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

NCT04195750 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 7 other identifiers: 6482-005MK-6482205262jRCT20802251662023-506635-15U1111-1294-13212019-003444-72
• Study Type: interventional
• Target: 755
• Locations: 23 countries
• Sites: 172

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.

Conditions

Carcinoma, Renal Cell

Keywords

Hypoxia inducible Factor (HIF); Hypoxia inducible factor 1B (HIF-1B); Hypoxia inducible factor 2 alpha (HIF-2 alpha); Hypoxia inducible factor 2α (HIF-2α); Renal Cell Carcinoma (RCC); Kidney Cancer; PT-2977; PT2977; MK6482

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review is presented here.

  Up to approximately 39 months

• Overall Survival (OS)

  OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.

  Up to approximately 49 months

Secondary Outcomes (11)

• Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR

  Up to approximately 31 months

• Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR

  Up to approximately 49 months

• Number of Participants Who Experience One or More Adverse Events (AEs)

  Up to approximately 78 months

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 78 months

• Time to True Deterioration (TTD) in Health-Related Quality-of-Life (HRQoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Combined Score

  Up to approximately 39 months

Study Arms (3)

Belzutifan

EXPERIMENTAL

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

Drug: Belzutifan

Everolimus

ACTIVE COMPARATOR

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

Drug: Everolimus

Safety Run-In

EXPERIMENTAL

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

Drug: Belzutifan

Interventions

Belzutifan DRUG

Oral tablets

Also known as: MK-6482, WELIREG™

Belzutifan; Safety Run-In

Everolimus DRUG

Oral tablets

Also known as: Afinitor, Afinitor DISPERZ, Zortress

Everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (172)

University of Alabama - Birmingham ( Site 1538)

Birmingham, Alabama, 35294, United States

Location

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

La Jolla, California, 92093-0698, United States

Location

St Joseph Heritage Healthcare ( Site 1531)

Santa Rosa, California, 95403, United States

Location

University Of Colorado ( Site 1540)

Aurora, Colorado, 80045, United States

Location

UCHealth Highlands Ranch Hospital ( Site 1560)

Highlands Ranch, Colorado, 80129, United States

Location

Sibley Memorial Hospital ( Site 1559)

Washington D.C., District of Columbia, 20016, United States

Location

Northwest Georgia Oncology Centers PC ( Site 1520)

Marietta, Georgia, 30060, United States

Location

The University of Chicago Medical Center ( Site 1539)

Chicago, Illinois, 60637, United States

Location

Ochsner Medical Center ( Site 1522)

New Orleans, Louisiana, 70121, United States

Location

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

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital ( Site 1558)

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center ( Site 1501)

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute ( Site 1505)

Boston, Massachusetts, 02215, United States

Location

Henry Ford Cancer Center ( Site 1511)

Detroit, Michigan, 48202, United States

Location

Hattiesburg Clinic ( Site 1509)

Hattiesburg, Mississippi, 39401, United States

Location

St. Vincent Frontier Cancer Center ( Site 1549)

Billings, Montana, 59102, United States

Location

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

Hackensack, New Jersey, 07601, United States

Location

University of Rochester Medical Center ( Site 1543)

Rochester, New York, 14620, United States

Location

University of North Carolina at Chapel Hill ( Site 1537)

Chapel Hill, North Carolina, 27514, United States

Location

Oncology Hematology Care, Inc. ( Site 1524)

Cincinnati, Ohio, 45242, United States

Location

Cleveland Clinic ( Site 1504)

Cleveland, Ohio, 44195, United States

Location

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

Tulsa, Oklahoma, 74146, United States

Location

Oregon Health & Science University ( Site 1553)

Portland, Oregon, 97232, United States

Location

Abramson Cancer Center ( Site 1525)

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center ( Site 1506)

Philadelphia, Pennsylvania, 19111, United States

Location

Medical University of South Carolina ( Site 1518)

Charleston, South Carolina, 29425, United States

Location

Henry Joyce Cancer Clinic ( Site 1544)

Nashville, Tennessee, 37232, United States

Location

Texas Oncology-Austin Central ( Site 1533)

Austin, Texas, 78731, United States

Location

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

Dallas, Texas, 75230, United States

Location

Centro Avancado de Tratamento Oncologico ( Site 1657)

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

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

Curitiba, Paraná, 80510-130, Brazil

Location

Liga Norte Riograndense Contra o Cancer ( Site 1651)

