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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

Primary Purpose

Carcinoma, Renal Cell

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Belzutifan
Lenvatinib
Cabozantinib
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell

Eligibility Criteria

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

Inclusion Criteria:

  • Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
  • Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment or neoadjuvant/adjuvant with progression on or within 6 months of last dose.
  • Measurable disease per RECIST 1.1 criteria as assessed by local study investigator.
  • Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization.
  • Received no more than 2 prior systemic regimens including: one anti-PD-1/L1 containing adjuvant or neoadjuvant/adjuvant regimens with progression on or within 6 months from the last dose of that regimen OR one or 2 regimens for locoregional/advanced disease
  • Received only 1 prior antiPD-1/L1 therapy for adjuvant, neoadjuvant/adjuvant or locally advanced/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 belzutifan or lenvatinib in the belzutifan+lenvatinib arm, whichever occurs last, and 23 days after the last dose of cabozantinib.
  • A female participant is eligible to participate if they are 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 in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm.
  • Adequately controlled blood pressure.
  • Adequate organ function.

Exclusion Criteria:

  • A pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy.
  • Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Clinically significant cardiac disease within 6 months of first dose of study intervention.
  • Prolongation of QTc interval to >480 ms.
  • Symptomatic pleural effusion (e.g.,cough, dyspnea, pleuritic chest pain) that is not clinically stable.
  • Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula.
  • Moderate to severe hepatic impairment.
  • History of significant bleeding within 3 months before randomization.
  • History of solid organ transplantation.
  • Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
  • Unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
  • Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations.
  • Received colony-stimulating factors [eg, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant erythropoietin (EPO)] within 28 days before randomization.
  • Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor.
  • Prior treatment with lenvatinib.
  • Prior treatment with cabozantinib.
  • Currently participating in a study of an investigational agent or using an investigational device.
  • Active infection requiring systemic therapy.
  • History of human immunodeficiency virus (HIV) infection.
  • History of hepatitis B or known active hepatitis C infection.

