RecruitingPhase 3NCT07405164

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

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

450 participants

Start Date

Mar 23, 2026

Study Type

INTERVENTIONAL

Conditions

Carcinoma, Renal Cell Von Hippel-Lindau Disease

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term extension study for people who were previously enrolled in a clinical trial involving belzutifan (also known as MK-6482) — a drug used for certain cancers including kidney cancer and tumors related to a genetic condition called Von Hippel-Lindau disease. The study allows participants to continue receiving treatment and be monitored for long-term safety. **You may be eligible if...** - You have advanced solid tumors or Von Hippel-Lindau-related tumors - You are currently on active treatment with belzutifan in a parent clinical study **You may NOT be eligible if...** - You are currently experiencing a serious side effect from the parent study that has not resolved - Your treatment is currently paused due to a side effect (though you may become eligible once treatment resumes) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBelzutifan

Belzutifan is administered orally at 120 mg once daily (qd) OR 160 mg twice daily (bid) OR 160 mg three times daily (tid) OR 200 mg qd OR 240 mg qd until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

DRUGPalbociclib

Palbociclib is administered orally at 75 mg qd OR 100 mg qd OR 125 mg qd for 21 consecutive days; 7 days off, until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

DRUGNivolumab

Nivolumab is administered intravenously at 480 mg until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

DRUGLenvatinib

Lenvatinib is administered orally at 20 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

DRUGCabozantinib

Cabozantinib is administered orally at 60 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

DRUGEverolimus

Everolimus is administered orally at 10 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.