Actively Recruiting
A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Currently on Treatment with Belzutifan
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
450
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new treatments for advanced solid tumors and tumors related to von Hippel-Lindau (VHL) disease, a genetic condition that increases cancer risk. This extension trial focuses on a medicine called belzutifan, which targets a protein that helps tumors grow. The study aims to understand the long-term effects of belzutifan, including how long participants live after starting the treatment. Only people who took part in specific earlier belzutifan studies may join this extension trial. Participants who were receiving belzutifan alone or in combination with other therapies in a previous study will continue their same dose and treatment schedule in this extension. Those who received non-belzutifan treatments are also included and will maintain their prior therapy. Treatment continues until cancer progresses, unacceptable side effects occur, consent is withdrawn, death, investigator decision, or study ends. During the study, participants will be closely monitored with regular visits to track their overall survival and any side effects. Researchers will observe for adverse events and reasons for stopping treatment for up to about 7 years. The study involves evaluations of safety and effectiveness while participants remain on their assigned treatments, with ongoing follow-up to understand long-term outcomes.
CONDITIONS
Brief Title
Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have advanced solid tumors or von Hippel-Lindau-related tumors
- Participants must be currently on active treatment in a belzutifan parent study
- Participants must be aged 18 years or older
You will not qualify if you...
- Participants with ongoing serious adverse events from the parent study unless clinically stable and no longer hospitalized
- Participants currently on dose interruption due to adverse events in the parent study until treatment is resumed in that study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Until progressive disease, unacceptable toxicity, withdrawal, death, investigator decision, or study termination
Participants continue their assigned drug treatment from the parent study, taking medications such as Belzutifan, Palbociclib, Nivolumab, Lenvatinib, Cabozantinib, or Everolimus. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Visits occur as per protocol during ongoing treatment
Trial Site Locations
Total: 20 locations
1
Beth Israel Deaconess Medical Center ( Site 0107)
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Karmanos Cancer Center ( Site 0108)
Detroit, Michigan, United States, 48201
Actively Recruiting
3
START San Antonio ( Site 0104)
San Antonio, Texas, United States, 78229
Actively Recruiting
4
UZ Leuven ( Site 0900)
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
5
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1000)
Olomouc, Czechia, 77900
Actively Recruiting
6
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1501)
Budapest, Hungary, 1122
Actively Recruiting
7
Rambam Health Care Campus ( Site 1600)
Haifa, Israel, 3109601
Actively Recruiting
8
Hadassah Medical Center ( Site 1604)
Jerusalem, Israel, 9112001
Actively Recruiting
9
Rabin Medical Center ( Site 1602)
Petah Tikva, Israel, 4941492
Actively Recruiting
10
Sourasky Medical Center ( Site 1603)
Tel Aviv, Israel, 64239
Actively Recruiting
11
Isala, locatie Zwolle ( Site 1902)
Zwolle, Overijssel, Netherlands, 8025 AB
Actively Recruiting
12
N.N. Blokhin NMRCO ( Site 2101)
Moscow, Moscow, Russia, 115478
Active, Not Recruiting
13
Russian Scientific Center of Radiology and Surgical Technologies ( Site 2100)
Saint Petersburg, Sankt-Peterburg, Russia, 197758
Active, Not Recruiting
14
Samsung Medical Center ( Site 2902)
Gangnam, Seoul, South Korea, 06351
Actively Recruiting
15
Severance Hospital, Yonsei University Health System ( Site 2901)
Seodaemun-gu, Seoul, South Korea, 03722
Actively Recruiting
16
Asan Medical Center ( Site 2900)
Seoul, South Korea, 05505
Actively Recruiting
17
Hospital Universitario 12 de Octubre ( Site 2301)
Madrid, Spain, 28041
Actively Recruiting
18
Taipei Veterans General Hospital ( Site 2800)
Taipei, Taiwan, 11217
Active, Not Recruiting
19
ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2601)
Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine, 49005
Active, Not Recruiting
20
CNCE Precarpathian Clinical Oncologic Center ( Site 2600)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
Active, Not Recruiting
Research Team
T
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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