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Hospital de Clinicas de Porto Alegre ( Site 1655)

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 1653)

São Paulo, 01321-030, Brazil

Location

BC Cancer - Vancouver Center ( Site 0155)

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Nova Scotia Health Authority QEII-HSC ( Site 0150)

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre ( Site 0154)

Hamilton, Ontario, L8V 5C2, Canada

Location

Sunnybrook Research Institute ( Site 0153)

Toronto, Ontario, M4N 3M5, Canada

Location

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

Montreal, Quebec, H2X 3E4, Canada

Location

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

Québec, Quebec, G1R 2J6, Canada

Location

Bradfordhill ( Site 0003)

Santiago, Region M. de Santiago, 8420383, Chile

Location

Centro Investigación del Cáncer James Lind ( Site 0004)

Temuco, Región de la Araucanía, Temuco, Chile

Location

Fundacion Centro de Investigacion Clinica CIC ( Site 1703)

Medellín, Antioquia, 050021, Colombia

Location

Administradora Country SA - Clinica del Country ( Site 1701)

Bogotá, Bogota D.C., 110221, Colombia

Location

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

Valledupar, Cesar Department, 200001, Colombia

Location

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

Bogota, Cundinamarca, 111321, Colombia

Location

Oncologos del Occidente S.A. ( Site 1708)

Pereira, Risaralda Department, 660001, Colombia

Location

Masarykuv onkologicky ustav ( Site 0105)

Brno, Brno-mesto, 656 53, Czechia

Location

Fakultni nemocnice Ostrava ( Site 0103)

Ostrava, Ostrava Mesto, 708 52, Czechia

Location

Fakultni nemocnice Hradec Kralove ( Site 0106)

Hradec Králové, 500 05, Czechia

Location

Fakultni nemocnice Olomouc ( Site 0104)

Olomouc, 779 00, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady ( Site 0102)

Prague, 100 34, Czechia

Location

Fakultni Thomayerova nemocnice ( Site 0107)

Prague, 140 59, Czechia

Location

Herlev Hospital ( Site 0251)

Herlev, Capital Region, 2730, Denmark

Location

Aarhus University Hospital Skejby ( Site 0250)

Aarhus, Central Jutland, 8200, Denmark

Location

Kuopion Yliopistollinen Sairaala ( Site 0304)

Kuopio, Northern Savonia, 70210, Finland

Location

Tampereen yliopistollinen sairaala ( Site 0300)

Tampere, Pirkanmaa, 33520, Finland

Location

TYKS T-sairaala Syopatautien pkl ( Site 0301)

Turku, Southwest Finland, 20521, Finland

Location

HYKS. ( Site 0302)

Helsinki, Uusimaa, 00290, Finland

Location

CHU de Bordeaux Hop St ANDRE ( Site 0359)

Bordeaux, Aquitaine, 33075, France

Location

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

Strasbourg, Bas-Rhin, 67200, France

Location

Centre Francois Baclesse ( Site 0360)

Caen, Calvados, 14076, France

Location

CHU Besancon - Hopital Jean Minjoz ( Site 0351)

Besançon, Doubs, 25000, France

Location

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

Nîmes, Gard, 30029, France

Location

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

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54519, France

Location

Centre Hospitalier Lyon Sud ( Site 0354)

Pierre-Bénite, Rhone, 69310, France

Location

Gustave Roussy ( Site 0353)

Villejuif, Val-de-Marne, 94800, France

Location

Universitaetsklinik fuer Urologie ( Site 0405)

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitaetsklinikum Duesseldorf ( Site 0410)

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Universitaetsklinikum Essen ( Site 0401)

Essen, North Rhine-Westphalia, 45122, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0403)

Dresden, Saxony, 01307, Germany

Location

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

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Universitaetsklinikum Jena ( Site 0402)

Jena, Thuringia, 07747, Germany

Location

Universitaetsmedizin Berlin ( Site 0400)

Berlin, 10117, Germany

Location

Universitatsklinikum Hamburg-Eppendorf ( Site 0408)

Hamburg, 20246, Germany

Location

Prince of Wales Hospital ( Site 1050)

Hong Kong, Hong Kong

Location

Queen Mary Hospital ( Site 1051)

Hong Kong, Hong Kong

Location

Queen Elizabeth Hospital. ( Site 1052)

Kowloon, Hong Kong

Location

Princess Margaret Hospital. ( Site 1053)

