A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)

NCT ID: NCT04195750

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 755 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-27
• Study Completion Date: 2026-09-17

Brief Summary

The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.

Detailed Description

Per protocol, all participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures.

Conditions

Carcinoma, Renal Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Belzutifan

Randomized participants received 120 mg of belzutifan orally once daily (QD), until disease progression or discontinuation.

Group Type: EXPERIMENTAL

Belzutifan

Intervention Type: DRUG

Oral tablets

Everolimus

Randomized participants received 10 mg of Everolimus orally QD, until disease progression or discontinuation.

Group Type: ACTIVE_COMPARATOR

Everolimus

Intervention Type: DRUG

Oral tablets

Safety Run-In

Non-Randomized participants enrolled into the Safety Run-in received up to 120 mg of belzutifan QD.

Group Type: EXPERIMENTAL

Belzutifan

Intervention Type: DRUG

Oral tablets

Interventions

Belzutifan

Oral tablets

Intervention Type: DRUG

Everolimus

Oral tablets

Intervention Type: DRUG

Other Intervention Names

MK-6482; WELIREG™; Afinitor; Afinitor DISPERZ; Zortress

Eligibility Criteria

Inclusion Criteria

• Has unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC)
• Has had disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with both Programmed cell death 1 ligand 1 (PD-1/L1) checkpoint inhibitor and a vascular endothelial growth factor - tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination
• Has received no more than 3 prior systemic regimens for locally advanced or metastatic RCC
• A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of study intervention
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention for those randomized to belzutifan and for at least 8 weeks after the last dose of study intervention for those randomized to everolimus
• The participant (or legally acceptable representative if applicable) has provided documented informed consent for the study
• Has adequate organ function

Exclusion Criteria

• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. (Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded)
• Has known central nervous system (CNS) metastases and/or carcinomatous meningitis. (Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks (28 days) by repeat imaging)
• Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study medication administration, or New York Heart Association Class III or IV congestive heart failure. (Medically controlled arrhythmia stable on medication is permitted)
• Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg
• Has moderate to severe hepatic impairment (Child-Pugh B or C)
• Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study
• Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption)
• Has known hypersensitivity or allergy to the active pharmaceutical ingredient or any component of the study intervention (belzutifan or everolimus) formulations
• Has received prior treatment with belzutifan or another hypoxia inducible factor 2α (HIF-2α inhibitor)
• Has received prior treatment with everolimus or any other specific or selective target of rapamycin complex 1 (TORC1)/ phosphatidylinositol 3-kinase (PI3K)/ protein kinase B (AKT) inhibitor (e.g., temsirolimus) in the advanced disease setting
• Has received any type of systemic anticancer antibody (including investigational antibody) within 4 weeks before randomization
• Has received prior radiotherapy within 2 weeks prior to randomization
• Has had major surgery within 3 weeks prior to randomization
• Has received a live vaccine within 30 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed
• Is currently receiving either strong (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study
• Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g., bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
• Is currently participating in a study of an investigational agent or is currently using an investigational device
• Has an active infection requiring systemic therapy
• Has active bacillus tuberculosis (TB)
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
• Has a known history of human immunodeficiency virus (HIV) infection. (Testing for HIV at screening is only required if mandated by local health authority
• Has a known history of Hepatitis B virus (HBV) (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (HCV) (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

University of Alabama - Birmingham ( Site 1538)

Birmingham, Alabama, United States

University of California San Diego Moores Cancer Center ( Site 1546)

La Jolla, California, United States

St Joseph Heritage Healthcare ( Site 1531)

Santa Rosa, California, United States

University Of Colorado ( Site 1540)

Aurora, Colorado, United States

UCHealth Highlands Ranch Hospital ( Site 1560)

Highlands Ranch, Colorado, United States

Sibley Memorial Hospital ( Site 1559)

Washington D.C., District of Columbia, United States

Northwest Georgia Oncology Centers PC ( Site 1520)

Marietta, Georgia, United States

The University of Chicago Medical Center ( Site 1539)

Chicago, Illinois, United States

Ochsner Medical Center ( Site 1522)

New Orleans, Louisiana, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1514)

