Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
155
Countries
10
Sites
17
Renal Cell Carcinoma, hepatocellular carcinoma, nonMSI-H/dMMR colorectal cancer, pancreatic ductal adenocarcinoma, biliary tract cancer, non-MSIH/dMMR endometrial cancer, esophageal squamous cell carcinoma, Advanced Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, von Hippel-Lindau (VHL)Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor, Advanced Solid Tumors With HIF-2α related Genetic Alterations
To assess OS in Cohort A and Cohort B
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 May 2026 → ongoing
- Decision date (initial)
- 2026-04-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2025-524160-38-00
- WHO UTN
- U1111-1325-4582
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Safety
To assess OS in Cohort A and Cohort B
Secondary objectives 1
- To evaluate safety and tolerability in all cohorts
Conditions and MedDRA coding
Renal Cell Carcinoma, hepatocellular carcinoma, nonMSI-H/dMMR colorectal cancer, pancreatic ductal adenocarcinoma, biliary tract cancer, non-MSIH/dMMR endometrial cancer, esophageal squamous cell carcinoma, Advanced Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, von Hippel-Lindau (VHL)Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor, Advanced Solid Tumors With HIF-2α related Genetic Alterations
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10062427 | Gastrointestinal stromal tumor | 10029104 |
| 21.0 | LLT | 10055476 | Esophageal squamous cell carcinoma | 10029104 |
| 21.1 | PT | 10067946 | Renal cell carcinoma | 100000004864 |
| 20.1 | LLT | 10034876 | Pheochromocytoma | 10029104 |
| 20.0 | PT | 10004593 | Bile duct cancer | 100000004864 |
| 21.0 | LLT | 10067518 | Pancreatic neuroendocrine tumor | 10029104 |
| 20.0 | LLT | 10073860 | Paraganglioma | 10029104 |
| 20.0 | LLT | 10065794 | Muscle weakness right-sided | 10029205 |
| 23.1 | LLT | 10049749 | Post procedural pain | 10022117 |
| 20.0 | PT | 10073364 | Ductal adenocarcinoma of pancreas | 100000004864 |
| 21.1 | LLT | 10049010 | Carcinoma hepatocellular | 10029104 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 21.0 | PT | 10014733 | Endometrial cancer | 100000004864 |
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-502123-21-00 | Phase 2 Study of MK-6482 in Participants With Advanced Renal Cell Carcinoma | Merck Sharp & Dohme LLC |
| 2023-506839-15-00 | A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03B | Merck Sharp & Dohme LLC |
| 2023-506838-68-00 | A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03): Substudy 03A | Merck Sharp & Dohme LLC |
| 2023-506635-15-00 | An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants with Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies | Merck Sharp & Dohme LLC |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 2
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Overall survival (OS)
Secondary endpoints 2
- Number of Participants Who Experience One or More Adverse Events (AEs)
- Number of Participants Who Discontinue Study Treatment Due to AEs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD9394756 · Product
- Active substance
- Belzutifan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 175200 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9414231 · Product
- Active substance
- Lenvatinib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14600 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9414230 · Product
- Active substance
- Lenvatinib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14600 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jelena Todoric
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jelena Todoric
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
Locations
10 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruiting | 1 | 1 |
| Czechia | Authorised, recruiting | 2 | 1 |
| Denmark | Authorised, recruitment pending | 1 | 1 |
| Finland | Authorised, recruitment pending | 2 | 2 |
| France | Authorised, recruitment pending | 4 | 3 |
| Germany | Authorised, recruitment pending | 1 | 1 |
| Hungary | Authorised, recruiting | 1 | 1 |
| Netherlands | Authorised, recruiting | 4 | 3 |
| Poland | Authorised, recruitment pending | 4 | 2 |
| Spain | Ongoing, recruiting | 17 | 2 |
| Rest of world
Russian Federation, Australia, Brazil, Korea, Democratic People's Republic of, Canada, Colombia, New Zealand, United Kingdom, Chile, Israel, Ukraine, United States, Japan, Taiwan
|
— | 118 | — |
Investigational sites
HUS-yhtymae
Comprehensive Cancer Center, Haartmaninkatu 4, 00290, Helsinki
Tampere University Hospital
Department of Oncology, Elamanaukio 2, 33520, Tampere
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Les Hopitaux Universitaires De Strasbourg
Medical Oncology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Oncopole Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Universitaetsklinikum Magdeburg AöR