Lai Chi Kok, Hong Kong

Location

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

Gyula, Bekes County, H-5700, Hungary

Location

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

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

Location

Semmelweis Egyetem ( Site 0501)

Budapest, 1085, Hungary

Location

Orszagos Onkologiai Intezet ( Site 0503)

Budapest, 1122, Hungary

Location

Debreceni Egyetem Klinikai Kozpont ( Site 0504)

Debrecen, 4032, Hungary

Location

Zala Megyei Szent Rafael Korhaz ( Site 0509)

Zalaegerszeg, 8900, Hungary

Location

Istituto Oncologico Veneto IRCCS ( Site 0603)

Padua, Veneto, 35128, Italy

Location

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

Verona, Veneto, 37126, Italy

Location

Medical Oncology Ospedale San Donato ( Site 0609)

Arezzo, 52100, Italy

Location

Azienda Ospedaliera Policlinico di Bari ( Site 0610)

Bari, 70124, Italy

Location

Policlinico S. Orsola-Malpighi ( Site 0606)

Bologna, 40138, Italy

Location

Istituto Nazionale dei Tumori ( Site 0601)

Milan, 20133, Italy

Location

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0604)

Modena, 41125, Italy

Location

Fondazione Salvatore Maugeri clinica del lavoro ( Site 0600)

Pavia, 27100, Italy

Location

Fondazione Policlinico Universitario A. Gemelli ( Site 0607)

Roma, 00168, Italy

Location

Azienda Ospedaliera Santa Maria ( Site 0602)

Terni, 05100, Italy

Location

Fujita Health University ( Site 1016)

Toyoake, Aichi-ken, 470-1192, Japan

Location

National Cancer Center Hospital East ( Site 1001)

Kashiwa, Chiba, 277-8577, Japan

Location

Ehime University Hospital ( Site 1014)

Tōon, Ehime, 791-0295, Japan

Location

Sapporo Medical University Hospital ( Site 1008)

Sapporo, Hokkaido, 060-8543, Japan

Location

Yokohama City University Hospital ( Site 1015)

Yokohama, Kanagawa, 236-0004, Japan

Location

Kanagawa cancer center ( Site 1021)

Yokohama, Kanagawa, 241-8515, Japan

Location

Nara Medical University Hospital ( Site 1009)

Kashihara, Nara, 634-0813, Japan

Location

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

Sayama, Osaka, 589-8511, Japan

Location

Osaka University Hospital ( Site 1006)

Suita, Osaka, 565-0871, Japan

Location

Saitama Medical University International Medical Center ( Site 1012)

Hidaka, Saitama, 350-1298, Japan

Location

Hamamatsu University Hospital ( Site 1005)

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Toyama University Hospital ( Site 1013)

Toyoma, Toyama, 930-0194, Japan

Location

Yamaguchi University Hospital ( Site 1018)

Ube, Yamaguchi, 755-8505, Japan

Location

Kyushu University Hospital ( Site 1007)

Fukuoka, 812-8582, Japan

Location

Hiroshima University Hospital-Hiroshima University Hospital ( Site 1019)

Hiroshima, 734-8551, Japan

Location

Niigata University Medical & Dental Hospital ( Site 1022)

Niigata, 951-8520, Japan

Location

Okayama University Hospital ( Site 1020)

Okayama, 700-8558, Japan

Location

Tokushima University Hospital-Department of Urology ( Site 1017)

Tokushima, 770-8503, Japan

Location

National Cancer Center Hospital ( Site 1003)

Tokyo, 104-0045, Japan

Location

Toranomon Hospital ( Site 1004)

Tokyo, 105-8470, Japan

Location

Nippon Medical School Hospital ( Site 1010)

Tokyo, 113-8603, Japan

Location

The Cancer Institute Hospital of JFCR ( Site 1000)

Tokyo, 135-8550, Japan

Location

Keio University Hospital ( Site 1002)

Tokyo, 160-8582, Japan

Location

Akershus universitetssykehus ( Site 0851)

Lorenskog, Akershus, 1478, Norway

Location

Helse Bergen HF - Haukeland Universitetssykehus ( Site 0854)

Bergen, Hordaland, 5021, Norway

Location

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1151)

Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia

Location

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

Moscow, Moscow, 105077, Russia

Location

N.N. Blokhin NMRCO ( Site 1156)

Moscow, Moscow, 115478, Russia

Location

Russian Scientific Center of Roentgenoradiology ( Site 1155)

