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COMPLETED
NCT05007106
PHASE2

MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

611

Start Date

2021-09-16

Completion Date

2025-08-05

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

Pembrolizumab/Vibostolimab Co-Formulation

Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W

BIOLOGICAL

Pembrolizumab

Pembrolizumab 200 mg administered via IV infusion Q3W.

DRUG

Lenvatinib

Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD

DRUG

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

DRUG

Cisplatin

Cisplatin administered via IV infusion

DRUG

Paclitaxel

Paclitaxel administered via IV infusion at investigator's choice of dose

DRUG

Gemcitabine

Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity

DRUG

Carboplatin

Carboplatin administered via IV infusion at investigator's choice of dose and frequency

DRUG

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

DRUG

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

DRUG

Capecitabine

Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles

DRUG

Oxaliplatin

Oxaliplatin administered via IV infusion Q3W up to 35 cycles

Locations (73)

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

James Lind Centro de Investigacion del Cancer ( Site 1404)

Temuco, Araucania, Chile

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

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)

Naples, 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, 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, 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)