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Clinical Trials/2025-524160-38-00
2025-524160-38-00
Recruiting
Phase 3

A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long‑term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)

Merck Sharp & Dohme LLC13 sites in 8 countries19 target enrollmentStarted: May 1, 2026Last updated:
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ConditionsRenal Cell Carcinoma, hepatocellular carcinoma, nonMSI-H/dMMR colorectal cancer, pancreatic ductal adenocarcinoma, biliary tract cancer, non-MSIH/dMMR endometrial cancer, esophageal squamous cell carcinoma, Advanced Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, von Hippel-Lindau (VHL)Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor, Advanced Solid Tumors With HIF-2α related Genetic Alterations
InterventionsBelzutifanLenvatinib
DrugsBelzutifanLenvatinib, LenvatinibLenvatinib

Overview

Phase
Phase 3
Status
Recruiting
Enrollment
19
Locations
13
Primary Endpoint
Overall survival (OS)
OverviewEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To assess OS in Cohort A and Cohort B

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Participants with advanced solid tumors or von Hippel-Lindau-related neoplasms who are participating in belzutifan-containing studies and on active treatment in a belzutifan parent study

Exclusion Criteria

  • •Has an on-going serious adverse event in the parent study, unless no longer hospitalized and considered clinically stable
  • •Is currently on a dose interruption due to an Adverse Event (AE) in the parent study; once treatment has been resumed in the parent study, the participant is eligible to enroll

Arms & Interventions

Belzutifan

Test

Intervention: Belzutifan (Drug)

Lenvatinib, Lenvatinib

Test

Intervention: Lenvatinib (Drug)

Outcomes

Primary Outcomes

Overall survival (OS)

Overall survival (OS)

Secondary Outcomes

  • Number of Participants Who Experience One or More Adverse Events (AEs)
  • Number of Participants Who Discontinue Study Treatment Due to AEs

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Jelena Todoric

Scientific

Merck Sharp & Dohme LLC

Study Sites (13)

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