Baltimore, Maryland, United States

Massachusetts General Hospital ( Site 1558)

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center ( Site 1501)

Boston, Massachusetts, United States

Dana Farber Cancer Institute ( Site 1505)

Boston, Massachusetts, United States

Henry Ford Cancer Center ( Site 1511)

Detroit, Michigan, United States

Hattiesburg Clinic ( Site 1509)

Hattiesburg, Mississippi, United States

St. Vincent Frontier Cancer Center ( Site 1549)

Billings, Montana, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1513)

Hackensack, New Jersey, United States

University of Rochester Medical Center ( Site 1543)

Rochester, New York, United States

University of North Carolina at Chapel Hill ( Site 1537)

Chapel Hill, North Carolina, United States

Oncology Hematology Care, Inc. ( Site 1524)

Cincinnati, Ohio, United States

Cleveland Clinic ( Site 1504)

Cleveland, Ohio, United States

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1523)

Tulsa, Oklahoma, United States

Oregon Health & Science University ( Site 1553)

Portland, Oregon, United States

Abramson Cancer Center ( Site 1525)

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center ( Site 1506)

Philadelphia, Pennsylvania, United States

Medical University of South Carolina ( Site 1518)

Charleston, South Carolina, United States

Henry Joyce Cancer Clinic ( Site 1544)

Nashville, Tennessee, United States

Texas Oncology-Austin Central ( Site 1533)

Austin, Texas, United States

Texas Oncology, P.A.-Dallas ( Site 1534)

Dallas, Texas, United States

Centro Avancado de Tratamento Oncologico ( Site 1657)

Belo Horizonte, Minas Gerais, Brazil

Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1650)

Curitiba, Paraná, Brazil

Liga Norte Riograndense Contra o Cancer ( Site 1651)

Natal, Rio Grande do Norte, Brazil

Hospital de Clinicas de Porto Alegre ( Site 1655)

Porto Alegre, Rio Grande do Sul, Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 1653)

São Paulo, , Brazil

BC Cancer - Vancouver Center ( Site 0155)

Vancouver, British Columbia, Canada

Nova Scotia Health Authority QEII-HSC ( Site 0150)

Halifax, Nova Scotia, Canada

Juravinski Cancer Centre ( Site 0154)

Hamilton, Ontario, Canada

Sunnybrook Research Institute ( Site 0153)

Toronto, Ontario, Canada

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0151)

Montreal, Quebec, Canada

CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0152)

Québec, Quebec, Canada

Bradfordhill ( Site 0003)

Santiago, Region M. de Santiago, Chile

Centro Investigación del Cáncer James Lind ( Site 0004)

Temuco, Región de la Araucanía, Chile

Fundacion Centro de Investigacion Clinica CIC ( Site 1703)

Medellín, Antioquia, Colombia

Administradora Country SA - Clinica del Country ( Site 1701)

Bogotá, Bogota D.C., Colombia

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1709)

Valledupar, Cesar Department, Colombia

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1702)

Bogota, Cundinamarca, Colombia

Oncologos del Occidente S.A. ( Site 1708)

Pereira, Risaralda Department, Colombia

Masarykuv onkologicky ustav ( Site 0105)

Brno, Brno-mesto, Czechia

Fakultni nemocnice Ostrava ( Site 0103)

Ostrava, Ostrava Mesto, Czechia

Fakultni nemocnice Hradec Kralove ( Site 0106)

Hradec Králové, , Czechia

Fakultni nemocnice Olomouc ( Site 0104)

Olomouc, , Czechia

Fakultni nemocnice Kralovske Vinohrady ( Site 0102)

Prague, , Czechia

Fakultni Thomayerova nemocnice ( Site 0107)

Prague, , Czechia

Herlev Hospital ( Site 0251)

Herlev, Capital Region, Denmark

Aarhus University Hospital Skejby ( Site 0250)

Aarhus, Central Jutland, Denmark

Kuopion Yliopistollinen Sairaala ( Site 0304)

Kuopio, Northern Savonia, Finland

Tampereen yliopistollinen sairaala ( Site 0300)

Tampere, Pirkanmaa, Finland

TYKS T-sairaala Syopatautien pkl ( Site 0301)

