Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)
NCT ID: NCT04976634
Last Updated: 2025-04-06
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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ACTIVE_NOT_RECRUITING
PHASE2
730 participants
INTERVENTIONAL
2021-08-18
2027-03-22
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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Arm 1: Pembrolizumab + Belzutifan + Lenvatinib
Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg (For HCC: 8 mg \[body weight \<60kg\] or 12 mg \[body weight ≥ 60 kg\]). Pembrolizumab will be administered via intravenous (IV) infusion once every 6 weeks (Q6W) for a maximum of 18 doses (approximately 2 years). Belzutifan and lenvatinib will be administered orally once daily (QD) until progressive disease or discontinuation.
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
Arm 2: Pembrolizumab + Lenvatinib
Participants with IO resistant ESCC will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered via intravenous (IV) infusion once every 6 weeks (Q6W) for a maximum of 18 doses (approximately 2 years). Lenvatinib will be administered orally once daily (QD) until progressive disease or discontinuation.
Pembrolizumab
Pembrolizumab 400 mg administered Q6W via IV infusion
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hepatocellular carcinoma (HCC)
* Colorectal cancer (CRC) (non-microsatellite instability-high \[non-MSI-H\]/deficient mismatch repair \[dMMR\])
* Pancreatic ductal adenocarcinoma (PDAC).
* Biliary tract cancer (BTC) (includes intrahepatic, extrahepatic cholangiocarcinoma \[CCA\] and gall bladder cancer)
* Endometrial cancer (EC)
* Esophageal squamous cell carcinoma (ESCC)
* Disease progression on or since the most recent treatment (does not apply to newly diagnosed unresectable or metastatic HCC or EC).
* Measurable disease per RECIST v1.1 as assessed locally (by investigator) and verified by BICR
* Submission of an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Male participants are abstinent from heterosexual intercourse or agree to follow contraceptive guidance during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib
* 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 during the intervention period and and for at least 120 days after the last dose of pembrolizumab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
* Adequate organ function
* Adequately controlled blood pressure with or without antihypertensive medications
Exclusion Criteria
* History of a second malignancy that is progressing or has required active treatment within 3 years
* A pulse oximeter reading \<92% at rest, or requirement of intermittent supplemental oxygen/ chronic supplemental oxygen
* Presence of central nervous system (CNS) metastases and/or carcinomatous meningitis
* Clinically significant cardiovascular disease within 6 months of first dose of study intervention
* Symptomatic pleural effusion, unless clinically stable after treatment
* Preexisting ≥ Grade 3 gastrointestinal (GI) or non-GI fistula
* Moderate to severe hepatic impairment
* Clinically significant history of bleeding within 3 months before screening
* Presence of serious active nonhealing wound/ulcer/bone fracture
* Requirement for hemodialysis or peritoneal dialysis
* History of human immunodeficiency virus (HIV) infection
* History of Hepatitis B or active Hepatis C virus infections. with exceptions for HCC and BTC
* Prior therapy with a PD-1, anti-PD-L1, anti-PD-L2 agent, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) or hypoxia-inducible factor 2α (HIF-2α)
* Radiographic evidence of intratumoral cavitation, or invasion/infiltration of a major blood vessel
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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University of Arizona Cancer Center-University of Arizona Cancer Center - North Campus ( Site 5047)
Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center ( Site 5002)
Duarte, California, United States
Cedars-Sinai Medical Center ( Site 5045)
Los Angeles, California, United States
UCSF Medical Center at Mission Bay ( Site 5021)
San Francisco, California, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 5013)
New Haven, Connecticut, United States
Sibley Memorial Hospital ( Site 5051)
Washington D.C., District of Columbia, United States
University of Florida College of Medicine ( Site 5015)
Gainesville, Florida, United States
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 5048)
Baltimore, Maryland, United States
