Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)

An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Hepatocellular; Colorectal Neoplasms; Esophageal Neoplasms; Endometrial Neoplasms; Pancreatic Ductal Adenocarcinoma; Biliary Tract Neoplasms
• Intervention / Treatment: Drug: Belzutifan; Drug: Pembrolizumab; Drug: Lenvatinib

• Study Type: Interventional
• Enrollment (Estimated): 730
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Toll Free Number; Phone Number: 1-888-577-8839; Email: Trialsites@merck.com

Study Locations

• Australia
  • New South Wales
    • Gosford, New South Wales, Australia, 2250
      • Recruiting
      • Gosford Hospital-Oncology Trials ( Site 4004)
      • Contact: Study Coordinator; Phone Number: +61243209890
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital-Department of Medical Oncology ( Site 4001)
      • Contact: Study Coordinator; Phone Number: +61288908935
  • Victoria
    • Epping, Victoria, Australia, 3076
      • Recruiting
      • Northern Hospital-Department of Medical Oncology ( Site 4003)
      • Contact: Study Coordinator; Phone Number: 6138405 8303
    • Malvern, Victoria, Australia, 3144
      • Completed
      • Cabrini Hospital - Malvern-Cabrini Institute ( Site 4000)
• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital-Oncology ( Site 1002)
      • Contact: Study Coordinator; Phone Number: +32 3 821 55 80
  • Bruxelles-Capitale, Region De
    • Brussels, Bruxelles-Capitale, Region De, Belgium, 1200
      • Recruiting
      • Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001)
      • Contact: Study Coordinator; Phone Number: +3227641041
  • Namur
    • Yvoir, Namur, Belgium, 5530
      • Recruiting
      • Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1003)
      • Contact: Study Coordinator; Phone Number: 3281423849
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven ( Site 1000)
      • Contact: Study Coordinator; Phone Number: 3216344218
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • Recruiting
      • AZ Delta vzw ( Site 1004)
      • Contact: Study Coordinator; Phone Number: +3251237215
• Chile
  • Araucania
    • Temuco, Araucania, Chile, 4800827
      • Recruiting
      • Centro Investigación del Cáncer James Lind ( Site 3107)
      • Contact: Study Coordinator; Phone Number: +56995579412
  • Los Lagos
    • Puerto Montt, Los Lagos, Chile, 5500243
      • Recruiting
      • Clínica Puerto Montt ( Site 3110)
      • Contact: Study Coordinator; Phone Number: +56998634501
  • Region M. De Santiago
    • Santiago, Region M. De Santiago, Chile, 7510032
      • Recruiting
      • Oncovida ( Site 3108)
      • Contact: Study Coordinator; Phone Number: +56323320850
    • Santiago, Region M. De Santiago, Chile, 8420383
      • Recruiting
      • Bradfordhill-Clinical Area ( Site 3100)
      • Contact: Study Coordinator; Phone Number: +56229490970
    • Santiago, Region M. De Santiago, Chile, 7500921
      • Active, not recruiting
      • FALP-UIDO ( Site 3102)
• France
  • Bretagne
    • Rennes, Bretagne, France, 35042
      • Recruiting
      • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1103)
      • Contact: Study Coordinator; Phone Number: +33299253196
  • Doubs
    • Besançon, Doubs, France, 25000
      • Recruiting
      • CHU Besançon-Medical oncology ( Site 1101)
      • Contact: Study Coordinator; Phone Number: +33370632237
  • Finistere
    • Brest, Finistere, France, 29200
      • Recruiting
      • Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 1107)
      • Contact: Study Coordinator; Phone Number: 33298223428
  • Herault
    • Montpellier, Herault, France, 34298
      • Recruiting
      • Institut Régional du Cancer Montpellier ( Site 1106)
      • Contact: Study Coordinator; Phone Number: 33467612304
  • Ile-de-France
    • Clichy, Ile-de-France, France, 92110
      • Recruiting
      • Hôpital Beaujon-Oncologie Digestive ( Site 1104)
      • Contact: Study Coordinator; Phone Number: +33140875614
  • Isere
    • La Tronche, Isere, France, 38700
      • Recruiting
      • Centre Hospitalier Universitaire de Grenoble-Medical Oncology ( Site 1105)
      • Contact: Study Coordinator; Phone Number: 33476765450
  • Vaucluse
    • Avignon, Vaucluse, France, 84918
      • Recruiting
      • Sainte Catherine Institut du Cancer Avignon Provence ( Site 1108)
      • Contact: Study Coordinator; Phone Number: 33490276268
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus-Oncology ( Site 1300)
    • Contact: Study Coordinator; Phone Number: +97247776700
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Hadassah Medical Center-Oncology ( Site 1303)
    • Contact: Study Coordinator; Phone Number: 97226777957
  • Ramat Gan, Israel, 5265601
    • Recruiting
    • Sheba Medical Center-ONCOLOGY ( Site 1302)
    • Contact: Study Coordinator; Phone Number: 97235307776
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Sourasky Medical Center-Oncology ( Site 1301)
    • Contact: Study Coordinator; Phone Number: 97236973082
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital-Internal Medicine ( Site 4103)
