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

Primary Purpose

Carcinoma, Renal Cell

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Belzutifan

Everolimus

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Alabama - Birmingham ( Site 1538)
University of California San Diego Moores Cancer Center ( Site 1546)
St Joseph Heritage Healthcare ( Site 1531)
University Of Colorado ( Site 1540)
UCHealth Highlands Ranch Hospital ( Site 1560)
Sibley Memorial Hospital ( Site 1559)
Northwest Georgia Oncology Centers PC ( Site 1520)
The University of Chicago Medical Center ( Site 1539)
Ochsner Medical Center ( Site 1522)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1514)
Massachusetts General Hospital ( Site 1558)
Beth Israel Deaconess Medical Center ( Site 1501)
Dana Farber Cancer Institute ( Site 1505)
Henry Ford Cancer Center ( Site 1511)
Hattiesburg Clinic ( Site 1509)
St. Vincent Frontier Cancer Center ( Site 1549)
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1513)
University of Rochester Medical Center ( Site 1543)
University of North Carolina at Chapel Hill ( Site 1537)
Oncology Hematology Care, Inc. ( Site 1524)
Cleveland Clinic ( Site 1504)
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1523)
Oregon Health & Science University ( Site 1553)
Abramson Cancer Center ( Site 1525)
Fox Chase Cancer Center ( Site 1506)
Medical University of South Carolina ( Site 1518)
Henry Joyce Cancer Clinic ( Site 1544)
Texas Oncology-Austin Central ( Site 1533)
Texas Oncology, P.A.-Dallas ( Site 1534)
Centro Avancado de Tratamento Oncologico ( Site 1657)
Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1650)
Liga Norte Riograndense Contra o Cancer ( Site 1651)
Hospital de Clinicas de Porto Alegre ( Site 1655)
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 1653)
BC Cancer - Vancouver Center ( Site 0155)
Nova Scotia Health Authority QEII-HSC ( Site 0150)
Juravinski Cancer Centre ( Site 0154)
Sunnybrook Research Institute ( Site 0153)
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0151)
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0152)
Centro Investigación del Cáncer James Lind ( Site 0004)
Bradfordhill ( Site 0003)
Fundacion Centro de Investigacion Clinica CIC ( Site 1703)
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1709)
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1702)
Administradora Country SA - Clinica del Country ( Site 1701)
Oncologos del Occidente S.A. ( Site 1708)
Masarykuv onkologicky ustav ( Site 0105)
Fakultni nemocnice Ostrava ( Site 0103)
Fakultni nemocnice Hradec Kralove ( Site 0106)
Fakultni nemocnice Olomouc ( Site 0104)
Fakultni nemocnice Kralovske Vinohrady ( Site 0102)
Fakultni Thomayerova nemocnice ( Site 0107)
Herlev Hospital ( Site 0251)
Aarhus University Hospital Skejby ( Site 0250)
Tampereen yliopistollinen sairaala ( Site 0300)
Kuopion Yliopistollinen Sairaala ( Site 0304)
HYKS. ( Site 0302)
TYKS T-sairaala Syopatautien pkl ( Site 0301)
CHU de Bordeaux Hop St ANDRE ( Site 0359)
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0350)
Centre Francois Baclesse ( Site 0360)
CHU Besancon - Hopital Jean Minjoz ( Site 0351)
Institut de Cancerologie du Gard - CHU Caremeau ( Site 0352)
Centre Alexis Vautrin Institut de Cancerologie de Lorraine ( Site 0356)
Centre Hospitalier Lyon Sud ( Site 0354)
Gustave Roussy ( Site 0353)
Universitaetsklinik fuer Urologie ( Site 0405)
Universitaetsklinikum Duesseldorf ( Site 0410)
Universitaetsklinikum Essen ( Site 0401)
Universitaetsklinikum Magdeburg A.o.R. ( Site 0404)
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0403)
Universitaetsklinikum Jena ( Site 0402)
Universitaetsmedizin Berlin ( Site 0400)
Universitatsklinikum Hamburg-Eppendorf ( Site 0408)
Prince of Wales Hospital ( Site 1050)
Queen Mary Hospital ( Site 1051)
Queen Elizabeth Hospital. ( Site 1052)
Princess Margaret Hospital. ( Site 1053)
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0505)
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce
Semmelweis Egyetem ( Site 0501)
Orszagos Onkologiai Intezet ( Site 0503)
Debreceni Egyetem Klinikai Kozpont ( Site 0504)
Zala Megyei Szent Rafael Korhaz ( Site 0509)
Istituto Oncologico Veneto IRCCS ( Site 0603)
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 0605
Medical Oncology Ospedale San Donato ( Site 0609)