Turku, Southwest Finland, Finland

HYKS. ( Site 0302)

Helsinki, Uusimaa, Finland

CHU de Bordeaux Hop St ANDRE ( Site 0359)

Bordeaux, Aquitaine, France

Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0350)

Strasbourg, Bas-Rhin, France

Centre Francois Baclesse ( Site 0360)

Caen, Calvados, France

CHU Besancon - Hopital Jean Minjoz ( Site 0351)

Besançon, Doubs, France

Institut de Cancerologie du Gard - CHU Caremeau ( Site 0352)

Nîmes, Gard, France

Centre Alexis Vautrin Institut de Cancerologie de Lorraine ( Site 0356)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

Centre Hospitalier Lyon Sud ( Site 0354)

Pierre-Bénite, Rhone, France

Gustave Roussy ( Site 0353)

Villejuif, Val-de-Marne, France

Universitaetsklinik fuer Urologie ( Site 0405)

Tübingen, Baden-Wurttemberg, Germany

Universitaetsklinikum Duesseldorf ( Site 0410)

Düsseldorf, North Rhine-Westphalia, Germany

Universitaetsklinikum Essen ( Site 0401)

Essen, North Rhine-Westphalia, Germany

Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0403)

Dresden, Saxony, Germany

Universitaetsklinikum Magdeburg A.o.R. ( Site 0404)

Magdeburg, Saxony-Anhalt, Germany

Universitaetsklinikum Jena ( Site 0402)

Jena, Thuringia, Germany

Universitaetsmedizin Berlin ( Site 0400)

Berlin, , Germany

Universitatsklinikum Hamburg-Eppendorf ( Site 0408)

Hamburg, , Germany

Prince of Wales Hospital ( Site 1050)

Hong Kong, , Hong Kong

Queen Mary Hospital ( Site 1051)

Hong Kong, , Hong Kong

Queen Elizabeth Hospital. ( Site 1052)

Kowloon, , Hong Kong

Princess Margaret Hospital. ( Site 1053)

Lai Chi Kok, , Hong Kong

Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0505)

Gyula, Bekes County, Hungary

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce

Miskolc, Borsod-Abauj Zemplen county, Hungary

Semmelweis Egyetem ( Site 0501)

Budapest, , Hungary

Orszagos Onkologiai Intezet ( Site 0503)

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 0504)

Debrecen, , Hungary

Zala Megyei Szent Rafael Korhaz ( Site 0509)

Zalaegerszeg, , Hungary

Istituto Oncologico Veneto IRCCS ( Site 0603)

Padua, Veneto, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 0605

Verona, Veneto, Italy

Medical Oncology Ospedale San Donato ( Site 0609)

Arezzo, , Italy

Azienda Ospedaliera Policlinico di Bari ( Site 0610)

Bari, , Italy

Policlinico S. Orsola-Malpighi ( Site 0606)

Bologna, , Italy

Istituto Nazionale dei Tumori ( Site 0601)

Milan, , Italy

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0604)

Modena, , Italy

Fondazione Salvatore Maugeri clinica del lavoro ( Site 0600)

Pavia, , Italy

Fondazione Policlinico Universitario A. Gemelli ( Site 0607)

Roma, , Italy

Azienda Ospedaliera Santa Maria ( Site 0602)

Terni, , Italy

Fujita Health University ( Site 1016)

Toyoake, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 1001)

Kashiwa, Chiba, Japan

Ehime University Hospital ( Site 1014)

Tōon, Ehime, Japan

Sapporo Medical University Hospital ( Site 1008)

Sapporo, Hokkaido, Japan

Yokohama City University Hospital ( Site 1015)

Yokohama, Kanagawa, Japan

Kanagawa cancer center ( Site 1021)

Yokohama, Kanagawa, Japan

Nara Medical University Hospital ( Site 1009)

Kashihara, Nara, Japan

Kindai University Hospital- Osakasayama Campus-Urology ( Site 1011)

Sayama, Osaka, Japan

Osaka University Hospital ( Site 1006)

Suita, Osaka, Japan

Saitama Medical University International Medical Center ( Site 1012)