Sites / Locations

  • Ironwood Cancer & Research Centers ( Site 0077)
  • Cedars Sinai Medical Center ( Site 0027)
  • UCLA Hematology/Oncology - Santa Monica ( Site 0048)
  • St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095)
  • UC Irvine Health ( Site 0029)
  • Providence Saint John's Health Center ( Site 0083)
  • Georgetown University Medical Center ( Site 0006)
  • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0003)
  • Orlando Health, Inc. ( Site 0035)
  • University Cancer & Blood Center, LLC ( Site 0057)
  • Emory University Hospital ( Site 0012)
  • Rush University Medical Center ( Site 0040)
  • Illinois Cancer Care, PC ( Site 0008)
  • Parkview Cancer Institute ( Site 0088)
  • Norton Cancer Institute - St. Matthews ( Site 0065)
  • Tulane University School of Medicine ( Site 0098)
  • Lahey Hospital & Medical Center ( Site 0090)
  • Cancer & Hematology Centers of Western Michigan ( Site 0018)
  • HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)
  • University of Mississippi Medical Ctr ( Site 0037)
  • Cancer Partners of Nebraska ( Site 0086)
  • Rutgers Cancer Institute of New Jersey ( Site 0078)
  • R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)
  • Memorial Sloan Kettering Cancer Center ( Site 0055)
  • Levine Cancer Institute ( Site 0004)
  • Duke Cancer Institute ( Site 0096)
  • Lehigh Valley Hospital- Cedar Crest-Oncology Clinical Trials ( Site 0056)
  • University of Texas, Southwestern Medical Center ( Site 0015)
  • Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 7001)
  • University of Vermont Medical Center ( Site 0001)
  • Blue Ridge Cancer Care - Roanoke ( Site 0043)
  • Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 0093)
  • Confluence Health | Wenatchee Valley Hospital & Clinics ( Site 0061)
  • Centro de Urología (CDU) ( Site 0803)
  • Hospital Británico de Buenos Aires-Oncology ( Site 0801)
  • Instituto Alexander Fleming ( Site 0800)
  • Sanatorio Británico-Clinical Oncology Department ( Site 0802)
  • Sanatorio Parque ( Site 0806)
  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 0804)
  • GenesisCare North Shore ( Site 4011)
  • Lyell McEwin Hospital ( Site 4004)
  • Peninsula Health Frankston Hospital ( Site 4001)
  • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 4010)
  • Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 1001)
  • Medizinische Universitätsklinik Graz ( Site 1051)
  • Klinik Ottakring-1.Medizinische Abteilung - Zentrum für Onkologie und Hämatologie ( Site 1031)
  • Krankenhaus der Barmherzigen Brüder Wien ( Site 1041)
  • Medizinische Universität Wien ( Site 1021)
  • Institut Jules Bordet ( Site 1103)
  • Cliniques Universitaires Saint Luc - Bruxelles ( Site 1105)
  • Grand Hopital de Charleroi ( Site 1104)
  • UZ Gent ( Site 1100)
  • UZ Leuven ( Site 1101)
  • CHU de Liege ( Site 1102)
  • Liga Norte Riograndense Contra o Cancer ( Site 0313)
  • Centro Gaucho Integrado de Oncologia ( Site 0304)
  • BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0311)
  • Hospital Paulistano - Amil Clinical Research ( Site 0308)
  • Tom Baker Cancer Centre ( Site 0109)
  • Cross Cancer Institute ( Site 0111)
  • BC Cancer Vancouver-Clinical Trials Unit ( Site 0110)
  • The Moncton Hospital ( Site 0101)
  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0114)
  • Kingston Health Sciences Centre ( Site 0105)
  • The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0116)
  • Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0113)
  • CISSS de la Monteregie-Centre ( Site 0103)
  • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0102)
  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
  • James Lind Centro de Investigación del Cáncer ( Site 0402)
  • Bradfordhill-Clinical Area ( Site 0400)
  • Fundación Colombiana de Cancerología Clínica Vida ( Site 0505)
  • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0508)
  • Instituto Nacional de Cancerología-Clinical Oncology ( Site 0500)
  • Fundación Cardiovascular de Colombia ( Site 0501)
  • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 2203)
  • Nemocnice České Budějovice-Onkologicke oddeleni ( Site 2204)
  • Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 2200)
  • Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 2205)
  • Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 2201)
  • Tampereen yliopistollinen sairaala ( Site 1801)
  • HYKS ( Site 1800)
  • TYKS ( Site 1802)
  • Institut Jean Godinot ( Site 1216)
  • Centre Antoine Lacassagne ( Site 1217)
  • Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1218)
  • CHU de Bordeaux- Hopital Saint Andre ( Site 1209)
  • Institut Claudius Regaud ( Site 1215)
  • Clinique Francois Chenieux ( Site 1210)
  • Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1201)
  • Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1200)
  • Hopital Tenon ( Site 1213)
  • Klinik fuer Urologie ( Site 1303)
  • NCT-Department of Medical Oncology ( Site 1320)
  • Klinikum Nuernberg Nord ( Site 1300)
  • Universitaetsklinikum Frankfurt ( Site 1301)
  • Universitaetsklinikum Aachen AOER ( Site 1317)
  • Universitaetsklinikum des Saarlandes ( Site 1305)
  • Krankenhaus Martha Maria Halle-Doelau ( Site 1314)
  • Helios Klinikum Erfurt GmbH ( Site 1315)
  • Charite Universitaetsmedizin Berlin ( Site 1321)
  • HELIOS Klinikum Berlin-Buch ( Site 1311)
  • UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 3302)
  • Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 3304)
  • Athens Medical Center ( Site 3303)
