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Von Hippel-Lindau DiseasePhase 3NCT07405164

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

A Phase 3 study testing Belzutifan, Nivolumab and Lenvatinib in people with Von Hippel-Lindau Disease and Malignant Neoplasms, run by Merck Sharp & Dohme LLC at 57 sites in 22 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Belzutifan, Nivolumab and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
57 sitesin 22 countries
Study dates
23 Mar 2026to 22 Apr 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

57 sites in 22 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

57 sites in 22 countries

United States8 sites, 8 recruiting

  • Beth Israel Deaconess Medical Center ( Site 0107)

    Boston, Massachusetts, 02215

    Study Coordinator, 617-667-7000

    Recruiting

  • Dana-Farber Cancer Institute ( Site 0105)

    Boston, Massachusetts, 02215

    Study Coordinator, 617-632-3466

    Recruiting

  • Karmanos Cancer Center ( Site 0108)

    Detroit, Michigan, 48201

    Study Coordinator, 800-527-6266

    Recruiting

  • SCRI Oncology Partners ( Site 7000)

    Nashville, Tennessee, 37203

    Study Coordinator, 615-329-7274

    Recruiting

  • Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 0100)

    Philadelphia, Pennsylvania, 19104

    Study Coordinator, 215-360-0737

    Recruiting

  • UPMC Hillman Cancer Center ( Site 0101)

    Pittsburgh, Pennsylvania, 15232

    Study Coordinator, 412-647-2811

    Recruiting

  • START San Antonio ( Site 0104)

    San Antonio, Texas, 78229

    Study Coordinator, 210-593-5265

    Recruiting

  • Fred Hutchinson Cancer Center ( Site 0106)

    Seattle, Washington, 98109

    Study Coordinator, 206-606-7341

    Recruiting

Other trials in United States

Chile6 sites, 6 recruiting

  • Fundación Arturo López Pérez ( Site 0300)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56224457254

    Recruiting

  • Oncovida ( Site 0303)

    Santiago, Region M. de Santiago, 7500994

    Study Coordinator, +56225992900

    Recruiting

  • Bradfordhill ( Site 0301)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56229490970

    Recruiting

  • James Lind Centro de Investigacion del Cancer ( Site 0304)

    Temuco, Araucania, 4800827

    Study Coordinator, +56452316296

    Recruiting

  • CIDO SpA ( Site 0305)

    Temuco, Araucania, 4810148

    Study Coordinator, +56452657374

    Recruiting

  • ONCOCENTRO APYS ( Site 0302)

    Viña del Mar, Valparaiso, 2520598

    Study Coordinator, +56323320861

    Recruiting

Other trials in Chile

Israel5 sites, 5 recruiting

  • Rambam Health Care Campus ( Site 1600)

    Haifa, 3109601

    Study Coordinator, +97247772688

    Recruiting

  • Hadassah Medical Center ( Site 1604)

    Jerusalem, 9112001

    Study Coordinator, +97226777333

    Recruiting

  • Rabin Medical Center ( Site 1602)

    Petah Tikva, 4941492

    Study Coordinator, +97239377377

    Recruiting

  • Sheba Medical center ( Site 1601)

    Ramat Gan, 5265601

    Study Coordinator, +972035303030

    Recruiting

  • Sourasky Medical Center ( Site 1603)

    Tel Aviv, 64239

    Study Coordinator, + 972 3 6947284

    Recruiting

Other trials in Israel

United Kingdom5 sites, 4 recruiting

  • The Beatson West of Scotland Cancer Centre ( Site 2505)

    Glasgow, Glasgow City, G12 0YN

    Study Coordinator, +441413017064

    Recruiting

  • St Bartholomew's Hospital ( Site 2500)

    London, London, City of, EC1A 7BE

    Study Coordinator, +442072533411

    Recruiting

  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2502)

    London, London, City of, SW3 6JJ

    Study Coordinator, +442087523829

    Recruiting

  • Imperial College Healthcare NHS Trust, Charing Cross Hospital ( Site 2504)

    London, London, City of, W6 8RF

    Active, not recruiting

  • The Christie NHS Foundation Trust ( Site 2501)

    Manchester, M20 4BX

    Study Coordinator, 0161 918 7884

    Recruiting

Other trials in United Kingdom

Australia4 sites, 4 recruiting

  • Frankston Hospital-Oncology and Haematology ( Site 2705)

    Frankston, Victoria, 3199

    Study Coordinator, +610397847175

    Recruiting

  • St George Hospital-Oncology Clinical Research Unit ( Site 2701)

    Kogarah, New South Wales, 2217

    Study Coordinator, +6191133830

    Recruiting

  • One Clinical Research ( Site 2704)

    Nedlands, Western Australia, 6009

    Study Coordinator, +6186279 9466

    Recruiting

  • Westmead Hospital ( Site 2703)

    Sydney, New South Wales, 2145

    Study Coordinator, +61288908383

    Recruiting

Other trials in Australia

France3 sites, 3 recruiting

  • Hôpitaux Universitaires de Strasbourg ( Site 1702)

    Strasbourg, Bas-Rhin, 67200

    Study Coordinator, +33368766767

    Recruiting

  • Institut Claudius Regaud ( Site 1703)

    Toulouse, Haute-Garonne, 31059

    Study Coordinator, +33531155050

    Recruiting

  • Gustave Roussy ( Site 1701)

    Villejuif, Val-de-Marne, 94805

    Study Coordinator, 0033142114211

    Recruiting

Other trials in France

Japan3 sites, 3 recruiting

  • Kyushu University Hospital ( Site 3101)

    Fukuoka, 812-8582

    Study Coordinator, +81-92-641-1151

    Recruiting

  • Toranomon Hospital ( Site 3100)

    Minato, Tokyo, 105-8470

    Study Coordinator, +81-3-3588-1111

    Recruiting

  • Tokushima University Hospital ( Site 3102)

    Tokushima, 770-8503

    Study Coordinator, +81-88-631-3111

    Recruiting

Other trials in Japan

Netherlands3 sites, 3 recruiting

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1901)

    Amsterdam, North Holland, 1066 CX

    Study Coordinator, +31205129111

    Recruiting

  • Maastricht Universitair Medisch Centrum - MUMC ( Site 1900)

    Maastricht, Limburg, 6229 HX

    Study Coordinator, +31433876400

    Recruiting

  • Isala, locatie Zwolle ( Site 1902)

    Zwolle, Overijssel, 8025 AB

    Study Coordinator, +31886246040

    Recruiting

Other trials in Netherlands

South Korea3 sites, 3 recruiting

  • Samsung Medical Center ( Site 2902)

    Gangnam, Seoul, 06351

    Study Coordinator, +82-2-3410-1767

    Recruiting

  • Severance Hospital, Yonsei University Health System ( Site 2901)

    Seodaemun-gu, Seoul, 03722

    Study Coordinator, +82-2-2228-8138

    Recruiting

  • Asan Medical Center ( Site 2900)

    Seoul, 05505

    Study Coordinator, +82-2-3010-5977

    Recruiting

Other trials in South Korea

Poland2 sites, 2 recruiting

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2000)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

    Study Coordinator, +48523743862

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2002)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48 22 546 23 31

    Recruiting

Other trials in Poland

Russia2 sites

  • N.N. Blokhin NMRCO ( Site 2101)

    Moscow, Moscow, 115478

    Active, not recruiting

  • Russian Scientific Center of Radiology and Surgical Technologies ( Site 2100)

    Saint Petersburg, Sankt-Peterburg, 197758

    Active, not recruiting

Other trials in Russia

Spain2 sites, 2 recruiting

  • Hospital Universitari Vall d'Hebron ( Site 2300)

    Barcelona, 08035

    Study Coordinator, +34934894350

    Recruiting

  • Hospital Universitario 12 de Octubre ( Site 2301)

    Madrid, 28041

    Study Coordinator, +34 91 390 83 39

    Recruiting

Other trials in Spain

Ukraine2 sites, 1 recruiting

  • ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2601)

    Dnipropetrovsk, Dnipropetrovsk Oblast, 49005

    Study Coordinator, +380505896241

    Recruiting

  • CNCE Precarpathian Clinical Oncologic Center ( Site 2600)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

    Active, not recruiting

Other trials in Ukraine

Belgium1 site, 1 recruiting

  • UZ Leuven ( Site 0900)

    Leuven, Vlaams-Brabant, 3000

    Study Coordinator, +32 (0)16 34 69 12

    Recruiting

Other trials in Belgium

Brazil1 site

  • BP - A Beneficencia Portuguesa de São Paulo ( Site 0200)

    São Paulo, São Paulo, 01323-001

    Active, not recruiting

Other trials in Brazil

Canada1 site

  • Jewish General Hospital ( Site 0001)

    Montreal, Quebec, H3T 1E2

    Active, not recruiting

Other trials in Canada

Czechia1 site, 1 recruiting

  • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1000)

    Olomouc, 77900

    Study Coordinator, 588441111

    Recruiting

Other trials in Czechia

Denmark1 site, 1 recruiting

  • Herlev and Gentofte Hospital ( Site 1200)

    Herlev, Capital Region, 2370

    Study Coordinator, +45 38688798

    Recruiting

Other trials in Denmark

Finland1 site, 1 recruiting

  • Tampereen yliopistollinen sairaala ( Site 1305)

    Tampere, Pirkanmaa, 33520

    Study Coordinator, +358331163082

    Recruiting

Other trials in Finland

Hungary1 site, 1 recruiting

  • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1501)

    Budapest, 1122

    Study Coordinator, +3612248600 #3162

    Recruiting

Other trials in Hungary

New Zealand1 site, 1 recruiting

  • Auckland City Hospital ( Site 3000)

    Auckland, 1023

    Study Coordinator, 093074949

    Recruiting

Other trials in New Zealand

Taiwan1 site

  • Taipei Veterans General Hospital ( Site 2800)

    Taipei, 11217

    Active, not recruiting

Other trials in Taiwan

About this study

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)

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.

Being tested
Belzutifan, Nivolumab, Lenvatinib, Cabozantinib
Medical subject headings
von Hippel-Lindau Disease, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelzutifanDrug

    Also called MK-6482, PT2977, WELIREG

    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.

  • NivolumabDrug

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

  • LenvatinibDrug

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

  • CabozantinibDrug

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

Study groups in NCT07405164
Study groupRoleWhat they receive
Cohort A: Belzutifan MonotherapyExperimentalParticipants 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.
Receives: Drug: Belzutifan
Cohort B: Belzutifan Combination TherapyExperimentalParticipants 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.
Receives: Drug: Belzutifan; Drug: Nivolumab; Drug: Lenvatinib; Drug: Cabozantinib
Cohort C: Non-Belzutifan TherapyActive comparatorParticipants 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.
Receives: Drug: Lenvatinib; Drug: Cabozantinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort A and Cohort B: Overall Survival (OS)

    Overall survival is defined as the time from randomization or the first dose of any study intervention in the parent study to death due to any cause.

    Measured: Up to approximately 7 years

Secondary outcomes (2)

  1. Number of Participants Who Experience One or More Adverse Events (AE)

    An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

    Measured: Up to approximately 2 years

  2. Number of Participants Who Discontinued Study Intervention Due to an AE

    An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2026
  2. Study start23 Mar 2026
  3. Primary completion22 Apr 2034 (estimated)
  4. Study completion22 Apr 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07405164
Sponsor's protocol ID
6482-043
Other IDs
U1111-1325-4582, 2025-524160-38-00, MK-6482-043, jRCT2061260008, 2025
Status last verified
Oct 2026
First submitted
5 Feb 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belzutifan, Nivolumab and Lenvatinib in people with Von Hippel-Lindau Disease and Malignant Neoplasms, run by Merck Sharp & Dohme LLC at 57 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Chile, Israel, United Kingdom, Australia and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort A and Cohort B: Overall Survival (OS) (time frame: Up to approximately 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07405164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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