Brigitte Harris Cancer Pavilion ( Site 5055)
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center ( Site 5050)
New York, New York, United States
Duke Cancer Institute ( Site 5026)
Durham, North Carolina, United States
University of Texas MD Anderson Cancer Center-Gastrointestinal Medical Oncology ( Site 5049)
Houston, Texas, United States
Inova Schar Cancer Institute ( Site 5039)
Fairfax, Virginia, United States
Blue Ridge Cancer Care ( Site 5053)
Roanoke, Virginia, United States
Northwest Medical Specialties, PLLC ( Site 5025)
Tacoma, Washington, United States
University of Wisconsin Hospitals and Clinics ( Site 5037)
Madison, Wisconsin, United States
Gosford Hospital-Oncology Trials ( Site 4004)
Gosford, New South Wales, Australia
Westmead Hospital-Department of Medical Oncology ( Site 4001)
Westmead, New South Wales, Australia
Northern Hospital-Department of Medical Oncology ( Site 4003)
Epping, Victoria, Australia
Cabrini Hospital - Malvern-Cabrini Institute ( Site 4000)
Malvern, Victoria, Australia
Antwerp University Hospital-Oncology ( Site 1002)
Edegem, Antwerpen, Belgium
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001)
Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Leuven ( Site 1000)
Leuven, Vlaams-Brabant, Belgium
AZ Delta vzw ( Site 1004)
Roeselare, West-Vlaanderen, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1003)
Namur, , Belgium
Clínica Puerto Montt ( Site 3110)
Port Montt, Los Lagos Region, Chile
FALP-UIDO ( Site 3102)
Santiago, Region M. de Santiago, Chile
Oncovida ( Site 3108)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 3100)
Santiago, Region M. de Santiago, Chile
Centro Investigación del Cáncer James Lind ( Site 3107)
Temuco, Región de la Araucanía, Chile
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1103)
Rennes, Brittany Region, France
CHU Besançon-Medical oncology ( Site 1101)
Besançon, Doubs, France
CHU Brest Cavale Blanche ( Site 1107)
Brest, Finistere, France
Institut Regional du Cancer Montpellier ( Site 1106)
Montpellier, Herault, France
Centre Hospitalier Universitaire de Grenoble-Medical Oncology ( Site 1105)
La Tronche, Isere, France
Sainte Catherine Institut du Cancer Avignon Provence ( Site 1108)
Avignon, Vaucluse, France
Hôpital Beaujon-Oncologie Digestive ( Site 1104)
Clichy, Île-de-France Region, France
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
Sourasky Medical Center-Oncology ( Site 1301)
Tel Aviv, , Israel
Maastricht UMC+-Medical Oncology ( Site 1501)
Maastricht, Limburg, Netherlands
Leids Universitair Medisch Centrum-Medical Oncology ( Site 1504)
Leiden, South Holland, Netherlands
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1503)
Utrecht, , Netherlands
Auckland City Hospital-Liver Research Unit ( Site 4201)
Grafton, Auckland, New Zealand
Auckland City Hospital-Cancer & Blood Research ( Site 4200)
Auckland, , New Zealand
Chonnam National University Hwasun Hospital-Hemato-Oncology ( Site 4105)
Hwasun Gun, Jeonranamdo, South Korea
Keimyung University Dongsan Hospital CRC room 1 ( Site 4104)
Daegu, Taegu-Kwangyokshi, South Korea
Seoul National University Hospital-Internal Medicine ( Site 4103)
Seoul, , South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 4100)
Seoul, , South Korea
Asan Medical Center-Department of Oncology ( Site 4101)
Seoul, , South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 4102)
Seoul, , South Korea
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1806)
Badalona, Barcelona, Spain
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 1807)
Santiago de Compostela, La Coruna, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1801)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1802)
Oviedo, Principality of Asturias, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 1800)
Barcelona, , Spain
Countries
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References
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Gebrael G, Sahu KK, Agarwal N, Maughan BL. Update on combined immunotherapy for the treatment of advanced renal cell carcinoma. Hum Vaccin Immunother. 2023 Dec 31;19(1):2193528. doi: 10.1080/21645515.2023.2193528. Epub 2023 Apr 16.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-6482-016
Identifier Type: OTHER
Identifier Source: secondary_id
2023-503905-12-00
Identifier Type: CTIS
Identifier Source: secondary_id
U1111-1288-3020
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-005007-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
6482-016
Identifier Type: -
Identifier Source: org_study_id
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