Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT07405164
This extension study evaluates the long-term effects of belzutifan in participants with advanced solid tumors or VHL-related neoplasms from prior belzutifan trials. Eligible participants continue treatment with belzutifan and may receive additional drugs like palbociclib, nivolumab, lenvatinib, cabozantinib, or everolimus, depending on their condition and previous study involvement.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Karmanos Cancer Center ( Site 0108) | 48201 | Detroit | Michigan |
| START San Antonio ( Site 0104) | 78229 | San Antonio | Texas |
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