan
Osaka International Cancer Institute ( Site 1323)
Osaka, , Japan
National Cancer Center Hospital ( Site 1322)
Tokyo, , Japan
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1121)
Amsterdam, North Holland, Netherlands
Erasmus Medisch Centrum-Medical Oncology ( Site 1122)
Rotterdam, South Holland, Netherlands
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)
Gdansk, Pomeranian Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)
Koszalin, West Pomeranian Voivodeship, Poland
Seoul National University Hospital-Internal Medicine ( Site 1312)
Seoul, , South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)
Seoul, , South Korea
Asan Medical Center ( Site 1313)
Seoul, , South Korea
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)
Hospitalet, Barcelona, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)
Madrid, Madrid, Comunidad de, Spain
Clinica Universidad de Navarra-Medical Oncology ( Site 1118)
Madrid, , Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)
Seville, , Spain
NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)
Tainan City, , Taiwan
National Taiwan University Hospital-Oncology ( Site 1301)
Taipei, , Taiwan
Mackay Memorial Hospital ( Site 1305)
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 1304)
Taoyuan District, , Taiwan
Istanbul Universitesi Cerrahpasa ( Site 1203)
Istanbul- Fatih, Istanbul, Turkey (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)
Adana, , Turkey (Türkiye)
Hacettepe Universitesi-oncology hospital ( Site 1209)
Ankara, , Turkey (Türkiye)
Ankara City Hospital-Medical Oncology ( Site 1202)
Ankara, , Turkey (Türkiye)
Trakya University-Medical Oncology ( Site 1207)
Edirne, , Turkey (Türkiye)
Acibadem Universitesi Atakent Hastanesi ( Site 1208)
Istanbul, , Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)
Istanbul, , Turkey (Türkiye)
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-7684A-005
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031210335
Identifier Type: REGISTRY
Identifier Source: secondary_id
KEYVIBE-005
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505284-36-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1291-4290
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-001009-56
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7684A-005
Identifier Type: -
Identifier Source: org_study_id
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