Azienda Ospedaliera Policlinico di Bari ( Site 0610)
Policlinico S. Orsola-Malpighi ( Site 0606)
Istituto Nazionale dei Tumori ( Site 0601)
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0604)
Fondazione Salvatore Maugeri clinica del lavoro ( Site 0600)
Fondazione Policlinico Universitario A. Gemelli ( Site 0607)
Azienda Ospedaliera Santa Maria ( Site 0602)
Fujita Health University ( Site 1016)
National Cancer Center Hospital East ( Site 1001)
Ehime University Hospital ( Site 1014)
Sapporo Medical University Hospital ( Site 1008)
Yokohama City University Hospital ( Site 1015)
Kanagawa cancer center ( Site 1021)
Nara Medical University Hospital ( Site 1009)
Kindai University Hospital- Osakasayama Campus-Urology ( Site 1011)
Osaka University Hospital ( Site 1006)
Saitama Medical University International Medical Center ( Site 1012)
Hamamatsu University Hospital ( Site 1005)
Toyama University Hospital ( Site 1013)
Yamaguchi University Hospital ( Site 1018)
Kyushu University Hospital ( Site 1007)
Hiroshima University Hospital-Hiroshima University Hospital ( Site 1019)
Niigata University Medical & Dental Hospital ( Site 1022)
Okayama University Hospital ( Site 1020)
Tokushima University Hospital-Department of Urology ( Site 1017)
National Cancer Center Hospital ( Site 1003)
Toranomon Hospital ( Site 1004)
Nippon Medical School Hospital ( Site 1010)
The Cancer Institute Hospital of JFCR ( Site 1000)
Keio University Hospital ( Site 1002)
National Cancer Center ( Site 1204)
Chungnam National University Hospital ( Site 1205)
Korea University Anam Hospital ( Site 1203)
Severance Hospital Yonsei University Health System ( Site 1202)
Asan Medical Center ( Site 1200)
Samsung Medical Center ( Site 1201)
Akershus universitetssykehus ( Site 0851)
Helse Bergen HF - Haukeland Universitetssykehus ( Site 0854)
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1151)
Hadassah Medical-Oncology department ( Site 1164)
SBIH City clinical hospital named after D.D. Pletniov ( Site 1160)
N.N. Blokhin NMRCO ( Site 1156)
Russian Scientific Center of Roentgenoradiology ( Site 1155)
First Moscow State Medical University n.a. I.M.Sechenov ( Site 1163)
Central Clinical Hospital with Polyclinic ( Site 1157)
Omsk Clinical Oncology Dispensary ( Site 1150)
SBHI SPb Clinical Research Centre of specialized types of medical care ( Site 1159)
City clinical oncological dispensary ( Site 1154)
Russian Scientific Center of Radiology and Surgical Technologies ( Site 1153)
Instituto Catalan de Oncologia - ICO ( Site 1251)
Hospital Universitari Vall d Hebron ( Site 1250)
Hospital General Universitario 12 de Octubre ( Site 1252)
Instituto Valenciano de Oncologia - IVO ( Site 1254)
Hospital Ramon y Cajal ( Site 1253)
Laenssjukhuset Ryhov ( Site 1853)
Malmo Universitetssjukhus ( Site 1851)
Karolinska Universitetssjukhuset Solna ( Site 1850)
Norrlands Universitetssjukhus ( Site 1856)
Chang Gung Medical Foundation - Kaohsiung ( Site 1104)
Taichung Veterans General Hospital ( Site 1105)
National Cheng Kung University Hospital ( Site 1103)
National Taiwan University Hospital ( Site 1100)
Taipei Veterans General Hospital ( Site 1101)
Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1106)
Ankara Universitesi Tip Fakultesi ( Site 1311)
Hacettepe Universitesi Tip Fakultesi ( Site 1300)
Gazi Universitesi Tip Fakultesi ( Site 1308)
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1302)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1305)
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1303)
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1304)
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 1306)
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 1453)
MI Precarpathian Clinical Oncology Center ( Site 1452)
Kyiv City Clinical Oncology Center ( Site 1450)
Cambridge University Hospitals NHSFT ( Site 1405)
Western General Hospital ( Site 1400)
The Beatson West of Scotland Cancer Centre ( Site 1402)
Barts Health NHS Trust ( Site 1407)
Royal Marsden NHS Foundation Trust ( Site 1403)
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1409)
Royal Marsden Hospital Sutton-Surrey ( Site 1411)
Medway Maritime Hospital ( Site 1406)
The Christie NHS Foundation Trust ( Site 1401)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Belzutifan