    • Contact: Study Coordinator; Phone Number: 82220723943
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 4100)
    • Contact: Study Coordinator; Phone Number: 82222288050
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center-Department of Oncology ( Site 4101)
    • Contact: Study Coordinator; Phone Number: 82230101720
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center-Division of Hematology/Oncology ( Site 4102)
    • Contact: Study Coordinator; Phone Number: 82234103459
  • Jeonranamdo
    • Hwasun Gun, Jeonranamdo, Korea, Republic of, 58128
      • Recruiting
      • Chonnam National University Hwasun Hospital-Hemato-Oncology ( Site 4105)
      • Contact: Study Coordinator; Phone Number: 82613797633
  • Taegu-Kwangyokshi
    • Daegu, Taegu-Kwangyokshi, Korea, Republic of, 42601
      • Recruiting
      • Keimyung University Dongsan Hospital ( Site 4104)
      • Contact: Study Coordinator; Phone Number: 82532586671
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1503)
    • Contact: Study Coordinator; Phone Number: +31887556308
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Recruiting
      • Maastricht UMC+-Medical Oncology ( Site 1501)
      • Contact: Study Coordinator; Phone Number: +31433872001
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Recruiting
      • Leids Universitair Medisch Centrum-Medical Oncology ( Site 1504)
      • Contact: Study Coordinator; Phone Number: +31715298849
• New Zealand
  • Auckland, New Zealand, 1023
    • Recruiting
    • Auckland City Hospital-Cancer & Blood Research ( Site 4200)
    • Contact: Study Coordinator; Phone Number: +6493670000
  • Auckland
    • Grafton, Auckland, New Zealand, 1023
      • Recruiting
      • Auckland City Hospital-Liver Research Unit ( Site 4201)
      • Contact: Study Coordinator; Phone Number: +6493074949
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron-Oncology ( Site 1800)
    • Contact: Study Coordinator; Phone Number: +34934894158
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Recruiting
      • Hospital Universitario Central de Asturias-Medical Oncology ( Site 1802)
      • Contact: Study Coordinator; Phone Number: +34646662756
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1806)
      • Contact: Study Coordinator; Phone Number: 34934978925
  • La Coruna
    • Santiago de Compostela, La Coruna, Spain, 15706
      • Recruiting
      • CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 1807)
      • Contact: Study Coordinator; Phone Number: 981950511
  • Madrid, Comunidad De
    • Madrid, Madrid, Comunidad De, Spain, 28007
      • Recruiting
      • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1801)
      • Contact: Study Coordinator; Phone Number: +34914269519
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona Cancer Center-University of Arizona Cancer Center - North Campus ( Site 5047)
      • Contact: Study Coordinator; Phone Number: 520-626-8551
  • California
    • Duarte, California, United States, 91010
      • Active, not recruiting
      • City of Hope Comprehensive Cancer Center ( Site 5002)
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center ( Site 5045)
      • Contact: Study Coordinator; Phone Number: 310-423-5776
    • San Francisco, California, United States, 94158
      • Recruiting
      • UCSF Medical Center at Mission Bay ( Site 5021)
      • Contact: Study Coordinator; Phone Number: 415-353-9888
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale-New Haven Hospital-Yale Cancer Center ( Site 5013)
      • Contact: Study Coordinator; Phone Number: 203-737-3472
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Recruiting
      • Sibley Memorial Hospital ( Site 5051)
      • Contact: Study Coordinator; Phone Number: 410-955-6832
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida College of Medicine ( Site 5015)
      • Contact: Study Coordinator; Phone Number: 352-273-7990
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 5048)
      • Contact: Study Coordinator; Phone Number: 410-955-6832
  • New York
    • New York, New York, United States, 10065
      • Completed
      • Memorial Sloan Kettering Cancer Center ( Site 5050)
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Cancer Institute ( Site 5026)
      • Contact: Study Coordinator; Phone Number: 919-684-8111
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center-Gastrointestinal Medical Oncology ( Site 5049)
      • Contact: Study Coordinator; Phone Number: 713-563-4799
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Inova Schar Cancer Institute ( Site 5039)
      • Contact: Study Coordinator; Phone Number: 571-472-4724
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Blue Ridge Cancer Care ( Site 5053)
      • Contact: Study Coordinator; Phone Number: 540-982-0237
  • Washington
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Northwest Medical Specialties, PLLC ( Site 5025)
      • Contact: Study Coordinator; Phone Number: 253-381-0674
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin Hospitals and Clinics ( Site 5037)
      • Contact: Study Coordinator; Phone Number: 608-265-9966

