NCT07405164 Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
| NCT ID | NCT07405164 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Von Hippel-Lindau Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2026-03-23 |
| Primary Completion | 2034-01-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 450 participants in total. It began in 2026-03-23 with a primary completion date of 2034-01-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Researchers are looking for new ways to treat advanced solid tumors and von Hippel-Lindau (VHL)-related tumors: * Advanced means the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery * Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids * VHL-related tumors are tumors caused by VHL disease. VHL disease is passed down from parents to children and people with VHL disease have a higher chance of getting certain types of cancer Researchers want to learn about the long-term effects of a trial medicine called belzutifan. Belzutifan, also called MK-6482, is designed to block a protein that helps tumors grow and survive. This is an extension trial, which means only people who were in certain other belzutifan trials (called parent trials) may be able to join. The goal of this trial is to learn how long people live after they start taking belzutifan.
Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * 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: The main exclusion criteria include but are not limited to the following: * 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.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT07405164 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Von Hippel-Lindau Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07405164 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 450 participants.
Is NCT07405164 currently recruiting?
Yes, NCT07405164 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT07405164 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States, Detroit, United States, Philadelphia, United States and 11 additional locations.
Who is sponsoring the NCT07405164 clinical trial?
NCT07405164 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 450 participants.