Hidaka, Saitama, Japan

Hamamatsu University Hospital ( Site 1005)

Hamamatsu, Shizuoka, Japan

Toyama University Hospital ( Site 1013)

Toyoma, Toyama, Japan

Yamaguchi University Hospital ( Site 1018)

Ube, Yamaguchi, Japan

Kyushu University Hospital ( Site 1007)

Fukuoka, , Japan

Hiroshima University Hospital-Hiroshima University Hospital ( Site 1019)

Hiroshima, , Japan

Niigata University Medical & Dental Hospital ( Site 1022)

Niigata, , Japan

Okayama University Hospital ( Site 1020)

Okayama, , Japan

Tokushima University Hospital-Department of Urology ( Site 1017)

Tokushima, , Japan

National Cancer Center Hospital ( Site 1003)

Tokyo, , Japan

Toranomon Hospital ( Site 1004)

Tokyo, , Japan

Nippon Medical School Hospital ( Site 1010)

Tokyo, , Japan

The Cancer Institute Hospital of JFCR ( Site 1000)

Tokyo, , Japan

Keio University Hospital ( Site 1002)

Tokyo, , Japan

Akershus universitetssykehus ( Site 0851)

Lorenskog, Akershus, Norway

Helse Bergen HF - Haukeland Universitetssykehus ( Site 0854)

Bergen, Hordaland, Norway

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1151)

Krasnoyarsk, Krasnoyarsk Krai, Russia

SBIH City clinical hospital named after D.D. Pletniov ( Site 1160)

Moscow, Moscow, Russia

N.N. Blokhin NMRCO ( Site 1156)

Moscow, Moscow, Russia

Russian Scientific Center of Roentgenoradiology ( Site 1155)

Moscow, Moscow, Russia

First Moscow State Medical University n.a. I.M.Sechenov ( Site 1163)

Moscow, Moscow, Russia

Central Clinical Hospital with Polyclinic ( Site 1157)

Moscow, Moscow, Russia

Hadassah Medical-Oncology department ( Site 1164)

Moscow, Moscow Oblast, Russia

Omsk Clinical Oncology Dispensary ( Site 1150)

Omsk, Omsk Oblast, Russia

Russian Scientific Center of Radiology and Surgical Technologies ( Site 1153)

Saint Petersburg, Sankt-Peterburg, Russia

SBHI SPb Clinical Research Centre of specialized types of medical care ( Site 1159)

Saint Petersburg, Sankt-Peterburg, Russia

City clinical oncological dispensary ( Site 1154)

Saint Petersburg, Sankt-Peterburg, Russia

National Cancer Center ( Site 1204)

Gyeonggi-do, Kyonggi-do, South Korea

Chungnam National University Hospital ( Site 1205)

Daejeon, Taejon-Kwangyokshi, South Korea

Korea University Anam Hospital ( Site 1203)

Seoul, , South Korea

Severance Hospital Yonsei University Health System ( Site 1202)

Seoul, , South Korea

Asan Medical Center ( Site 1200)

Seoul, , South Korea

Samsung Medical Center ( Site 1201)

Seoul, , South Korea

Instituto Catalan de Oncologia - ICO ( Site 1251)

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitari Vall d Hebron ( Site 1250)

Barcelona, Catalonia, Spain

Hospital General Universitario 12 de Octubre ( Site 1252)

Madrid, Madrid, Comunidad de, Spain

Instituto Valenciano de Oncologia - IVO ( Site 1254)

Valencia, Valenciana, Comunitat, Spain

Hospital Ramon y Cajal ( Site 1253)

Madrid, , Spain

Laenssjukhuset Ryhov ( Site 1853)

Jönköping, Jönköping County, Sweden

Malmo Universitetssjukhus ( Site 1851)

Malmo, Skåne County, Sweden

Karolinska Universitetssjukhuset Solna ( Site 1850)

Stockholm, Stockholm County, Sweden

Norrlands Universitetssjukhus ( Site 1856)

Umeå, Västerbotten County, Sweden

Chang Gung Medical Foundation - Kaohsiung ( Site 1104)

Kaohsiung City, , Taiwan

Taichung Veterans General Hospital ( Site 1105)