Moscow, Moscow, 117997, Russia

Location

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

Moscow, Moscow, 119146, Russia

Location

Central Clinical Hospital with Polyclinic ( Site 1157)

Moscow, Moscow, 121359, Russia

Location

Hadassah Medical-Oncology department ( Site 1164)

Moscow, Moscow Oblast, 121205, Russia

Location

Omsk Clinical Oncology Dispensary ( Site 1150)

Omsk, Omsk Oblast, 644013, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

City clinical oncological dispensary ( Site 1154)

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

National Cancer Center ( Site 1204)

Gyeonggi-do, Kyonggi-do, 10408, South Korea

Location

Chungnam National University Hospital ( Site 1205)

Daejeon, Taejon-Kwangyokshi, 35015, South Korea

Location

Korea University Anam Hospital ( Site 1203)

Seoul, 02841, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 1202)

Seoul, 03722, South Korea

Location

Asan Medical Center ( Site 1200)

Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 1201)

Seoul, 06351, South Korea

Location

Instituto Catalan de Oncologia - ICO ( Site 1251)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitari Vall d Hebron ( Site 1250)

Barcelona, Catalonia, 08035, Spain

Location

Hospital General Universitario 12 de Octubre ( Site 1252)

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Instituto Valenciano de Oncologia - IVO ( Site 1254)

Valencia, Valenciana, Comunitat, 46009, Spain

Location

Hospital Ramon y Cajal ( Site 1253)

Madrid, 28034, Spain

Location

Laenssjukhuset Ryhov ( Site 1853)

Jönköping, Jönköping County, 551 85, Sweden

Location

Malmo Universitetssjukhus ( Site 1851)

Malmo, Skåne County, 214 28, Sweden

Location

Karolinska Universitetssjukhuset Solna ( Site 1850)

Stockholm, Stockholm County, 171 76, Sweden

Location

Norrlands Universitetssjukhus ( Site 1856)

Umeå, Västerbotten County, 901 85, Sweden

Location

Chang Gung Medical Foundation - Kaohsiung ( Site 1104)

Kaohsiung City, 83301, Taiwan

Location

Taichung Veterans General Hospital ( Site 1105)

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital ( Site 1103)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 1100)

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital ( Site 1101)

Taipei, 11217, Taiwan

Location

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

Taoyuan District, 333, Taiwan

Location

Ankara Universitesi Tip Fakultesi ( Site 1311)

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi ( Site 1300)

Ankara, 06230, Turkey (Türkiye)

Location

Gazi Universitesi Tip Fakultesi ( Site 1308)

Ankara, 06560, Turkey (Türkiye)

Location

Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1302)

Edirne, 22030, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1305)

Istanbul, 34098, Turkey (Türkiye)

Location

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

Istanbul, 34722, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi ( Site 1304)

Izmir, 35100, Turkey (Türkiye)

Location

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

Izmir, 35360, Turkey (Türkiye)

Location

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

Dnipropetrovsk, Dnipropetrovsk Oblast, 49005, Ukraine

Location

MI Precarpathian Clinical Oncology Center ( Site 1452)

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

Location

Kyiv City Clinical Oncology Center ( Site 1450)

Kyiv, Kyivska Oblast, 03115, Ukraine

Location

Cambridge University Hospitals NHSFT ( Site 1405)

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Western General Hospital ( Site 1400)

Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

Location

The Beatson West of Scotland Cancer Centre ( Site 1402)

Glasgow, Glasgow City, G12 0YN, United Kingdom

Location

Barts Health NHS Trust ( Site 1407)

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

Location

Royal Marsden NHS Foundation Trust ( Site 1403)

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

Location

Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1409)

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

Location

Royal Marsden Hospital Sutton-Surrey ( Site 1411)

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Medway Maritime Hospital ( Site 1406)

Gillingham, ME7 5NY, United Kingdom

Location

The Christie NHS Foundation Trust ( Site 1401)

Manchester, M20 4BX, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39167807 RESULT

• 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.

  PMID: 40112850 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

belzutifan; Everolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: February 27, 2020
• Primary Completion: April 15, 2024
• Study Completion (Estimated): September 17, 2026
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

UA (3); HK (4); DE (8); JP (23); CZ (6); BR (5); US (29); IT (10); CA (6); NO (2); KR (6); CO (5); TW (6); HU (6); TU (8); FI (4); FR (8); CL (2); RU (11); GB (9); DK (2); ES (5); SE (4)