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Clinical Trials in the UK / NCT07405164
Recruiting Phase 3

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

NCT07405164 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2026-03-23
Last updated
2026-09-03

Condition(s) studied

Von Hippel-Lindau DiseaseMalignant Neoplasms

Investigational drug(s) / intervention(s)

BelzutifanNivolumabLenvatinibCabozantinib

Belzutifan: 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.

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

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
Beth Israel Deaconess Medical Center ( Site 0107) Boston Massachusetts Recruiting
Dana-Farber Cancer Institute ( Site 0105) Boston Massachusetts Recruiting
Karmanos Cancer Center ( Site 0108) Detroit Michigan Recruiting
Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 0100) Philadelphia Pennsylvania Recruiting
SCRI Oncology Partners ( Site 7000) Nashville Tennessee Recruiting
START San Antonio ( Site 0104) San Antonio Texas Recruiting
Fred Hutchinson Cancer Center ( Site 0106) Seattle Washington Recruiting
St George Hospital-Oncology Clinical Research Unit ( Site 2701) Kogarah New South Wales Recruiting
Westmead Hospital ( Site 2703) Sydney New South Wales Recruiting
Frankston Hospital-Oncology and Haematology ( Site 2705) Frankston Victoria Recruiting
UZ Leuven ( Site 0900) Leuven Vlaams-Brabant Recruiting
BP - A Beneficencia Portuguesa de São Paulo ( Site 0200) São Paulo São Paulo Active Not Recruiting
Jewish General Hospital ( Site 0001) Montreal Quebec Active Not Recruiting
James Lind Centro de Investigacion del Cancer ( Site 0304) Temuco Araucania Recruiting
CIDO SpA ( Site 0305) Temuco Araucania Recruiting
FALP ( Site 0300) Santiago Region M. de Santiago Recruiting
Oncovida ( Site 0303) Santiago Region M. de Santiago Recruiting
Bradfordhill ( Site 0301) Santiago Region M. de Santiago Recruiting
ONCOCENTRO APYS ( Site 0302) Viña del Mar Valparaiso Recruiting
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1000) Olomouc Czechia Recruiting
Herlev and Gentofte Hospital ( Site 1200) Herlev Capital Region Recruiting
Tampereen yliopistollinen sairaala ( Site 1305) Tampere Pirkanmaa Recruiting
Hôpitaux Universitaires de Strasbourg ( Site 1702) Strasbourg Bas-Rhin Recruiting
Institut Claudius Regaud ( Site 1703) Toulouse Haute-Garonne Recruiting
Gustave Roussy ( Site 1701) Villejuif Val-de-Marne Recruiting
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1501) Budapest Hungary Recruiting
Rambam Health Care Campus ( Site 1600) Haifa Israel Recruiting
Hadassah Medical Center ( Site 1604) Jerusalem Israel Recruiting
Rabin Medical Center ( Site 1602) Petah Tikva Israel Recruiting
Sheba Medical center ( Site 1601) Ramat Gan Israel Recruiting
Sourasky Medical Center ( Site 1603) Tel Aviv Israel Recruiting
Toranomon Hospital ( Site 3100) Minato Tokyo Recruiting
Kyushu University Hospital ( Site 3101) Fukuoka Japan Recruiting
Tokushima University Hospital ( Site 3102) Tokushima Japan Recruiting
Maastricht Universitair Medisch Centrum - MUMC ( Site 1900) Maastricht Limburg Recruiting
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1901) Amsterdam North Holland Recruiting
Isala, locatie Zwolle ( Site 1902) Zwolle Overijssel Recruiting
Auckland City Hospital ( Site 3000) Auckland New Zealand Recruiting
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2000) Bydgoszcz Kuyavian-Pomeranian Voivodeship Recruiting
N.N. Blokhin NMRCO ( Site 2101) Moscow Moscow Active Not Recruiting

+ 14 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07405164 on ClinicalTrials.gov ↗ ← All trials in the UK