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Recruiting NCT07405164

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

Phase III Interventional Von Hippel-Lindau Disease Malignant Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Belzutifan, Nivolumab, Lenvatinib, Cabozantinib.
Who it may be relevant to
Registry conditions: Von Hippel-Lindau Disease, Malignant Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Belgium, Brazil, Chile +16
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

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.

Interventions

  • Drug 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.
  • Drug Nivolumab
    Nivolumab is administered intravenously at 480 mg until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
  • Drug Lenvatinib
    Lenvatinib is administered orally at 20 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
  • Drug Cabozantinib
    Cabozantinib is administered orally at 60 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

Primary outcome measures

  • Cohort A and Cohort B: Overall Survival (OS) [Time frame: Up to approximately 7 years]
Secondary outcome measures (2)
  • Number of Participants Who Experience One or More Adverse Events (AE) [Time frame: Up to approximately 2 years]
  • Number of Participants Who Discontinued Study Intervention Due to an AE [Time frame: Up to approximately 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Beth Israel Deaconess Medical Center ( Site 0107) — Boston
  • Dana-Farber Cancer Institute ( Site 0105) — Boston
  • Karmanos Cancer Center ( Site 0108) — Detroit
  • Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 01 — Philadelphia
  • SCRI Oncology Partners ( Site 7000) — Nashville
  • START San Antonio ( Site 0104) — San Antonio
  • Fred Hutchinson Cancer Center ( Site 0106) — Seattle
Chile · 6 centers
  • James Lind Centro de Investigacion del Cancer ( Site 0304) — Temuco
  • CIDO SpA ( Site 0305) — Temuco
  • FALP ( Site 0300) — Santiago
  • Oncovida ( Site 0303) — Santiago
  • Bradfordhill ( Site 0301) — Santiago
  • ONCOCENTRO APYS ( Site 0302) — Viña del Mar
Israel · 5 centers
  • Rambam Health Care Campus ( Site 1600) — Haifa
  • Hadassah Medical Center ( Site 1604) — Jerusalem
  • Rabin Medical Center ( Site 1602) — Petah Tikva
  • Sheba Medical center ( Site 1601) — Ramat Gan
  • Sourasky Medical Center ( Site 1603) — Tel Aviv
United Kingdom · 5 centers
  • The Beatson West of Scotland Cancer Centre ( Site 2505) — Glasgow
  • St Bartholomew's Hospital ( Site 2500) — London
  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2502) — London
  • Imperial College Healthcare NHS Trust, Charing Cross Hospital ( Site 2504) — London
  • The Christie NHS Foundation Trust ( Site 2501) — Manchester
South Korea · 3 centers
  • Samsung Medical Center ( Site 2902) — Gangnam
  • Severance Hospital, Yonsei University Health System ( Site 2901) — Seodaemun-gu
  • Asan Medical Center ( Site 2900) — Seoul
Australia · 2 centers
  • St George Hospital-Oncology Clinical Research Unit ( Site 2701) — Kogarah
  • Westmead Hospital ( Site 2703) — Sydney
France · 2 centers
  • Hôpitaux Universitaires de Strasbourg ( Site 1702) — Strasbourg
  • Institut Claudius Regaud ( Site 1703) — Toulouse
Netherlands · 2 centers
  • Maastricht Universitair Medisch Centrum - MUMC ( Site 1900) — Maastricht
  • Isala, locatie Zwolle ( Site 1902) — Zwolle
Russia · 2 centers
  • N.N. Blokhin NMRCO ( Site 2101) — Moscow
  • Russian Scientific Center of Radiology and Surgical Technologies ( Site 2100) — Saint Petersburg
Spain · 2 centers
  • Hospital Universitari Vall d'Hebron ( Site 2300) — Barcelona
  • Hospital Universitario 12 de Octubre ( Site 2301) — Madrid
Ukraine · 2 centers
  • ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2601) — Dnipropetrovsk
  • CNCE Precarpathian Clinical Oncologic Center ( Site 2600) — Ivano-Frankivsk
Belgium · 1 center
  • UZ Leuven ( Site 0900) — Leuven
Brazil · 1 center
  • BP - A Beneficencia Portuguesa de São Paulo ( Site 0200) — São Paulo
Czechia · 1 center
  • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1000) — Olomouc
Denmark · 1 center
  • Herlev and Gentofte Hospital ( Site 1200) — Herlev
Finland · 1 center
  • Tampereen yliopistollinen sairaala ( Site 1305) — Tampere
Hungary · 1 center
  • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site — Budapest
Japan · 1 center
  • Kyushu University Hospital ( Site 3101) — Fukuoka
New Zealand · 1 center
  • Auckland City Hospital ( Site 3000) — Auckland
Poland · 1 center
  • Zakład Diagnostyki Laboratoryjnej, Centrum Onkologii ( Site 2000) — Bydgoszcz
Taiwan · 1 center
  • Taipei Veterans General Hospital ( Site 2800) — Taipei

Identifiers

NCT: NCT07405164 · 6482-043 · U1111-1325-4582 · 2025-524160-38-00 · MK-6482-043 · jRCT2061260008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