Extension Study for Belzutifan in Advanced Solid Tumors and VHL-Related Cancers

This study is for people who are already taking belzutifan (MK-6482) in another clinical trial for advanced solid tumors or Von Hippel-Lindau (VHL)-related cancers. Advanced means the cancer has spread or cannot be removed by surgery. VHL-related cancers are tumors caused by VHL disease, a genetic condition. Researchers want to understand the long-term effects of belzutifan, which works by blocking a protein that helps tumors grow. Some participants may also receive nivolumab, lenvatinib, or cabozantinib. The main goal is to see how long people live (Overall Survival) over approximately 7 years. The study plans to enroll about 450 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 450 participants. It is an extension study for those already receiving belzutifan in a parent study.
What's involved
Participants will take belzutifan, nivolumab, lenvatinib, or cabozantinib orally or intravenously until their disease progresses, side effects are too severe, they withdraw, or the study ends.
Compensation
Not stated in the trial record.
Follow-up
Participants' overall survival will be measured for up to approximately 7 years.

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NCT07405164

Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~450 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:BelzutifanNivolumabLenvatinibCabozantinib

At a glance

Recruiting sites
47 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort A and Cohort B: Overall Survival (OS)
Measured over Up to approximately 7 years
Von Hippel-Lindau Disease
Malignant Neoplasms
54 sites across 40 states
Israel5
Region M. de Santiago3
London, City of3
Massachusetts2
New South Wales2
Araucania2
Japan2
Seoul2
  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

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Eligibility criteria

Inclusion

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

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.
  • Cohort A and Cohort B: Overall Survival (OS)Up to approximately 7 years

    Overall survival is defined as the time from randomization or the first dose of any study intervention in the parent study to death due to any cause.