Everolimus

Arm Description

Participants receive 120 mg of belzutifan orally once daily (QD)

Participants receive 10 mg of Everolimus orally once daily (QD)

Outcomes

Primary Outcome Measures

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 will be presented

Overall Survival (OS)

Time from randomization to death due to any cause

Secondary Outcome Measures

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

ORR is defined as the percentage of participants who have a complete response (CR: Disappearance of all target lesions) or a partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.

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

For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR as assessed by blinded independent central review will be presented.

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

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.

Number of Participants Who Discontinue Study Treatment Due to an AE

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. The number of participants who discontinue study treatment due to an AE will be presented.

Time to 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 Score

TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in global health status (Item 29) & quality of life (Item 30) combined score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in global health status and quality of life combined score, will be presented. A longer TTD indicates a better outcome.

TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score

TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in physical functioning score, will be presented.

TTD in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score

The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer over the previous 7 days. Responses are scored on a 5-point scale (0=Not at all to 4=Very much) and summed to generate an index symptom score. These scores can range from 0 to 36, with a higher score indicating more favorable kidney cancer symptom status.

Change From Baseline in HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Score

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses for global health status (Item 29) & quality of life (Item 30) are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.

Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.

Change From Baseline in Disease Symptoms Using the FKSI-DRS Items 1-9 Score

Change from Baseline in European Quality of Life 5 Dimensions, 5-level Questionnaire (EuroQoL EQ-5D-5L) Health Utility Score

The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/ depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty, which are coded on a scale from 1 (no problems) to 5 (extreme problems). The participant is also asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale from 0 to 100, with 0 being the worst imaginable health state.

Full Information

NCT ID

NCT04195750

First Posted

December 10, 2019

Last Updated

July 28, 2022

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT04195750

Brief Title

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

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 27, 2020 (Actual)

Primary Completion Date

September 17, 2025 (Anticipated)

Study Completion Date

September 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

736 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Belzutifan

Arm Type

Experimental

Arm Description

Participants receive 120 mg of belzutifan orally once daily (QD)

Arm Title

Everolimus

Arm Type

Active Comparator

Arm Description

Participants receive 10 mg of Everolimus orally once daily (QD)

Intervention Type

Drug

Intervention Name(s)

Belzutifan

Other Intervention Name(s)

MK-6482, WELIREG™

Intervention Description

Oral tablets

Intervention Type

Drug

Intervention Name(s)

Everolimus

Other Intervention Name(s)

Afinitor, Afinitor DISPERZ, Zortress

Intervention Description

Oral tablets

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to approximately 39 months

Title

Overall Survival (OS)

Description

Time from randomization to death due to any cause

Time Frame

Up to approximately 49 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Up to approximately 39 months

Title

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

Description

Time Frame

Up to approximately 39 months

Title

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

Description

Time Frame

Up to approximately 49 months

Title

Number of Participants Who Discontinue Study Treatment Due to an AE

Description

Time Frame

Up to approximately 49 months

Title

Description

Time Frame

Up to approximately 49 months

Title

TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score

Description

Time Frame

Up to approximately 49 months

Title

TTD in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score

Description

Time Frame

Up to approximately 49 months

Title

Change From Baseline in HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Score

Description

Time Frame

Baseline (Day 1) and up to approximately 49 months

Title

Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score

Description

Time Frame

Baseline (Day 1) and up to approximately 49 months

Title

Change From Baseline in Disease Symptoms Using the FKSI-DRS Items 1-9 Score

Description

Time Frame

Baseline (Day 1) and up to approximately 49 months

Title

Change from Baseline in European Quality of Life 5 Dimensions, 5-level Questionnaire (EuroQoL EQ-5D-5L) Health Utility Score

Description

Time Frame

Baseline (Day 1) and up to approximately 49 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama - Birmingham ( Site 1538)

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

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

City

La Jolla

State/Province

California

ZIP/Postal Code

92093-0698

Country

United States

Facility Name

St Joseph Heritage Healthcare ( Site 1531)

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95403

Country

United States

Facility Name

University Of Colorado ( Site 1540)

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

UCHealth Highlands Ranch Hospital ( Site 1560)

City

Highlands Ranch

State/Province

Colorado

ZIP/Postal Code

80129

Country

United States

Facility Name

Sibley Memorial Hospital ( Site 1559)

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

Facility Name

Northwest Georgia Oncology Centers PC ( Site 1520)

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

The University of Chicago Medical Center ( Site 1539)

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Ochsner Medical Center ( Site 1522)

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Facility Name

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

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

Massachusetts General Hospital ( Site 1558)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Beth Israel Deaconess Medical Center ( Site 1501)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Dana Farber Cancer Institute ( Site 1505)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Henry Ford Cancer Center ( Site 1511)

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Hattiesburg Clinic ( Site 1509)

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39401

Country

United States

Facility Name

St. Vincent Frontier Cancer Center ( Site 1549)

City

Billings

State/Province

Montana

ZIP/Postal Code

59102

Country

United States

Facility Name

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

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

University of Rochester Medical Center ( Site 1543)

City

Rochester

State/Province

New York

ZIP/Postal Code

14620

Country

United States

Facility Name

University of North Carolina at Chapel Hill ( Site 1537)

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

Oncology Hematology Care, Inc. ( Site 1524)

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Cleveland Clinic ( Site 1504)

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

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

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74146

Country

United States

Facility Name

Oregon Health & Science University ( Site 1553)

City

Portland

State/Province

Oregon

ZIP/Postal Code

97232

Country

United States

Facility Name

Abramson Cancer Center ( Site 1525)

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Fox Chase Cancer Center ( Site 1506)

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

Medical University of South Carolina ( Site 1518)

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Henry Joyce Cancer Clinic ( Site 1544)

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Texas Oncology-Austin Central ( Site 1533)

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

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

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Centro Avancado de Tratamento Oncologico ( Site 1657)

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130-090

Country

Brazil

Facility Name

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

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80510-130

Country

Brazil

Facility Name

Liga Norte Riograndense Contra o Cancer ( Site 1651)

City

Natal

State/Province

Rio Grande Do Norte

ZIP/Postal Code

59075-740

Country

Brazil

Facility Name

Hospital de Clinicas de Porto Alegre ( Site 1655)

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 1653)

City

Sao Paulo

ZIP/Postal Code

01321-030

Country

Brazil

Facility Name

BC Cancer - Vancouver Center ( Site 0155)

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

Nova Scotia Health Authority QEII-HSC ( Site 0150)

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Juravinski Cancer Centre ( Site 0154)

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

Sunnybrook Research Institute ( Site 0153)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

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

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 3E4

Country

Canada

Facility Name

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

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Centro Investigación del Cáncer James Lind ( Site 0004)

City

Temuco

State/Province

Araucania

ZIP/Postal Code

Temuco

Country

Chile

Facility Name

Bradfordhill ( Site 0003)

City

Santiago

State/Province

Region M. De Santiago

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Fundacion Centro de Investigacion Clinica CIC ( Site 1703)

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050021

Country

Colombia

Facility Name

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

City

Valledupar

State/Province

Cesar

ZIP/Postal Code

200001

Country

Colombia

Facility Name

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

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

111321

Country

Colombia

Facility Name

Administradora Country SA - Clinica del Country ( Site 1701)

City

Bogota

State/Province

Distrito Capital De Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Oncologos del Occidente S.A. ( Site 1708)

City

Pereira

State/Province

Risaralda

ZIP/Postal Code

660001

Country

Colombia

Facility Name

Masarykuv onkologicky ustav ( Site 0105)

City

Brno

State/Province

Brno-mesto

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Fakultni nemocnice Ostrava ( Site 0103)

City

Ostrava

State/Province

Ostrava Mesto

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Fakultni nemocnice Hradec Kralove ( Site 0106)

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Fakultni nemocnice Olomouc ( Site 0104)

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Fakultni nemocnice Kralovske Vinohrady ( Site 0102)

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Fakultni Thomayerova nemocnice ( Site 0107)

City

Praha 4

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

Herlev Hospital ( Site 0251)

City

Herlev

State/Province

Hovedstaden

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Aarhus University Hospital Skejby ( Site 0250)

City

Aarhus

State/Province

Midtjylland

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Tampereen yliopistollinen sairaala ( Site 0300)

City

Tampere

State/Province

Pirkanmaa

ZIP/Postal Code

33520

Country

Finland

Facility Name

Kuopion Yliopistollinen Sairaala ( Site 0304)

City

Kuopio

State/Province

Pohjois-Savo

ZIP/Postal Code

70210

Country

Finland

Facility Name

HYKS. ( Site 0302)

City

Helsinki

State/Province

Uusimaa

ZIP/Postal Code

00290

Country

Finland

Facility Name

TYKS T-sairaala Syopatautien pkl ( Site 0301)

City

Turku

State/Province

Varsinais-Suomi

ZIP/Postal Code

20521

Country

Finland

Facility Name

CHU de Bordeaux Hop St ANDRE ( Site 0359)

City

Bordeaux

State/Province

Aquitaine

ZIP/Postal Code

33075

Country

France

Facility Name

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

City

Strasbourg

State/Province

Bas-Rhin

ZIP/Postal Code

67200

Country

France

Facility Name

Centre Francois Baclesse ( Site 0360)

City

Caen

State/Province

Calvados

ZIP/Postal Code

14076

Country

France

Facility Name

CHU Besancon - Hopital Jean Minjoz ( Site 0351)

City

Besancon

State/Province

Doubs

ZIP/Postal Code

25000

Country

France

Facility Name

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

City

Nimes

State/Province

Gard

ZIP/Postal Code

30029

Country

France

Facility Name

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

City

Vandoeuvre les Nancy

State/Province

Meurthe-et-Moselle

ZIP/Postal Code

54519

Country

France

Facility Name

Centre Hospitalier Lyon Sud ( Site 0354)

City

Pierre Benite

State/Province

Rhone

ZIP/Postal Code

69310

Country

France

Facility Name

Gustave Roussy ( Site 0353)

City

Villejuif

State/Province

Val-de-Marne

ZIP/Postal Code

94800

Country

France

Facility Name

Universitaetsklinik fuer Urologie ( Site 0405)

City

Tuebingen

State/Province

Baden-Wurttemberg

ZIP/Postal Code

72076

Country

Germany

Facility Name

Universitaetsklinikum Duesseldorf ( Site 0410)

City

Duesseldorf

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

40225

Country

Germany

Facility Name

Universitaetsklinikum Essen ( Site 0401)

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45122

Country

Germany

Facility Name

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

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39120

Country

Germany

Facility Name

Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0403)

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universitaetsklinikum Jena ( Site 0402)

City

Jena

State/Province

Thuringen

ZIP/Postal Code

07747

Country

Germany

Facility Name

Universitaetsmedizin Berlin ( Site 0400)

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Universitatsklinikum Hamburg-Eppendorf ( Site 0408)

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Prince of Wales Hospital ( Site 1050)

City

Hong Kong

Country

Hong Kong

Facility Name

Queen Mary Hospital ( Site 1051)

City

Hong Kong

Country

Hong Kong

Facility Name

Queen Elizabeth Hospital. ( Site 1052)

City

Kowloon

Country

Hong Kong

Facility Name

Princess Margaret Hospital. ( Site 1053)

City

Lai Chi Kok

Country

Hong Kong

Facility Name

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

City

Gyula

State/Province

Bekes

ZIP/Postal Code

H-5700

Country

Hungary

Facility Name

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

City

Miskolc

State/Province

Borsod-Abauj-Zemplen

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Semmelweis Egyetem ( Site 0501)

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Orszagos Onkologiai Intezet ( Site 0503)

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont ( Site 0504)

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Zala Megyei Szent Rafael Korhaz ( Site 0509)

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Istituto Oncologico Veneto IRCCS ( Site 0603)

City

Padova

State/Province

Veneto

ZIP/Postal Code

35128

Country

Italy

Facility Name

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

City

Verona

State/Province

Veneto

ZIP/Postal Code

37126

Country

Italy

Facility Name

Medical Oncology Ospedale San Donato ( Site 0609)

City

Arezzo

ZIP/Postal Code

52100

Country

Italy

Facility Name

Azienda Ospedaliera Policlinico di Bari ( Site 0610)

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Policlinico S. Orsola-Malpighi ( Site 0606)

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Istituto Nazionale dei Tumori ( Site 0601)

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0604)

City

Modena

ZIP/Postal Code

41125

Country

Italy

Facility Name

Fondazione Salvatore Maugeri clinica del lavoro ( Site 0600)

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Fondazione Policlinico Universitario A. Gemelli ( Site 0607)

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Azienda Ospedaliera Santa Maria ( Site 0602)

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

Fujita Health University ( Site 1016)

City

Toyoake

State/Province

Aichi

ZIP/Postal Code

470-1192

Country

Japan

Facility Name

National Cancer Center Hospital East ( Site 1001)

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Ehime University Hospital ( Site 1014)

City

Toon

State/Province

Ehime

ZIP/Postal Code

791-0295

Country

Japan

Facility Name

Sapporo Medical University Hospital ( Site 1008)

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8543

Country

Japan

Facility Name

Yokohama City University Hospital ( Site 1015)

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

236-0004

Country

Japan

Facility Name

Kanagawa cancer center ( Site 1021)

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

241-8515

Country

Japan

Facility Name

Nara Medical University Hospital ( Site 1009)

City

Kashihara

State/Province

Nara

ZIP/Postal Code

634-0813

Country

Japan

Facility Name

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

City

Osakasayama

State/Province

Osaka

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Osaka University Hospital ( Site 1006)

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Saitama Medical University International Medical Center ( Site 1012)

City

Hidaka-city

State/Province

Saitama

ZIP/Postal Code

350-1298

Country

Japan

Facility Name

Hamamatsu University Hospital ( Site 1005)

City

Hamamatsu

State/Province

Shizuoka

ZIP/Postal Code

431-3192

Country

Japan

Facility Name

Toyama University Hospital ( Site 1013)

City

Toyoma

State/Province

Toyama

ZIP/Postal Code

930-0194

Country

Japan

Facility Name

Yamaguchi University Hospital ( Site 1018)

City

Ube

State/Province

Yamaguchi

ZIP/Postal Code

755-8505

Country

Japan

Facility Name

Kyushu University Hospital ( Site 1007)

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Hiroshima University Hospital-Hiroshima University Hospital ( Site 1019)

City

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

Niigata University Medical & Dental Hospital ( Site 1022)

City

Niigata

ZIP/Postal Code

951-8520

Country

Japan

Facility Name

Okayama University Hospital ( Site 1020)

City

Okayama

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

Tokushima University Hospital-Department of Urology ( Site 1017)

City

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

Facility Name

National Cancer Center Hospital ( Site 1003)

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Toranomon Hospital ( Site 1004)

City

Tokyo

ZIP/Postal Code

105-8470

Country

Japan

Facility Name

Nippon Medical School Hospital ( Site 1010)

City

Tokyo

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

The Cancer Institute Hospital of JFCR ( Site 1000)

City

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Keio University Hospital ( Site 1002)

City

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

National Cancer Center ( Site 1204)

City

Gyeonggi-do

State/Province

Kyonggi-do

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Chungnam National University Hospital ( Site 1205)

City

Daejeon

State/Province

Taejon-Kwangyokshi

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

Korea University Anam Hospital ( Site 1203)

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Severance Hospital Yonsei University Health System ( Site 1202)

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Asan Medical Center ( Site 1200)

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Samsung Medical Center ( Site 1201)

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Akershus universitetssykehus ( Site 0851)

City

Lorenskog

State/Province

Akershus

ZIP/Postal Code

1478

Country

Norway

Facility Name

Helse Bergen HF - Haukeland Universitetssykehus ( Site 0854)

City

Bergen

State/Province

Hordaland

ZIP/Postal Code

5021

Country

Norway

Facility Name

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1151)

City

Krasnoyarsk

State/Province

Krasnoyarskiy Kray

ZIP/Postal Code

660133

Country

Russian Federation

Facility Name

Hadassah Medical-Oncology department ( Site 1164)

City

Moscow

State/Province

Moskovskaya Oblast

ZIP/Postal Code

121205

Country

Russian Federation

Facility Name

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

City

Moscow

State/Province

Moskva

ZIP/Postal Code

105077

Country

Russian Federation

Facility Name

N.N. Blokhin NMRCO ( Site 1156)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Russian Scientific Center of Roentgenoradiology ( Site 1155)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

117997

Country

Russian Federation

Facility Name

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

City

Moscow

State/Province

Moskva

ZIP/Postal Code

119146

Country

Russian Federation

Facility Name

Central Clinical Hospital with Polyclinic ( Site 1157)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

121359

Country

Russian Federation

Facility Name

Omsk Clinical Oncology Dispensary ( Site 1150)

City

Omsk

State/Province

Omskaya Oblast

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

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

City

Saint-Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

City clinical oncological dispensary ( Site 1154)

City

Sankt-Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

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

City

St. Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Instituto Catalan de Oncologia - ICO ( Site 1251)

City

L Hospitalet De Llobregat

State/Province

Barcelona

ZIP/Postal Code

08908

Country

Spain

Facility Name

Hospital Universitari Vall d Hebron ( Site 1250)

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital General Universitario 12 de Octubre ( Site 1252)

City

Madrid

State/Province

Madrid, Comunidad De

ZIP/Postal Code

28041

Country

Spain

Facility Name

Instituto Valenciano de Oncologia - IVO ( Site 1254)

City

Valencia

State/Province

Valenciana, Comunitat

ZIP/Postal Code

46009

Country

Spain

Facility Name

Hospital Ramon y Cajal ( Site 1253)

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Laenssjukhuset Ryhov ( Site 1853)

City

Jönköping

State/Province

Jonkopings Lan

ZIP/Postal Code

551 85

Country

Sweden

Facility Name

Malmo Universitetssjukhus ( Site 1851)

City

Malmo

State/Province

Skane Lan

ZIP/Postal Code

214 28

Country

Sweden

Facility Name

Karolinska Universitetssjukhuset Solna ( Site 1850)

City

Stockholm

State/Province

Stockholms Lan

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Norrlands Universitetssjukhus ( Site 1856)

City

Umeå

State/Province

Vasterbottens Lan

ZIP/Postal Code

901 85

Country

Sweden

Facility Name

Chang Gung Medical Foundation - Kaohsiung ( Site 1104)

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Taichung Veterans General Hospital ( Site 1105)

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

National Cheng Kung University Hospital ( Site 1103)

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

National Taiwan University Hospital ( Site 1100)

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Taipei Veterans General Hospital ( Site 1101)

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

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

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Ankara Universitesi Tip Fakultesi ( Site 1311)

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Hacettepe Universitesi Tip Fakultesi ( Site 1300)

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Gazi Universitesi Tip Fakultesi ( Site 1308)

City

Ankara

ZIP/Postal Code

06560

Country

Turkey

Facility Name

Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1302)

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1305)

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

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

City

Istanbul

ZIP/Postal Code

34722

Country

Turkey

Facility Name

Ege Universitesi Tip Fakultesi Hastanesi ( Site 1304)

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

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

City

Izmir

ZIP/Postal Code

35360

Country

Turkey

Facility Name

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

City

Dnipropetrovsk

State/Province

Dnipropetrovska Oblast

ZIP/Postal Code

49005

Country

Ukraine

Facility Name

MI Precarpathian Clinical Oncology Center ( Site 1452)

City

Ivano-Frankivsk

State/Province

Ivano-Frankivska Oblast

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Kyiv City Clinical Oncology Center ( Site 1450)

City

Kyiv

State/Province

Kyivska Oblast

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

Cambridge University Hospitals NHSFT ( Site 1405)

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Western General Hospital ( Site 1400)

City

Edinburgh

State/Province

Edinburgh, City Of

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

The Beatson West of Scotland Cancer Centre ( Site 1402)

City

Glasgow

State/Province

Glasgow City

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Barts Health NHS Trust ( Site 1407)

City

London

State/Province

London, City Of

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Royal Marsden NHS Foundation Trust ( Site 1403)

City

London

State/Province

London, City Of

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1409)

City

London

State/Province

London, City Of

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Royal Marsden Hospital Sutton-Surrey ( Site 1411)

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Medway Maritime Hospital ( Site 1406)

City

Gillingham

ZIP/Postal Code

ME7 5NY

Country

United Kingdom

Facility Name

The Christie NHS Foundation Trust ( Site 1401)

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Links:

URL

http://merckoncologyclinicaltrials.com

Description

Merck Oncology Clinical Trials Information

Learn more about this trial

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

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