Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

June 4, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, Formerly PT2977) Monotherapy in Participants With Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With HIF-2α Related Genetic Alterations

This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

355

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Prince of Wales Hospital-Medical Oncology ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: +61402035933
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • The Royal Melbourne Hospital ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: +61 3 9342 7143
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203)
        • Contact:
          • Study Coordinator
          • Phone Number: 403-521-3165
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-946-4501 x6508
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP ( Site 2200)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224205098
      • Santiago, Region M. de Santiago, Chile, 7560908
        • Recruiting
        • Centro de Oncología de Precisión ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: +56225189885
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Active, not recruiting
        • Peking University First Hospital-Urology ( Site 1900)
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Active, not recruiting
        • Sun Yat-sen University Cancer Center ( Site 1905)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200001
        • Active, not recruiting
        • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Completed
        • West China Hospital of Sichuan University ( Site 1906)
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Recruiting
        • Rigshospitalet ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 35453545
      • Copenhagen, Capital Region, Denmark, 2100
        • Recruiting
        • Rigshospitalet-Department of Endocrinology ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: 35457562
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +45 66 11 33 33
  • France
      • Paris, France, 75014
        • Recruiting
        • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: +33158411439
    • Alsace
      • Strasbourg, Alsace, France, 67098
        • Recruiting
        • CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: +(0)3 88 12 75 93
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69003
        • Recruiting
        • Hôpital Edouard Herriot-oncologie ( Site 0405)
        • Contact:
          • Study Coordinator
          • Phone Number: +33472119692
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13009
        • Active, not recruiting
        • Institut Paoli-Calmettes-Oncology ( Site 0406)
    • Paris
      • Le Kremlin-Bicêtre, Paris, France, 94270
        • Recruiting
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)
        • Contact:
          • Study Coordinator
          • Phone Number: 0145217453
    • Île-de-France Region
      • Villejuif, Île-de-France Region, France, 94805
        • Recruiting
        • Gustave Roussy ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: +33142114211
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930450614303
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Recruiting
        • Universitaetsklinikum Freiburg ( Site 0504)
        • Contact:
          • Study Coordinator
          • Phone Number: +49761270-32613
    • Bavaria
      • München, Bavaria, Germany, 80336
        • Completed
        • Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division ( Site 0501)
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)
        • Contact:
          • Study Coordinator
          • Phone Number: 49-0931-20 13 90 21
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Recruiting
        • Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 211 81 08030
  • Hungary
      • Budapest, Hungary, 1083
        • Recruiting
        • Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)
        • Contact:
          • Study Coordinator
          • Phone Number: +3614591500
  • Israel
      • Ramat Gan, Israel, 5262100
        • Recruiting
        • Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235303030
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +97236972062
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708)
        • Contact:
          • Study Coordinator
          • Phone Number: + 39 051 2142708
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: +390303995410
      • Milan, Italy, 20132
        • Completed
        • Ospedale San Raffaele-Oncologia Medica ( Site 0705)
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe ( Site 0700)
        • Contact:
          • Study Coordinator
          • Phone Number: +390257489258
      • Verona, Italy, 37134
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)
        • Contact:
          • Study Coordinator
          • Phone Number: +390458128131
    • Campania
      • Naples, Campania, Italy, 80100
        • Completed
        • University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi ( Site 0709)
        • Contact:
          • Study Coordinator
          • Phone Number: 0223902182
    • Tuscany
      • Siena, Tuscany, Italy, 53100
        • Recruiting
        • Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 0706)
        • Contact:
          • Study Coordinator
          • Phone Number: +39057758636
  • Japan
      • Kyoto, Japan, 606-8507
        • Active, not recruiting
        • Kyoto University Hospital ( Site 1806)
      • Tokyo, Japan, 123-8558
        • Active, not recruiting
        • Tokyo Women's Medical University Adachi Medical Center ( Site 1803)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Active, not recruiting
        • Hokkaido University Hospital ( Site 1800)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0004
        • Active, not recruiting
        • Yokohama City University Hospital ( Site 1804)
    • Kochi
      • Nankoku, Kochi, Japan, 783-8505
        • Active, not recruiting
        • Kochi Medical School Hospital ( Site 1807)
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Active, not recruiting
        • National Cancer Center Hospital ( Site 1802)
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitair Medisch Centrum Utrecht ( Site 1530)
