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Recruiting Phase 3 NCT07405164

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

Phase 3 – large-scale trial before approval
Conditions: Von Hippel-Lindau Disease Carcinoma, Renal Cell

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Belzutifan
DRUG
Palbociclib
DRUG
Nivolumab
DRUG
Lenvatinib
DRUG
Cabozantinib
DRUG
Everolimus
DRUG
Locations 9
Israel (1)
Sourasky Medical Center ( Site 1603)
Tel Aviv
Study Coordinator
Russia (1)
Russian Scientific Center of Radiology and Surgical Technologies ( Site 2100)
Saint Petersburg , Sankt-Peterburg
Study Coordinator
South Korea (3)
Samsung Medical Center ( Site 2902)
Gangnam , Seoul
Study Coordinator
Severance Hospital, Yonsei University Health System ( Site 2901)
Seodaemun-gu , Seoul
Study Coordinator
Asan Medical Center ( Site 2900)
Seoul
Study Coordinator
Taiwan (1)
Taipei Veterans General Hospital ( Site 2800)
Taipei
Study Coordinator
Ukraine (2)
ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2601)
Dnipropetrovsk , Dnipropetrovsk Oblast
Study Coordinator
CNCE Precarpathian Clinical Oncologic Center ( Site 2600)
Ivano-Frankivsk , Ivano-Frankivsk Oblast
Study Coordinator
United States (1)
START San Antonio ( Site 0104)
San Antonio , Texas
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
23.03.2026
Completion date
14.01.2034
Registry ID
NCT07405164
Source
clinicaltrials.gov
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