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of one of the following advanced (unresectable and/or metastatic) solid tumors, documented by histopathology or cytopathology:

  • 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
• HCC Specific Inclusion Criteria: No prior systemic chemotherapy, including anti-VEGF therapy, anti-programmed cell-death (PD-1)/PD-L1 or any systemic investigational anticancer agents for advanced/unresectable HCC (1L)
• CRC ([non-MSI-H/dMMR) Specific Inclusion Criteria: Received at least 2 prior lines of systemic therapy for unresectable or metastatic disease which includes fluoropyrimidine, irinotecan and oxaliplatin
• PDAC Specific Inclusion Criteria: Prior therapy with at least 1 (platinum or gemcitabine containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer
• BTC Specific Inclusion Criteria: Received at least 1 prior line of systemic therapy (containing gemcitabine or fluoropyrimidine) for unresectable or metastatic disease
• EC Specific Inclusion Criteria: Study treatment is for 1L therapy of EC and participants should not have received prior systemic chemotherapy. Exception: May have received 1 prior line of line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of a curative-intent resection, if the recurrence occurred ≥6 months after the last dose of chemotherapy or may have received prior radiation with or without chemotherapy
• ESCC Specific Inclusion Criteria: Have experienced radiographic or clinical progression on one prior line of standard systemic therapy (immune oncology (IO) naïve participants) or an anti-PD-1/PD-L1 (IO resistant participants)

Exclusion Criteria:

• Unable to swallow orally administered medication or presence of a gastrointestinal (GI) disorder that may affect study intervention absorption
• 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
• EC specific exclusion criteria: History of carcinosarcoma, endometrial leiomyosarcoma or other high-grade sarcomas, or endometrial stromal sarcomas
• ESCC specific exclusion criteria: Has clinically apparent ascites or pleural effusion or experienced weight loss >20% over approximately 3 months before first dose of study therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Belzutifan; Belzutifan 120 mg administered QD via oral tablet; Other Names: MK-6482; PT2977; WELIREG™; Drug: Pembrolizumab; Pembrolizumab 400 mg administered Q6W via IV infusion; Other Names: MK-3475; KEYTRUDA®; Drug: 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 Names: E7080; MK-7902; LENVIMA®
Experimental: 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.	Drug: Pembrolizumab; Pembrolizumab 400 mg administered Q6W via IV infusion; Other Names: MK-3475; KEYTRUDA®; Drug: 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 Names: E7080; MK-7902; LENVIMA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm 1: Number of Participants Who Experience at Least One Dose-limiting Toxicity (DLT)	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.	Up to approximately 21 days
Arm 1: Number of Participants Who Experience at Least One Adverse Event (AE)	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.	Up to approximately 60 months
Arm 1: Number of Participants Who Discontinue Study Treatment Due to an AE	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.	Up to approximately 59 months
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)	ORR is defined as the percentage of participants who have a Complete Response (CR) or a Partial Response (PR) per RECIST 1.1, as assessed by blinded independent central review (BICR).	Up to approximately 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR	DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first. The DOR per RECIST 1.1 will be assessed by BICR.	Up to approximately 60 months
Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR	DCR is defined as the percentage of participants who have a CR, PR, or Stable Disease (SD). The best overall response of CR, PR, or SD after ≥ 6 weeks will be assessed per RECIST 1.1 by BICR.	Up to approximately 60 months
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR	PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) per RECIST1.1 as assessed by BICR, or death due to any cause, whichever occurs first.	Up to approximately 60 months
Overall Survival (OS)	OS is defined as the time from the first day of study intervention to death due to any cause.	Up to approximately 60 months
ORR Per Modified Response Criteria in Solid Tumors Version 1.1 (mRECIST 1.1) for Hepatocellular Carcinoma (HCC) as Assessed by BICR	ORR is defined as the percentage of participants who have a CR or a PR per mRECIST 1.1 for HCC, as assessed by BICR.	Up to approximately 60 months
DOR Per mRECIST 1.1 for HCC as Assessed by BICR	DOR is defined as the time from the first documented evidence of CR or PR until either progressive disease (PD) or death due to any cause, whichever occurs first. The DOR per mRECISIT 1.1 for HCC willl be assessed by BICR.	Up to approximately 60 months
DCR Per mRECIST 1.1 for HCC as Assessed by BICR	DCR is defined as the percentage of participants who have a CR or PR or SD. The best overall response of CR, PR, or SD after ≥ 6 weeks per mRECIST 1.1 for HCC will be assessed by BICR.	Up to approximately 60 months
PFS Per mRECIST 1.1 for HCC as Assessed by BICR	PFS is defined as the time from first day of study intervention to the first documented PD per mRECIST 1.1 for HCC as assessed by BICR, or death due to any cause, whichever occurs first.	Up to approximately 60 months
Arm 2: Number of Participants Who Experienced an Adverse Event (AE)	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 an AE after administration of pembrolizumab plus lenvatinib will be presented.	Up to approximately 60 months
Arm 2: Number of Participants Who Discontinued Study Treatment Due to an AE	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 of pembrolizumab plus lenvatinib after an AE will be presented.	Up to approximately 59 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): August 18, 2026

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Liver Diseases; Head and Neck Neoplasms; Colonic Diseases; Intestinal Diseases; Liver Neoplasms; Intestinal Neoplasms; Rectal Diseases; Esophageal Diseases; Biliary Tract Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Neoplasms; Carcinoma, Hepatocellular; Colorectal Neoplasms; Endometrial Neoplasms; Esophageal Neoplasms; Biliary Tract Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Immune Checkpoint Inhibitors; Pembrolizumab; Lenvatinib; Belzutifan
• Other Study ID Numbers: 6482-016; MK-6482-016 (Other Identifier: Merck); 2020-005007-40 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No