Taichung, , Taiwan

National Cheng Kung University Hospital ( Site 1103)

Tainan City, , Taiwan

National Taiwan University Hospital ( Site 1100)

Taipei, , Taiwan

Taipei Veterans General Hospital ( Site 1101)

Taipei, , Taiwan

Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1106)

Taoyuan District, , Taiwan

Ankara Universitesi Tip Fakultesi ( Site 1311)

Ankara, , Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi ( Site 1300)

Ankara, , Turkey (Türkiye)

Gazi Universitesi Tip Fakultesi ( Site 1308)

Ankara, , Turkey (Türkiye)

Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1302)

Edirne, , Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1305)

Istanbul, , Turkey (Türkiye)

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1303)

Istanbul, , Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi ( Site 1304)

Izmir, , Turkey (Türkiye)

Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 1306)

Izmir, , Turkey (Türkiye)

MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 1453)

Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine

MI Precarpathian Clinical Oncology Center ( Site 1452)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Kyiv City Clinical Oncology Center ( Site 1450)

Kyiv, Kyivska Oblast, Ukraine

Cambridge University Hospitals NHSFT ( Site 1405)

Cambridge, Cambridgeshire, United Kingdom

Western General Hospital ( Site 1400)

Edinburgh, Edinburgh, City of, United Kingdom

The Beatson West of Scotland Cancer Centre ( Site 1402)

Glasgow, Glasgow City, United Kingdom

Barts Health NHS Trust ( Site 1407)

London, London, City of, United Kingdom

Royal Marsden NHS Foundation Trust ( Site 1403)

London, London, City of, United Kingdom

Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1409)

London, London, City of, United Kingdom

Royal Marsden Hospital Sutton-Surrey ( Site 1411)

Sutton, Surrey, United Kingdom

Medway Maritime Hospital ( Site 1406)

Gillingham, , United Kingdom

The Christie NHS Foundation Trust ( Site 1401)

Manchester, , United Kingdom

Countries

United States; Brazil; Canada; Chile; Colombia; Czechia; Denmark; Finland; France; Germany; Hong Kong; Hungary; Italy; Japan; Norway; Russia; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

References

Choueiri TK, Powles T, Peltola K, de Velasco G, Burotto M, Suarez C, Ghatalia P, Iacovelli R, Lam ET, Verzoni E, Gumus M, Stadler WM, Kollmannsberger C, Melichar B, Venugopal B, Gross-Goupil M, Poprach A, De Santis M, Schutz FA, Park SH, Nosov DA, Porta C, Lee JL, Garcia-Del-Muro X, Biscaldi E, Manneh Kopp R, Oya M, He L, Wang A, Perini RF, Vickery D, Albiges L, Rini B; LITESPARK-005 Investigators. Belzutifan versus Everolimus for Advanced Renal-Cell Carcinoma. N Engl J Med. 2024 Aug 22;391(8):710-721. doi: 10.1056/NEJMoa2313906.

Reference Type: RESULT

PMID: 39167807 (View on PubMed)

Powles T, Choueiri TK, Albiges L, Peltola K, de Velasco G, Burotto M, Suarez C, Ghatalia P, Iacovelli R, Lam ET, Verzoni E, Gumus M, Stadler WM, Kollmannsberger C, Melichar B, Venugopal B, Gross-Goupil M, Poprach A, De Santis M, Rizzo M, Shinde R, Saretsky TL, He L, Perini RF, Vickery D, Rini B. Health-related quality of life with belzutifan versus everolimus for advanced renal cell carcinoma (LITESPARK-005): patient-reported outcomes from a randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Apr;26(4):491-502. doi: 10.1016/S1470-2045(25)00032-4. Epub 2025 Mar 17.

Reference Type: DERIVED

PMID: 40112850 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26230&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

MK-6482

Identifier Type: OTHER

Identifier Source: secondary_id

205262

Identifier Type: REGISTRY

Identifier Source: secondary_id

jRCT2080225166

Identifier Type: OTHER

Identifier Source: secondary_id

2023-506635-15

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1294-1321

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-003444-72

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

6482-005

Identifier Type: -

Identifier Source: org_study_id