"Klinik für Urologie, Uro-Onkologie, robotergestützte und fokale Therapie ", Leipziger Strasse 44, 39120, Magdeburg
Orszagos Onkologiai Intezet
Gyógyszerterápiás Központ, Urogenitális Tumorok és Klinikai Farmakológiai Osztály, “Kemoterápia C”, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Isala Klinieken Stichting
Medical Oncology, Dokter Van Heesweg 2, 8025 AB, Zwolle
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Academisch Ziekenhuis Maastricht
Medical Oncology, P Debyelaan 25, 6229 HX, Maastricht
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2026-05-18 | ||||
| Czechia | 2026-05-28 | ||||
| Hungary | 2026-05-28 | ||||
| Netherlands | 2026-05-26 | ||||
| Spain | 2026-05-12 | 2026-05-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 54 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-524160-38_IN_for pub | 00R |
| Recruitment arrangements (for publication) | K1_Patient ID Card_OOS_HUN_HU_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_BEL_EN_IN_for pub | 08DEC2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_CZE_CS_IN_for pub | 12DEC2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DNK_EN_IN-RFI012_for pub | 1-0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_ES_IN_for pub | 6R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FIN_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_IN_for pub | 08DEC2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_HUN_EN_IN_for pub | 09DEC2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_NLD_EN_IN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_IN_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_BEL_EN_IN_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_BEL_FR_IN_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_BEL_NL_IN_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_CZE_CS_IN-RFI002_for pub | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_DNK_DA_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_ESP_ES_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_FIN_FI_IN-RFI010_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_FRA_FR_IN_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_HUN_HU_IN-RFI005_for pub | 0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_NLD_NL_IN_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum disease progression_POL_PL_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_EN_IN-RFI007_for pub | 0-00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_FR_IN-RFI007_for pub | 0-00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_NL_IN-RFI007_for pub | 0-0R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_CZE_CS_IN-RFI002_for pub | 1R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DEU_DE_IN-RFI009_for pub | 0-02R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DNK_DA_IN-RFI012_for pub | 02R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_IN-RFI015_for pub | 02R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FIN_FI_NSM02_for pub | 0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_IN-RFI006_for pub | 0-00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_HUN_HU_IN-RFI005_for pub | 0-00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_NLD_NL_IN-RFI013_for pub | 0-00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_POL_PL_IN-RFI008_for pub | 02R |
| Subject information and informed consent form (for publication) | L1_ICF_Main GDPR_CZE_CS_IN_for pub | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_addendum_progression consent_DEU_DE_IN_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_ESP_ES_IN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_ESP_ES_IN_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnant partner_HUN_HU_IN-RFI005_for pub | 0-00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_right not to know_DNK_DA_IN_for pub | 00 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-523176-23_DEU_DE_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524160-38_BEL_DE_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524160-38_BEL_FR_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524160-38_BEL_NL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524160-38_CZE_CS_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524160-38_ESP_ES_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524160-38_FRA_FR_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524160-38_HUN_HU_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524160-38_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524160-38_NLD_NL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-524160-38_POL_PL_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2025-524160-38_CZE_CS_IN_for pub | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2025-524160-38_HUN_HU_IN_for pub | 00 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-19 | Poland | Acceptable with conditions 2026-04-27
|
2026-04-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-05 | Acceptable with conditions 2026-04-27
|
2026-05-05 |