        • Contact:
          • Study Coordinator
          • Phone Number: 31887556308
  • Norway
      • Oslo, Norway, 0424
        • Recruiting
        • Oslo Universitetssykehus Radiumhospitalet ( Site 2400)
        • Contact:
          • Study Coordinator
          • Phone Number: +4722934000
  • Portugal
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2600)
        • Contact:
          • Study Coordinator
          • Phone Number: (351) 225 084 000
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1649-035
        • Recruiting
        • START Lisbon - Hospital de Santa Maria ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: +351 21 780 5000
  • Russia
    • Baskortostan, Respublika
      • Ufa, Baskortostan, Respublika, Russia, 450054
        • Completed
        • GBUZ Republican Clinical Oncological Dispensary ( Site 0804)
    • Leningradskaya Oblast'
      • Saint Petersburg, Leningradskaya Oblast', Russia, 190020
        • Completed
        • Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov ( Site 0805)
      • Saint Petersburg, Leningradskaya Oblast', Russia, 198255
        • Recruiting
        • Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)
        • Contact:
          • Study Coordinator
          • Phone Number: +79675231218
    • Moscow
      • Moscow, Moscow, Russia, 115522
        • Recruiting
        • Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: +74993244383
      • Moscow, Moscow, Russia, 117036
        • Completed
        • Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore ( Site 1700)
        • Contact:
          • Study Coordinator
          • Phone Number: +65 64368000
  • South Korea
    • Seoul
      • Jongno-gu, Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-2072-3618
      • Songpa-gu, Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-3010-3266
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: 34934894350
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28033
        • Completed
        • MD Anderson Cancer Center-Oncology ( Site 1102)
      • Madrid, Madrid, Comunidad de, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: 34913908926
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: 34646662756
  • Sweden
    • Skåne County
      • Lund, Skåne County, Sweden, 221 85
        • Recruiting
        • Skanes University Hospital Lund ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: +4646171000
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 76
        • Completed
        • Karolinska Universitetssjukhuset Solna ( Site 1202)
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 751 85
        • Recruiting
        • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +46186110000
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +46313421000
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universitesi-oncology hospital ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: 00903123052910
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi. ( Site 0904)
        • Contact:
          • Study Coordinator
          • Phone Number: 0090312 552 60 00
      • Istanbul, Turkey (Türkiye), 34668
        • Completed
        • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)
    • Adana
      • Yüreğir, Adana, Turkey (Türkiye), 01250
        • Recruiting
        • Baskent University Adana Training Hospital ( Site 0906)
        • Contact:
          • Study Coordinator
          • Phone Number: +904449901
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege University Medicine of Faculty ( Site 0900)
        • Contact:
          • Study Coordinator
          • Phone Number: 00902323903911
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital ( Site 1309)
        • Contact:
          • Study Coordinator
          • Phone Number: +441223245151
    • England
      • London, England, United Kingdom, NW3 2QG
        • Active, not recruiting
        • Royal Free Hospital ( Site 1302)
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Recruiting
        • The Beatson West of Scotland Cancer Centre ( Site 1308)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 141 301 7055
    • London, City of
      • London, London, City of, United Kingdom, W12 OHS
        • Recruiting
        • Hammersmith Hospital-Medical Oncology ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: 0208 383 3089
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center ( Site 0110)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-967-2781
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)
        • Contact:
          • Study Coordinator
          • Phone Number: 312-695-1310
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center - Warrenville ( Site 0134)
        • Contact:
          • Study Coordinator
          • Phone Number: 312-695-1310
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa ( Site 0104)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-356-2148
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)
        • Contact:
          • Study Coordinator
          • Phone Number: 410-502-5140
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health ( Site 0125)
        • Contact:
          • Study Coordinator
          • Phone Number: 240-858-3851
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital ( Site 0111)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-724-4000
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan ( Site 0126)
        • Contact:
          • Study Coordinator
          • Phone Number: 734-647-8902
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Active, not recruiting
        • Washington University-Internal Medicine/Oncology ( Site 0124)
    • New York
      • New York, New York, United States, 10029
        • Active, not recruiting
        • Icahn School of Medicine at Mount Sinai ( Site 0123)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Active, not recruiting
        • Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center ( Site 0107)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-811-8480
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners ( Site 7000)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-329-7274
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center ( Site 0112)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-792-2841

