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)
Status: Recruiting
Location: See all (53) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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.
Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center ( Site 0107)
RECRUITING
Boston
Dana-Farber Cancer Institute ( Site 0105)
RECRUITING
Boston
Michigan
Karmanos Cancer Center ( Site 0108)
RECRUITING
Detroit
Pennsylvania
Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 0100)
RECRUITING
Philadelphia
Tennessee
SCRI Oncology Partners ( Site 7000)
RECRUITING
Nashville
Texas
START San Antonio ( Site 0104)
RECRUITING
San Antonio
Washington
Fred Hutchinson Cancer Center ( Site 0106)
RECRUITING
Seattle
Other Locations
Australia
Frankston Hospital-Oncology and Haematology ( Site 2705)
RECRUITING
Frankston
St George Hospital-Oncology Clinical Research Unit ( Site 2701)
RECRUITING
Kogarah
Westmead Hospital ( Site 2703)
RECRUITING
Sydney
Belgium
UZ Leuven ( Site 0900)
RECRUITING
Leuven
Brazil
BP - A Beneficencia Portuguesa de São Paulo ( Site 0200)
ACTIVE_NOT_RECRUITING
São Paulo
Canada
Jewish General Hospital ( Site 0001)
ACTIVE_NOT_RECRUITING
Montreal
Chile
Bradfordhill ( Site 0301)
RECRUITING
Santiago
FALP ( Site 0300)
RECRUITING
Santiago
Oncovida ( Site 0303)
RECRUITING
Santiago
CIDO SpA ( Site 0305)
RECRUITING
Temuco
James Lind Centro de Investigacion del Cancer ( Site 0304)
RECRUITING
Temuco
ONCOCENTRO APYS ( Site 0302)
RECRUITING
Viña Del Mar
Denmark
Herlev and Gentofte Hospital ( Site 1200)
RECRUITING
Herlev
Finland
Tampereen yliopistollinen sairaala ( Site 1305)
RECRUITING
Tampere
France
Hôpitaux Universitaires de Strasbourg ( Site 1702)
RECRUITING
Strasbourg
Institut Claudius Regaud ( Site 1703)
RECRUITING
Toulouse
Gustave Roussy ( Site 1701)
RECRUITING
Villejuif
Hungary
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1501)
RECRUITING
Budapest
Israel
Rambam Health Care Campus ( Site 1600)
RECRUITING
Haifa
Hadassah Medical Center ( Site 1604)
RECRUITING
Jerusalem
Rabin Medical Center ( Site 1602)
RECRUITING
Petah Tikva
Sheba Medical center ( Site 1601)
RECRUITING
Ramat Gan
Sourasky Medical Center ( Site 1603)
RECRUITING
Tel Aviv
Japan
Kyushu University Hospital ( Site 3101)
RECRUITING
Fukuoka
Toranomon Hospital ( Site 3100)
RECRUITING
Minato
Tokushima University Hospital ( Site 3102)
RECRUITING
Tokushima
Netherlands
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1901)
RECRUITING
Amsterdam
Maastricht Universitair Medisch Centrum - MUMC ( Site 1900)
RECRUITING
Maastricht
Isala, locatie Zwolle ( Site 1902)
RECRUITING
Zwolle
New Zealand
Auckland City Hospital ( Site 3000)
RECRUITING
Auckland
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2000)
RECRUITING
Bydgoszcz
Republic of Korea
Samsung Medical Center ( Site 2902)
RECRUITING
Gangnam
Severance Hospital, Yonsei University Health System ( Site 2901)
RECRUITING
Seodaemun-gu
Asan Medical Center ( Site 2900)
RECRUITING
Seoul
Russian Federation
N.N. Blokhin NMRCO ( Site 2101)
ACTIVE_NOT_RECRUITING
Moscow
Russian Scientific Center of Radiology and Surgical Technologies ( Site 2100)
ACTIVE_NOT_RECRUITING
Saint Petersburg
Spain
Hospital Universitari Vall d'Hebron ( Site 2300)
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre ( Site 2301)
RECRUITING
Madrid
Taiwan
Taipei Veterans General Hospital ( Site 2800)
ACTIVE_NOT_RECRUITING
Taipei
Ukraine
ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2601)
RECRUITING
Dnipropetrovsk
CNCE Precarpathian Clinical Oncologic Center ( Site 2600)
ACTIVE_NOT_RECRUITING
Ivano-frankivsk
United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 2505)
RECRUITING
Glasgow
Imperial College Healthcare NHS Trust, Charing Cross Hospital ( Site 2504)
ACTIVE_NOT_RECRUITING
London
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2502)
RECRUITING
London
St Bartholomew's Hospital ( Site 2500)
RECRUITING
London
The Christie NHS Foundation Trust ( Site 2501)
RECRUITING
Manchester
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-03-23
Estimated Completion Date: 2034-01-14
Participants
Target number of participants: 450
Treatments
Experimental: Cohort A: Belzutifan Monotherapy
Participants on active treatment assigned to belzutifan monotherapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Experimental: Cohort B: Belzutifan Combination Therapy
Participants on active treatment assigned to a belzutifan combination therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Active_comparator: Cohort C: Non-Belzutifan Therapy
Participants on active treatment assigned to a non-belzutifan therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC