Clinical trial NCT04195750: A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
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
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-12-12
Enrollment: 755
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free Survival (PFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 39 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 49 months
Secondary outcomes:
measure: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 31 months
measure: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
timeFrame: Up to approximately 49 months
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 78 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 78 months
measure: 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
timeFrame: Up to approximately 39 months
measure: TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
timeFrame: Up to approximately 39 months
measure: TTD in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score
timeFrame: Up to approximately 39 months
measure: Change From Baseline to Week 17 in the HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Combined Score
timeFrame: Baseline (Day 1) and week 17
measure: Change From Baseline to Week 17 in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
timeFrame: Baseline (Day 1) and week 17
measure: Change From Baseline to Week 17 in Disease Symptoms Using the FKSI-DRS Items 1-9 Score
timeFrame: Baseline (Day 1) and week 17
measure: Change From Baseline to Week 17 in Visual Analogue Scale (VAS) Score on the European Quality of Life 5 Dimension, 5-level Questionnaire (EQ-5D-5L) Health Utility Score
timeFrame: Baseline (Day 1) and week 17
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham ( Site 1538)
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center ( Site 1546)
state: California
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare ( Site 1531)
state: California
city: Aurora
country: United States
facility: University Of Colorado ( Site 1540)
state: Colorado
city: Highlands Ranch
country: United States
facility: UCHealth Highlands Ranch Hospital ( Site 1560)
state: Colorado
city: Washington
country: United States
facility: Sibley Memorial Hospital ( Site 1559)
state: District of Columbia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers PC ( Site 1520)
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Medical Center ( Site 1539)
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Medical Center ( Site 1522)
state: Louisiana
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1514)
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital ( Site 1558)
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center ( Site 1501)
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute ( Site 1505)
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Cancer Center ( Site 1511)
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic ( Site 1509)
state: Mississippi
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center ( Site 1549)
state: Montana
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 1513)
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Medical Center ( Site 1543)
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill ( Site 1537)
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc. ( Site 1524)
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic ( Site 1504)
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1523)
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University ( Site 1553)
state: Oregon
city: Philadelphia
country: United States
facility: Abramson Cancer Center ( Site 1525)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center ( Site 1506)
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina ( Site 1518)
state: South Carolina
city: Nashville
country: United States
facility: Henry Joyce Cancer Clinic ( Site 1544)
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology-Austin Central ( Site 1533)
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.-Dallas ( Site 1534)
state: Texas
city: Belo Horizonte
country: Brazil
facility: Centro Avancado de Tratamento Oncologico ( Site 1657)
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1650)
state: Parana
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer ( Site 1651)
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre ( Site 1655)
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 1653)
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver Center ( Site 0155)
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority QEII-HSC ( Site 0150)
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre ( Site 0154)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0153)
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0151)
state: Quebec
city: Quebec
country: Canada
facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0152)
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 0004)
state: Araucania
city: Santiago
country: Chile
facility: Bradfordhill ( Site 0003)
state: Region M. De Santiago
city: Medellin
country: Colombia
facility: Fundacion Centro de Investigacion Clinica CIC ( Site 1703)
state: Antioquia
city: Valledupar
country: Colombia
facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1709)
state: Cesar
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1702)
state: Cundinamarca
city: Bogota
country: Colombia
facility: Administradora Country SA - Clinica del Country ( Site 1701)
state: Distrito Capital De Bogota
city: Pereira
country: Colombia
facility: Oncologos del Occidente S.A. ( Site 1708)
state: Risaralda
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav ( Site 0105)
state: Brno-mesto
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava ( Site 0103)
state: Ostrava Mesto
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove ( Site 0106)
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc ( Site 0104)
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady ( Site 0102)
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice ( Site 0107)
city: Herlev
country: Denmark
facility: Herlev Hospital ( Site 0251)
state: Hovedstaden
city: Aarhus
country: Denmark
facility: Aarhus University Hospital Skejby ( Site 0250)
state: Midtjylland
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala ( Site 0300)
state: Pirkanmaa
city: Kuopio
country: Finland
facility: Kuopion Yliopistollinen Sairaala ( Site 0304)
state: Pohjois-Savo
city: Helsinki
country: Finland
facility: HYKS. ( Site 0302)
state: Uusimaa
city: Turku
country: Finland
facility: TYKS T-sairaala Syopatautien pkl ( Site 0301)
state: Varsinais-Suomi
city: Bordeaux
country: France
facility: CHU de Bordeaux Hop St ANDRE ( Site 0359)
state: Aquitaine
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0350)
state: Bas-Rhin
city: Caen
country: France
facility: Centre Francois Baclesse ( Site 0360)
state: Calvados
city: Besancon
country: France
facility: CHU Besancon - Hopital Jean Minjoz ( Site 0351)
state: Doubs
city: Nimes
country: France
facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0352)
state: Gard
city: Vandoeuvre les Nancy
country: France
facility: Centre Alexis Vautrin Institut de Cancerologie de Lorraine ( Site 0356)
state: Meurthe-et-Moselle
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud ( Site 0354)
state: Rhone
city: Villejuif
country: France
facility: Gustave Roussy ( Site 0353)
state: Val-de-Marne
city: Tuebingen
country: Germany
facility: Universitaetsklinik fuer Urologie ( Site 0405)
state: Baden-Wurttemberg
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf ( Site 0410)
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen ( Site 0401)
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0404)
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0403)
state: Sachsen
city: Jena
country: Germany
facility: Universitaetsklinikum Jena ( Site 0402)
state: Thuringen
city: Berlin
country: Germany
facility: Universitaetsmedizin Berlin ( Site 0400)
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg-Eppendorf ( Site 0408)
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital ( Site 1050)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 1051)
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital. ( Site 1052)
city: Lai Chi Kok
country: Hong Kong
facility: Princess Margaret Hospital. ( Site 1053)
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0505)
state: Bekes
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce
state: Borsod-Abauj-Zemplen
city: Budapest
country: Hungary
facility: Semmelweis Egyetem ( Site 0501)
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 0503)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 0504)
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Korhaz ( Site 0509)
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS ( Site 0603)
state: Veneto
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 0605
state: Veneto
city: Arezzo
country: Italy
facility: Medical Oncology Ospedale San Donato ( Site 0609)
city: Bari
country: Italy
facility: Azienda Ospedaliera Policlinico di Bari ( Site 0610)
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi ( Site 0606)
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori ( Site 0601)
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0604)
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri clinica del lavoro ( Site 0600)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli ( Site 0607)
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria ( Site 0602)
city: Toyoake
country: Japan
facility: Fujita Health University ( Site 1016)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 1001)
state: Chiba
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 1014)
state: Ehime
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital ( Site 1008)
state: Hokkaido
city: Yokohama
country: Japan
facility: Yokohama City University Hospital ( Site 1015)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa cancer center ( Site 1021)
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 1009)
state: Nara
city: Osakasayama
country: Japan
facility: Kindai University Hospital- Osakasayama Campus-Urology ( Site 1011)
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 1006)
state: Osaka
city: Hidaka-city
country: Japan
facility: Saitama Medical University International Medical Center ( Site 1012)
state: Saitama
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital ( Site 1005)
state: Shizuoka
city: Toyoma
country: Japan
facility: Toyama University Hospital ( Site 1013)
state: Toyama
city: Ube
country: Japan
facility: Yamaguchi University Hospital ( Site 1018)
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 1007)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital-Hiroshima University Hospital ( Site 1019)
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital ( Site 1022)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 1020)
city: Tokushima
country: Japan
facility: Tokushima University Hospital-Department of Urology ( Site 1017)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 1003)
city: Tokyo
country: Japan
facility: Toranomon Hospital ( Site 1004)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 1010)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 1000)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 1002)
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center ( Site 1204)
state: Kyonggi-do
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital ( Site 1205)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital ( Site 1203)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 1202)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 1200)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 1201)
city: Lorenskog
country: Norway
facility: Akershus universitetssykehus ( Site 0851)
state: Akershus
city: Bergen
country: Norway
facility: Helse Bergen HF - Haukeland Universitetssykehus ( Site 0854)
state: Hordaland
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1151)
state: Krasnoyarskiy Kray
city: Moscow
country: Russian Federation
facility: Hadassah Medical-Oncology department ( Site 1164)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: SBIH City clinical hospital named after D.D. Pletniov ( Site 1160)
state: Moskva
city: Moscow
country: Russian Federation
facility: N.N. Blokhin NMRCO ( Site 1156)
state: Moskva
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Roentgenoradiology ( Site 1155)
state: Moskva
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 1163)
state: Moskva
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital with Polyclinic ( Site 1157)
state: Moskva
city: Omsk
country: Russian Federation
facility: Omsk Clinical Oncology Dispensary ( Site 1150)
state: Omskaya Oblast
city: Saint-Petersburg
country: Russian Federation
facility: SBHI SPb Clinical Research Centre of specialized types of medical care ( Site 1159)
state: Sankt-Peterburg
city: Sankt-Petersburg
country: Russian Federation
facility: City clinical oncological dispensary ( Site 1154)
state: Sankt-Peterburg
city: St. Petersburg
country: Russian Federation
facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 1153)
state: Sankt-Peterburg
city: L Hospitalet De Llobregat
country: Spain
facility: Instituto Catalan de Oncologia - ICO ( Site 1251)
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 1250)
state: Cataluna
city: Madrid
country: Spain
facility: Hospital General Universitario 12 de Octubre ( Site 1252)
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia - IVO ( Site 1254)
state: Valenciana, Comunitat
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal ( Site 1253)
city: Jönköping
country: Sweden
facility: Laenssjukhuset Ryhov ( Site 1853)
state: Jonkopings Lan
city: Malmo
country: Sweden
facility: Malmo Universitetssjukhus ( Site 1851)
state: Skane Lan
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 1850)
state: Stockholms Lan
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus ( Site 1856)
state: Vasterbottens Lan
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation - Kaohsiung ( Site 1104)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 1105)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 1103)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 1100)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 1101)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1106)
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi ( Site 1311)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi ( Site 1300)
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi ( Site 1308)
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1302)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1305)
city: Istanbul
country: Turkey
facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1303)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1304)
city: Izmir
country: Turkey
facility: Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 1306)
city: Dnipropetrovsk
country: Ukraine
facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 1453)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: MI Precarpathian Clinical Oncology Center ( Site 1452)
state: Ivano-Frankivska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Center ( Site 1450)
state: Kyivska Oblast
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHSFT ( Site 1405)
state: Cambridgeshire
city: Edinburgh
country: United Kingdom
facility: Western General Hospital ( Site 1400)
state: Edinburgh, City Of
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre ( Site 1402)
state: Glasgow City
city: London
country: United Kingdom
facility: Barts Health NHS Trust ( Site 1407)
state: London, City Of
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust ( Site 1403)
state: London, City Of
city: London
country: United Kingdom
facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1409)
state: London, City Of
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital Sutton-Surrey ( Site 1411)
state: Surrey
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital ( Site 1406)
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 1401)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.