MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
Uterine Cervical Neoplasms, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck
About this trial
This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Eligibility Criteria
Inclusion Criteria:
One of the following histologically or cytologically confirmed, advanced (locally recurrent 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.
Exclusion Criteria:
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
- 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.
Sites / Locations
- Alaska Womens Cancer Care ( Site 1016)Recruiting
- City of Hope Comprehensive Cancer Center ( Site 1001)Recruiting
- University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
- Karmanos Cancer Institute ( Site 1007)Recruiting
- Memorial Sloan Kettering - Basking Ridge ( Site 1023)Recruiting
- Memorial Sloan Kettering - Monmouth ( Site 1022)Recruiting
- Memorial Sloan Kettering- Commack ( Site 1021)Recruiting
- Memorial Sloan Kettering - Westchester ( Site 1020)Recruiting
- Memorial Sloan Kettering Cancer Center ( Site 1002)Recruiting
- Sanford Cancer Center-Gynecologic Oncology ( Site 1015)Recruiting
- Houston Methodist Hospital ( Site 1017)Recruiting
- Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)Recruiting
- Princess Margaret Cancer Centre ( Site 1056)Recruiting
- James Lind Centro de Investigación del Cáncer ( Site 1404)Recruiting
- FALP-UIDO ( Site 1401)Recruiting
- Oncovida ( Site 1405)Recruiting
- Bradfordhill-Clinical Area ( Site 1402)Recruiting
- Fundación Colombiana de Cancerología Clínica Vida ( Site 1422)Recruiting
- Clinica de la Costa S.A.S. ( Site 1421)Recruiting
- Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)Recruiting
- Oncologos del Occidente ( Site 1424)Recruiting
- Fundación Cardiovascular de Colombia ( Site 1423)Recruiting
- Centre Georges François Leclerc ( Site 1155)Recruiting
- Institut Régional du Cancer Montpellier ( Site 1157)Recruiting
- Gustave Roussy-medicine departement ( Site 1153)Recruiting
- CENTRE LEON BERARD-Medical oncology ( Site 1151)Recruiting
- Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)Recruiting
- Institut Curie ( Site 1152)Recruiting
- Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)Recruiting
- Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, PneRecruiting
- Klinikum der Universität München Großhadern ( Site 1176)Recruiting
- Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)Recruiting
- Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)Recruiting
- Rambam Health Care Campus-Oncology ( Site 1141)Recruiting
- Hadassah Medical Center-Oncology ( Site 1142)Recruiting
- Sheba Medical Center-ONCOLOGY ( Site 1144)Recruiting
- Sourasky Medical Center-Oncology ( Site 1143)Recruiting
- Ospedale San Raffaele-Oncologia Medica ( Site 1135)Recruiting
- Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (Recruiting
- Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)Recruiting
- Aichi Cancer Center Hospital ( Site 1324)Recruiting
- National Cancer Center Hospital East ( Site 1321)Recruiting
- Osaka International Cancer Institute ( Site 1323)Recruiting
- National Cancer Center Hospital ( Site 1322)Recruiting
- Seoul National University Hospital-Internal Medicine ( Site 1312)Recruiting
- Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)Recruiting
- Asan Medical Center ( Site 1313)Recruiting
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1121)Recruiting
- Erasmus Medisch Centrum-Medical Oncology ( Site 1122)Recruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101Recruiting
- Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)Recruiting
- Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)Recruiting
- Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)Recruiting
- Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)Recruiting
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)Recruiting
- Clinica Universidad de Navarra-Medical Oncology ( Site 1118)Recruiting
- HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)Recruiting
- NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)Recruiting
- National Taiwan University Hospital-Oncology ( Site 1301)Recruiting
- Mackay Memorial Hospital ( Site 1305)Recruiting
- Chang Gung Medical Foundation-Linkou Branch ( Site 1304)Recruiting
- Istanbul Universitesi Cerrahpasa ( Site 1203)Recruiting
- Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)Recruiting
- Hacettepe Universitesi-oncology hospital ( Site 1209)Recruiting
- Ankara City Hospital-Medical Oncology ( Site 1202)Recruiting
- Trakya University-Medical Oncology ( Site 1207)Recruiting
- Acibadem Universitesi Atakent Hastanesi ( Site 1208)Recruiting
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Pembrolizumab/Vibostolimab Co-Formulation
Pembrolizumab
Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort)
Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort)
Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin
Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel
Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin
Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab
Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin
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 receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.
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) until meeting discontinuation criteria.
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 until meeting discontinuation criteria.
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 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 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 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 background therapy.
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.