Clinical trial • Phase III • Oncology
BELZUTIFAN for Renal cell carcinoma|Hepatocellular carcinoma|Colorectal cancer (non‑MSI‑H/dMMR)|Pancreatic ductal adenocarcinoma|Bile duct (biliary tract) cancer|Endometrial cancer (non‑MSI‑H/dMMR)|Esophageal squamous cell carcinoma|Pheochromocytoma/Paraganglioma|Pancreatic neuroendocrine tumor|von Hippel‑Lindau (VHL) disease‑associated tumors|Gastrointestinal stromal tumor|Advanced solid tumors with HIF-2α related genetic alterations
Phase III trial of BELZUTIFAN for Renal cell carcinoma|Hepatocellular carcinoma|Colorectal cancer (non‑MSI‑H/dMMR)|Pancreatic ductal adenocarcinoma|Bile d…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Renal cell carcinoma|Hepatocellular carcinoma|Colorectal cancer (non‑MSI‑H/dMMR)|Pancreatic ductal adenocarcinoma|Bile duct (biliary tract) cancer|Endometrial cancer (non‑MSI‑H/dMMR)|Esophageal squamous cell carcinoma|Pheochromocytoma/Paraganglioma|Pancreatic neuroendocrine tumor|von Hippel‑Lindau (VHL) disease‑associated tumors|Gastrointestinal stromal tumor|Advanced solid tumors with HIF-2α related genetic alterations
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 19-12-2025
- First CTIS Authorization Date
- 28-04-2026
Trial design
open-label Phase III trial across 17 sites in Belgium, Czechia, Denmark and others.
- Open Label
- Yes
- Target Sample Size
- 118
Eligibility
Recruits 118 No vulnerable population selected (isVulnerablePopulationSelected=false); no specific consent/assent handling described.
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false); no specific consent/assent handling described
Inclusion criteria
- {"criterion_text":"-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
- {"criterion_text":"-Has an on-going serious adverse event in the parent study, unless no longer hospitalized and considered clinically stable"}
- {"criterion_text":"-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"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Overall survival (OS)","definition_or_measurement_approach":"To assess OS in Cohort A and Cohort B"}
Secondary endpoints
- {"endpoint_text":"-Number of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants who experience one or more adverse events (AEs)"}
- {"endpoint_text":"-Number of Participants Who Discontinue Study Treatment Due to AEs","definition_or_measurement_approach":"Count of participants who discontinue study treatment due to adverse events (AEs)"}
Recruitment
- Planned Sample Size
- 118
- Recruitment Window Months
- 44
- Consent Approach
- Informed consent obtained from participants using country-specific main consent forms. Main consent documents are provided in country/language-specific versions (examples in the dossier include English, French, Dutch, Spanish, Czech, Danish, German, Hungarian, Polish, Finnish). No assent/guardian consent procedures are described in the available documentation.
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 37
Belgium
- Earliest CTIS Part Ii Submission Date
- 27-03-2026
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 32
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- UZ Leuven
- Department Name
- Medical Oncology
- Contact Person Name
- Benoit Beuselinck
- Contact Person Email
- benoit.beuselinck@uzleuven.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 05-02-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 83
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- University Hospital Olomouc
- Department Name
- Onkologicka klinika
- Contact Person Name
- Bohuslav Melichar
- Contact Person Email
- bohuslav.melichar@fnol.cz
Denmark
- Earliest CTIS Part Ii Submission Date
- 14-04-2026
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Region Hovedstaden
- Department Name
- Deparment of Oncology, KFE
- Contact Person Name
- Anne Kirstine Møller Darras
- Contact Person Email
- anne.kirstine.hundahl.moeller@regionh.dk
France
- Earliest CTIS Part Ii Submission Date
- 20-03-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 45
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Medical Oncology
- Contact Person Name
- Iphigénie Korakis
- Contact Person Email
- Korakis.Iphigenie@iuct-oncopole.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology
- Contact Person Name
- Laurence Albiges
- Contact Person Email
- laurence.albiges@gustaveroussy.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Medical Oncology
- Contact Person Name
- Philippe Barthelemy
- Contact Person Email
- p.bathelemy@icans.eu
Germany
- Earliest CTIS Part Ii Submission Date
- 27-03-2026
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 34
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Universitaetsklinikum Magdeburg AöR
- Department Name
- "Klinik für Urologie, Uro-Onkologie, robotergestützte und fokale Therapie "
- Contact Person Name
- Alexander Fehr
- Contact Person Email
- Alexander.Fehr@med.ovgu.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 02-03-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 63
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Gyógyszerterápiás Központ, Urogenitális Tumorok és Klinikai Farmakológiai Osztály, “Kemoterápia C”
- Contact Person Name
- Lajos Géczi
- Contact Person Email
- geczi.lajos@oncol.hu
Spain
- Earliest CTIS Part Ii Submission Date
- 14-04-2026
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 14
- Number Of Sites
- 2
- Number Of Participants
- 17
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología
- Contact Person Name
- Cristina Suarez Rodriguez
- Contact Person Email
- csuarez@vhio.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncología
- Contact Person Name
- Guillermo de Velasco Oria de Rueda
- Contact Person Email
- gdevelasco.gdv@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 30-03-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 30
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Medical Oncology
- Contact Person Name
- John Haanen
- Contact Person Email
- melanoominterne@nki.nl
- Site Name
- Isala Klinieken Stichting
- Department Name
- Medical Oncology
- Contact Person Name
- Metin Tascilar
- Contact Person Email
- rioc@isala.nl
- Site Name
- Academisch Ziekenhuis Maastricht
- Department Name
- Medical Oncology
- Contact Person Name
- Maureen Aarts
- Contact Person Email
- secretariaat.medischeoncologie@mumc.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 26-03-2026
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 35
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Centrum Wsparcia Badań Klinicznych UCK Ośrodek Badań Klinicznych Wczesnych Faz
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- obkwf@uck.gda.pl
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemioterapii
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- badania.kliniczne@co.bydgoszcz.pl
Finland
- Earliest CTIS Part Ii Submission Date
- 30-03-2026
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 36
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- HUS-yhtymae
- Department Name
- Comprehensive Cancer Center
- Contact Person Name
- Katriina Jalkanen
- Contact Person Email
- katriina.jalkanen@hus.fi
- Site Name
- Tampere University Hospital
- Department Name
- Department of Oncology
- Contact Person Name
- Krista Kankaanranta
- Contact Person Email
- krista.kankaanranta@pirha.fi
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International Corp.
- Responsibilities
- EUB services (call center and medical services)
- Name
- Almac Clinical Technologies LLC
Third parties
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement and Travel Support","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Belzutifan
- Active Substance
- BELZUTIFAN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised (prodAuthStatus=1)
- Maximum Dose
- 240 mg per day (maxDailyDoseAmount=240)
- Investigational Product Name
- Lenvatinib
- Active Substance
- LENVATINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised (prodAuthStatus=1)
- Maximum Dose
- 20 mg per day (maxDailyDoseAmount=20)
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