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

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 200 mg qd until progressive disease (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.


Locations(48)

Beth Israel Deaconess Medical Center ( Site 0107)

Boston, Massachusetts, United States

Dana-Farber Cancer Institute ( Site 0105)

Boston, Massachusetts, United States

Karmanos Cancer Center ( Site 0108)

Detroit, Michigan, United States

Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 0100)

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee, United States

START San Antonio ( Site 0104)

San Antonio, Texas, United States

Fred Hutchinson Cancer Center ( Site 0106)

Seattle, Washington, United States

St George Hospital-Oncology Clinical Research Unit ( Site 2701)

Kogarah, New South Wales, Australia

Westmead Hospital ( Site 2703)

Sydney, New South Wales, Australia

UZ Leuven ( Site 0900)

Leuven, Vlaams-Brabant, Belgium

BP - A Beneficencia Portuguesa de São Paulo ( Site 0200)

São Paulo, São Paulo, Brazil

James Lind Centro de Investigacion del Cancer ( Site 0304)

Temuco, Araucania, Chile

CIDO SpA ( Site 0305)

Temuco, Araucania, Chile

FALP ( Site 0300)

Santiago, Region M. de Santiago, Chile

Oncovida ( Site 0303)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0301)

Santiago, Region M. de Santiago, Chile

ONCOCENTRO APYS ( Site 0302)

Viña del Mar, Valparaiso, Chile

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1000)

Olomouc, Czechia

Herlev and Gentofte Hospital ( Site 1200)

Herlev, Capital Region, Denmark

Tampereen yliopistollinen sairaala ( Site 1305)

Tampere, Pirkanmaa, Finland

Hôpitaux Universitaires de Strasbourg ( Site 1702)

Strasbourg, Bas-Rhin, France

Institut Claudius Regaud ( Site 1703)

Toulouse, Haute-Garonne, France

Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1501)

Budapest, Hungary

Rambam Health Care Campus ( Site 1600)

Haifa, Israel

Hadassah Medical Center ( Site 1604)

Jerusalem, Israel

Rabin Medical Center ( Site 1602)

Petah Tikva, Israel

Sheba Medical center ( Site 1601)

Ramat Gan, Israel

Sourasky Medical Center ( Site 1603)

Tel Aviv, Israel

Kyushu University Hospital ( Site 3101)

Fukuoka, Japan

Maastricht Universitair Medisch Centrum - MUMC ( Site 1900)

Maastricht, Limburg, Netherlands

Isala, locatie Zwolle ( Site 1902)

Zwolle, Overijssel, Netherlands

Auckland City Hospital ( Site 3000)

Auckland, New Zealand

Zakład Diagnostyki Laboratoryjnej, Centrum Onkologii ( Site 2000)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

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 Universitari Vall d'Hebron ( Site 2300)

Barcelona, Spain

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

The Beatson West of Scotland Cancer Centre ( Site 2505)

Glasgow, Glasgow City, United Kingdom

St Bartholomew's Hospital ( Site 2500)

London, London, City of, United Kingdom

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2502)

London, London, City of, United Kingdom

Imperial College Healthcare NHS Trust, Charing Cross Hospital ( Site 2504)

London, London, City of, United Kingdom

The Christie NHS Foundation Trust ( Site 2501)

Manchester, United Kingdom

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