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
Who is this study for? Patients with selected solid tumors
What treatments are being studied? Pembrolizumab+Vibostolimab
Status: Completed
Location: See all (73) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alaska
Alaska Womens Cancer Care ( Site 1016)
Anchorage
California
City of Hope Comprehensive Cancer Center ( Site 1001)
Duarte
University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
Orange
Michigan
Karmanos Cancer Institute ( Site 1007)
Detroit
New Jersey
Memorial Sloan Kettering - Basking Ridge ( Site 1023)
Basking Ridge
Memorial Sloan Kettering - Monmouth ( Site 1022)
Middletown
Memorial Sloan Kettering - Bergen ( Site 1025)
Montvale
New York
Memorial Sloan Kettering- Commack ( Site 1021)
Commack
Memorial Sloan Kettering - Westchester ( Site 1020)
Harrison
Memorial Sloan Kettering Cancer Center ( Site 1002)
New York
Memorial Sloan Kettering - Nassau ( Site 1026)
Uniondale
Oklahoma
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1024)
Tulsa
South Dakota
Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
Sioux Falls
Texas
Houston Methodist Hospital ( Site 1017)
Houston
Other Locations
Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)
Kingston
Princess Margaret Cancer Centre ( Site 1056)
Toronto
Chile
Bradfordhill-Clinical Area ( Site 1402)
Santiago
FALP-UIDO ( Site 1401)
Santiago
Oncovida ( Site 1405)
Santiago
James Lind Centro de Investigacion del Cancer ( Site 1404)
Temuco
Colombia
Clinica de la Costa S.A.S. ( Site 1421)
Barranquilla
Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)
Bogotá
Fundacion Colombiana de Cancerología Clinica Vida ( Site 1422)
Medellín
Oncologos del Occidente ( Site 1424)
Pereira
Fundación Cardiovascular de Colombia ( Site 1423)
Piedecuesta
France
Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)
Avignon
Centre Georges François Leclerc ( Site 1155)
Dijon
CENTRE LEON BERARD-Medical oncology ( Site 1151)
Lyon
Institut Regional du Cancer Montpellier ( Site 1157)
Montpellier
Institut Curie ( Site 1152)
Paris
Gustave Roussy-medicine departement ( Site 1153)
Villejuif
Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)
Berlin
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)
Düsseldorf
Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)
Heidelberg
Klinikum der Universität München Großhadern ( Site 1176)
München
Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne
Tübingen
Israel
Rambam Health Care Campus-Oncology ( Site 1141)
Haifa
Hadassah Medical Center-Oncology ( Site 1142)
Jerusalem
Sheba Medical Center-ONCOLOGY ( Site 1144)
Ramat Gan
Sourasky Medical Center-Oncology ( Site 1143)
Tel Aviv
Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
Milan
Ospedale San Raffaele-Oncologia Medica ( Site 1135)
Milan
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)
Napoli
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136)
Rome
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1138)
Rozzano
Japan
National Cancer Center Hospital East ( Site 1321)
Kashiwa
Aichi Cancer Center Hospital ( Site 1324)
Nagoya
Osaka International Cancer Institute ( Site 1323)
Osaka
National Cancer Center Hospital ( Site 1322)
Tokyo
Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1121)
Amsterdam
Erasmus Medisch Centrum-Medical Oncology ( Site 1122)
Rotterdam
Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)
Gdansk
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)
Koszalin
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101
Warsaw
Republic of Korea
Asan Medical Center ( Site 1313)
Seoul
Seoul National University Hospital-Internal Medicine ( Site 1312)
Seoul
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)
Seoul
Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)
Hospitalet
Clinica Universidad de Navarra-Medical Oncology ( Site 1118)
Madrid
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)
Madrid
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)
Pozuelo De Alarcón
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)
Seville
Taiwan
NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)
Tainan
Mackay Memorial Hospital ( Site 1305)
Taipei
National Taiwan University Hospital-Oncology ( Site 1301)
Taipei
Chang Gung Medical Foundation-Linkou Branch ( Site 1304)
Taoyuan District
Turkey
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)
Adana
Ankara City Hospital-Medical Oncology ( Site 1202)
Ankara
Hacettepe Universitesi-oncology hospital ( Site 1209)
Ankara
Trakya University-Medical Oncology ( Site 1207)
Edirne
Acibadem Universitesi Atakent Hastanesi ( Site 1208)
Istanbul
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)
Istanbul
Istanbul Universitesi Cerrahpasa ( Site 1203)
Istanbul- Fatih
Time Frame
Start Date: 2021-09-16
Completion Date: 2025-08-05
Participants
Target number of participants: 613
Treatments
Experimental: 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.
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC