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Belzutifan extension trial aims to extend lives in VHL and advanced cancer

NCT ID NCT07405164

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 15 times

Summary

This extension study follows people with von Hippel-Lindau (VHL) disease or advanced solid tumors who are already taking belzutifan in another trial. The goal is to see how long they live and how safe the drug is over the long term. About 450 participants will take belzutifan by mouth daily until their disease gets worse or side effects become too severe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Belzutifan (a drug that blocks a protein helping tumors grow)
What this could lead to
If successful, this trial could show that belzutifan helps people with VHL disease or advanced solid tumors live longer while managing their cancer over time.
What could go wrong
This is an extension study, so it only includes people already on belzutifan. It is not testing a new treatment, and results may not apply to everyone. Side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jan 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

cancer neoplasm renal cell adenocarcinoma renal cell carcinoma von Hippel-Lindau disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, renal cell Malignant neoplasms Von Hippel-Lindau disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    47 sites in 18 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center ( Site 2900)

    RECRUITING

    Seoul, 05505, South Korea

  • Auckland City Hospital ( Site 3000)

    RECRUITING

    Auckland, 1023, New Zealand

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

    ACTIVE_NOT_RECRUITING

    São Paulo, São Paulo, 01323-001, Brazil

  • Beth Israel Deaconess Medical Center ( Site 0107)

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Bradfordhill ( Site 0301)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • CIDO SpA ( Site 0305)

    RECRUITING

    Temuco, Araucania, 4810148, Chile

  • CNCE Precarpathian Clinical Oncologic Center ( Site 2600)

    ACTIVE_NOT_RECRUITING

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

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

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

  • Dana-Farber Cancer Institute ( Site 0105)

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • FALP ( Site 0300)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1000)

    RECRUITING

    Olomouc, 77900, Czechia

  • Frankston Hospital-Oncology and Haematology ( Site 2705)

    RECRUITING

    Frankston, Victoria, 3199, Australia

  • Fred Hutchinson Cancer Center ( Site 0106)

    RECRUITING

    Seattle, Washington, 98109, United States

  • Gustave Roussy ( Site 1701)

    RECRUITING

    Villejuif, Val-de-Marne, 94805, France

  • Hadassah Medical Center ( Site 1604)

    RECRUITING

    Jerusalem, 9112001, Israel

  • Herlev and Gentofte Hospital ( Site 1200)

    RECRUITING

    Herlev, Capital Region, 2370, Denmark

  • Hospital Universitari Vall d'Hebron ( Site 2300)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre ( Site 2301)

    RECRUITING

    Madrid, 28041, Spain

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

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Hôpitaux Universitaires de Strasbourg ( Site 1702)

    RECRUITING

    Strasbourg, Bas-Rhin, 67200, France

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

    ACTIVE_NOT_RECRUITING

    London, London, City of, W6 8RF, United Kingdom

  • Institut Claudius Regaud ( Site 1703)

    RECRUITING

    Toulouse, Haute-Garonne, 31059, France

  • Isala, locatie Zwolle ( Site 1902)

    RECRUITING

    Zwolle, Overijssel, 8025 AB, Netherlands

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

    RECRUITING

    Temuco, Araucania, 4800827, Chile

  • Jewish General Hospital ( Site 0001)

    ACTIVE_NOT_RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Karmanos Cancer Center ( Site 0108)

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Kyushu University Hospital ( Site 3101)

    RECRUITING

    Fukuoka, 812-8582, Japan

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

    RECRUITING

    Dnipropetrovsk, Dnipropetrovsk Oblast, 49005, Ukraine

  • Maastricht Universitair Medisch Centrum - MUMC ( Site 1900)

    RECRUITING

    Maastricht, Limburg, 6229 HX, Netherlands

  • N.N. Blokhin NMRCO ( Site 2101)

    ACTIVE_NOT_RECRUITING

    Moscow, Moscow, 115478, Russia

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

    RECRUITING

    Amsterdam, North Holland, 1066 CX, Netherlands

  • ONCOCENTRO APYS ( Site 0302)

    RECRUITING

    Viña del Mar, Valparaiso, 2520598, Chile

  • Oncovida ( Site 0303)

    RECRUITING

    Santiago, Region M. de Santiago, 7500994, Chile

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

    RECRUITING

    Budapest, 1122, Hungary

  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2502)

    RECRUITING

    London, London, City of, SW3 6JJ, United Kingdom

  • Rabin Medical Center ( Site 1602)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus ( Site 1600)

    RECRUITING

    Haifa, 3109601, Israel

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

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • SCRI Oncology Partners ( Site 7000)

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START San Antonio ( Site 0104)

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Samsung Medical Center ( Site 2902)

    RECRUITING

    Gangnam, Seoul, 06351, South Korea

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

    RECRUITING

    Seodaemun-gu, Seoul, 03722, South Korea

  • Sheba Medical center ( Site 1601)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Sourasky Medical Center ( Site 1603)

    RECRUITING

    Tel Aviv, 64239, Israel

  • St Bartholomew's Hospital ( Site 2500)

    RECRUITING

    London, London, City of, EC1A 7BE, United Kingdom

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

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • Taipei Veterans General Hospital ( Site 2800)

    ACTIVE_NOT_RECRUITING

    Taipei, 11217, Taiwan

  • Tampereen yliopistollinen sairaala ( Site 1305)

    RECRUITING

    Tampere, Pirkanmaa, 33520, Finland

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

    RECRUITING

    Glasgow, Glasgow City, G12 0YN, United Kingdom

  • The Christie NHS Foundation Trust ( Site 2501)

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • Tokushima University Hospital ( Site 3102)

    RECRUITING

    Tokushima, 770-8503, Japan

  • Toranomon Hospital ( Site 3100)

    RECRUITING

    Minato, Tokyo, 105-8470, Japan

  • UZ Leuven ( Site 0900)

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Westmead Hospital ( Site 2703)

    RECRUITING

    Sydney, New South Wales, 2145, Australia

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