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

The main inclusion criteria include but are not limited to the following:

  • Male and female participants at least 12 years of age (at least 18 years of age for Cohort B1)
  • Diagnosis of one of the following: Advanced/metastatic pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumors (pNET), von Hippel-Lindau (VHL) disease associated localized tumors, or advanced wild-type gastrointestinal stromal tumor (wt GIST) or advanced solid tumors with Hypoxia Inducible Factor- 2 alpha subunit (HIF-2α) related genetic alterations

  • Cohort B1: VHL Disease-associated tumors:

    • Have a diagnosis of VHL disease as determined by a germline test locally and/or clinical diagnosis
    • Must be ≥18 years of age
  • Has a life expectancy of at least 3 months

The main exclusion criteria include but are not limited to the following:

  • Unable to swallow orally administered medication or has a disorder that might affect the absorption of belzutifan
  • History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
  • Any of the following: A pulse oximeter reading <92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
  • Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, or arterial bypass (CABG) or Percutaneous transluminal coronary angioplasty (PTCA) ≤6 months from study entry, or New York Heart Association Class III or IV congestive heart failure
  • Received prior treatment (except somatostatin analogs) with chemotherapy, targeted therapy, biologics, or other investigational therapy within the past 4 weeks of first dose of study intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Belzutifan
Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Drug: Belzutifan
Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Other Names:
  • MK-6482
  • WELIREG™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 5.5 years
ORR is the percentage of participants with complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression) or death due to any cause, whichever occurs first.
Up to approximately 5.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) as Assessed by BICR
Time Frame: Up to approximately 5.5 years
DOR is the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Up to approximately 5.5 years
Time to Response (TTR) as Assessed by BICR
Time Frame: Up to approximately 5.5 years
TTR is defined as the time from first dose of belzutifan to first documented evidence of CR or PR.
Up to approximately 5.5 years
Disease Control Rate (DCR) as Assessed by BICR
Time Frame: Up to approximately 5.5 years
Disease control is a confirmed CR, PR, or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study).
Up to approximately 5.5 years
Progressive Free Survival (PFS) as Assessed by BICR
Time Frame: Up to approximately 5.5 years
PFS is the time from first dose of belzutifan to the first documented PD or death from any cause, whichever occurs first.
Up to approximately 5.5 years
Overall Survival (OS)
Time Frame: Up to approximately 5.5 years
OS is the time from first dose of belzutifan until death from any cause.
Up to approximately 5.5 years
Time to Surgery (TTS)
Time Frame: Up to approximately 5.5 years
TTS is defined as the time from the first dose of belzutifan to the first documented surgical intervention or tumor reduction procedure.
Up to approximately 5.5 years
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 5.5 years
An AE is 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 is considered related to the medical treatment or procedure, that occurs during the course of the study.
Up to approximately 5.5 years
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 5.5 years
An adverse event (AE) is 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 is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinue study treatment due to an AE will be presented.
Up to approximately 5.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2021

Primary Completion (Estimated)

December 27, 2029

Study Completion (Estimated)

December 27, 2029

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6482-015
  • MK-6482-015 (Other Identifier: MSD)
  • PT2977 (Other Identifier: Former name)
  • jRCT2011220024 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
  • 2020-005028-13 (EudraCT Number)
  • 2023-504853-11-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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