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RECRUITING
NCT07405164
PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2026-03-23

Completion Date

2034-01-14

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

DRUG

Belzutifan

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.

DRUG

Palbociclib

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.

DRUG

Nivolumab

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

DRUG

Lenvatinib

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

DRUG

Cabozantinib

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

DRUG

Everolimus

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

Locations (15)

Karmanos Cancer Center ( Site 0108)

Detroit, Michigan, United States

START San Antonio ( Site 0104)

San Antonio, Texas, United States

UZ Leuven ( Site 0900)

Leuven, Vlaams-Brabant, Belgium

Rambam Health Care Campus ( Site 1600)

Haifa, Israel

Hadassah Medical Center ( Site 1604)

Jerusalem, Israel

Sourasky Medical Center ( Site 1603)

Tel Aviv, Israel

N.N. Blokhin NMRCO ( Site 2101)

Moscow, Moscow, Russia

Russian Scientific Center of Radiology and Surgical Technologies ( Site 2100)

Saint Petersburg, Sankt-Peterburg, Russia

Samsung Medical Center ( Site 2902)

Gangnam, Seoul, South Korea

Severance Hospital, Yonsei University Health System ( Site 2901)

Seodaemun-gu, Seoul, South Korea

Asan Medical Center ( Site 2900)

Seoul, South Korea

Hospital Universitario 12 de Octubre ( Site 2301)

Madrid, Spain

Taipei Veterans General Hospital ( Site 2800)

Taipei, Taiwan

ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2601)

Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine

CNCE Precarpathian Clinical Oncologic Center ( Site 2600)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine