Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab: Pembrolizumab 400 mg administered Q6W via IV infusion
Belzutifan: Belzutifan 120 mg administered QD via oral tablet
Lenvatinib: Lenvantinib dose for HCC is 8 mg QD for body weight \<60 kg and 12 mg QD for body weight ≥ 60 kg administered via oral capsule. For all other tumors, the lenvatinib dose is 20 mg QD administered via oral capsule
Study summary
The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometrial cancer (EC),and esophageal squamous cell carcinoma (ESCC). There is no formal hypothesis testing in this study.
Eligibility
Primary outcome measure(s)
- Arm 1: Number of Participants Who Experience at Least One Dose-limiting Toxicity (DLT) — Up to approximately 21 days
Occurrence of any of the following will be considered a DLT if possibly, probably, or definitely related to study treatment administration: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting \>7 days; Grade 4 thrombocytopenia-any duration; Grade 3 thrombocytopenia if associated with clinically significant hemorrhage; Febrile neutropenia Grade 3 or Grade 4; Grade 3 nonhematologic toxicity lasting \>5 days despite optimal supportive care; Grade 3 hypertension not controlled by antihypertensive medication(s); Grade 3 or Grade 4 nonhematologic laboratory abnormality (if medical intervention is required, or leads to hospitalization, or persists for \>1 week) ; Elevated bilirubin if persists \>4 weeks (for HCC and BTC participants only); Designated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) liver test abnormalities; Treatment-related toxicity resulting in participant discontinuation of study intervention during the DLT window; Grade 5 toxicity. - Arm 1: Number of Participants Who Experience at Least One Adverse Event (AE) — Up to approximately 67 months
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be presented. - Arm 1: Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 67 months
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented separately for the safety lead-in phase (up to 21 days) and the main study. - Confirmed Objective Response Rate (ORR) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) — Up to approximately 67 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Trial sites (57)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arizona Cancer Center-University of Arizona Cancer Center - North Campus ( Site 5047) | Tucson | Arizona | |
| City of Hope Comprehensive Cancer Center ( Site 5002) | Duarte | California | |
| Cedars-Sinai Medical Center ( Site 5045) | Los Angeles | California | |
| UCSF Medical Center at Mission Bay ( Site 5021) | San Francisco | California | |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 5013) | New Haven | Connecticut | |
| Sibley Memorial Hospital ( Site 5051) | Washington D.C. | District of Columbia | |
| University of Florida College of Medicine ( Site 5015) | Gainesville | Florida | |
| Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 5048) | Baltimore | Maryland | |
| Brigitte Harris Cancer Pavilion ( Site 5055) | Detroit | Michigan | |
| Memorial Sloan Kettering Cancer Center ( Site 5050) | New York | New York | |
| Duke Cancer Institute ( Site 5026) | Durham | North Carolina | |
| University of Texas MD Anderson Cancer Center-Gastrointestinal Medical Oncology ( Site 5049) | Houston | Texas | |
| Inova Schar Cancer Institute ( Site 5039) | Fairfax | Virginia | |
| Blue Ridge Cancer Care ( Site 5053) | Roanoke | Virginia | |
| Northwest Medical Specialties, PLLC ( Site 5025) | Tacoma | Washington | |
| University of Wisconsin Hospitals and Clinics ( Site 5037) | Madison | Wisconsin | |
| Gosford Hospital-Oncology Trials ( Site 4004) | Gosford | New South Wales | |
| Westmead Hospital-Department of Medical Oncology ( Site 4001) | Westmead | New South Wales | |
| Northern Hospital-Department of Medical Oncology ( Site 4003) | Epping | Victoria | |
| Cabrini Hospital - Malvern-Cabrini Institute ( Site 4000) | Malvern | Victoria | |
| Antwerp University Hospital-Oncology ( Site 1002) | Edegem | Antwerpen | |
| Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001) | Brussels | Bruxelles-Capitale, Region de | |
| UZ Leuven ( Site 1000) | Leuven | Vlaams-Brabant | |
| AZ Delta vzw ( Site 1004) | Roeselare | West-Vlaanderen | |
| Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1003) | Namur | Belgium | |
| Centro Investigación del Cáncer James Lind ( Site 3107) | Temuco | Araucania | |
| Clínica Puerto Montt ( Site 3110) | Port Montt | Los Lagos Region | |
| FALP-UIDO ( Site 3102) | Santiago | Region M. de Santiago | |
| Oncovida ( Site 3108) | Santiago | Region M. de Santiago | |
| Bradfordhill-Clinical Area ( Site 3100) | Santiago | Region M. de Santiago | |
| Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1103) | Rennes | Brittany Region | |
| CHU Besançon-Medical oncology ( Site 1101) | Besançon | Doubs | |
| CHU Brest Cavale Blanche ( Site 1107) | Brest | Finistere | |
| Institut Regional du Cancer Montpellier ( Site 1106) | Montpellier | Herault | |
| Centre Hospitalier Universitaire de Grenoble-Medical Oncology ( Site 1105) | La Tronche | Isere | |
| Sainte Catherine Institut du Cancer Avignon Provence ( Site 1108) | Avignon | Vaucluse | |
| Hôpital Beaujon-Oncologie Digestive ( Site 1104) | Clichy | Île-de-France Region | |
| Rambam Health Care Campus-Oncology ( Site 1300) | Haifa | Israel | |
| Hadassah Medical Center-Oncology ( Site 1303) | Jerusalem | Israel | |
| Sheba Medical Center-ONCOLOGY ( Site 1302) | Ramat Gan | Israel |
+ 17 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04976634 on ClinicalTrials.gov ↗ ← All trials in South Korea