  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3301)
  • European Interbalkan Medical Center-Oncology Department ( Site 3300)
  • Mater Misericordiae University Hospital ( Site 3201)
  • Tallaght University Hospital ( Site 3200)
  • Mater Private Hospital - Dublin ( Site 3202)
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1407)
  • Istituto Clinico Humanitas Research Hospital ( Site 1406)
  • Ospedale San Luigi Gonzaga ( Site 1405)
  • Medical Oncology Ospedale San Donato ( Site 1404)
  • Azienda Ospedaliera Policlinico di Bari ( Site 1402)
  • IRCCS Ospedale San Raffaele ( Site 1409)
  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1400)
  • Istituti Clinici Scientifici Maugeri Spa ( Site 1403)
  • Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1410)
  • Azienda Ospedaliera S. Maria di Terni ( Site 1401)
  • Ospedale Maggiore Borgo Trento ( Site 1408)
  • Fujita Health University ( Site 5003)
  • National Cancer Center Hospital East ( Site 5000)
  • Toho University Sakura Medical Center ( Site 5014)
  • Sapporo Medical University Hospital ( Site 5008)
  • Kobe City Medical Center General Hospital ( Site 5017)
  • Yokohama City University Hospital ( Site 5007)
  • Nara Medical University Hospital ( Site 5002)
  • Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010)
  • Osaka University Hospital ( Site 5012)
  • Hamamatsu University School of Medicine University Hospital ( Site 5004)
  • Tokyo Medical and Dental University Hospital ( Site 5009)
  • Toranomon Hospital ( Site 5001)
  • Kyushu University Hospital ( Site 5005)
  • Niigata University Medical & Dental Hospital ( Site 5013)
  • Osaka International Cancer Institute ( Site 5016)
  • Nippon Medical School Hospital ( Site 5006)
  • Tokyo Women's Medical University Adachi Medical Center ( Site 5015)
  • Keio university hospital ( Site 5011)
  • Chonnam National University Hwasun Hospital-Oncology ( Site 4203)
  • Asan Medical Center ( Site 4200)
  • Samsung Medical Center ( Site 4201)
  • Medisch Centrum Leeuwarden ( Site 1905)
  • Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1904)
  • Amphia Hospital Location Molengracht ( Site 1912)
  • Antoni van Leeuwenhoek Ziekenhuis ( Site 1901)
  • Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1917)
  • Erasmus MC ( Site 1913)
  • Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1909)
  • Universitair Medisch Centrum Utrecht ( Site 1910)
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2402)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - O-Klinika Onkologii Klinicznej ( Site 240
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2400)
  • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2401)
  • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2500)
  • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2501)
  • Centrul de Oncologie "Sfântul Nectarie" ( Site 2502)
  • Ivanovo Regional Oncology Dispensary ( Site 2616)
  • MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 2618)
  • Hadassah Medical-Oncology department ( Site 2609)
  • FSBI United Hospital with Polyclinic ( Site 2613)
  • SHI of Moscow City Oncology Clinical Hospital - 62 ( Site 2614)
  • Volgograd Regional Uronephrological Center ( Site 2615)
  • Yaroslavl Regional Cancer Hospital-Oncology ( Site 2619)
  • Complejo Hospitalario Universitario A Coruna ( Site 1502)
  • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1508)
  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1507)
  • Hospital Clinic i Provincial ( Site 1500)
  • Hospital Santa Creu i Sant Pau ( Site 1501)
  • Hospital General Universitario Gregorio Maranon ( Site 1505)
  • Hospital Clinico San Carlos ( Site 1504)
  • Hospital Virgen del Rocio ( Site 1503)
  • Hopitaux Universitaires de Geneve HUG ( Site 1602)
  • Kantonsspital Graubuenden ( Site 1600)
  • Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1604)
  • Universitaetsspital Zuerich ( Site 1601)
  • Aberdeen Royal Infirmary-Department of Oncology ( Site 3105)
  • Royal United Hospital Bath England ( Site 3108)
  • Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 3106)
  • Southend University Hospital ( Site 3112)
  • Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 3107)
  • Mount Vernon Cancer Centre ( Site 3101)
  • Musgrove Park Hospital ( Site 3103)
  • Singleton Hospital ( Site 3111)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Belzutifan + Lenvatinib

Cabozantinib

Arm Description

Belzutifan 120 mg and lenvatinib 20 mg orally once a day

Cabozantinib 60 mg orally once a day

Outcomes

Primary Outcome Measures

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)
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)
OS is defined as time from randomization to death due to any cause.

Secondary Outcome Measures

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (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 Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (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 Experienced One or More Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Full Information

First Posted
October 9, 2020
Last Updated
August 11, 2023
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04586231
Brief Title
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Official Title
An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination With Lenvatinib (MK-7902) vs Cabozantinib in Participants With Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
December 23, 2024 (Anticipated)
Study Completion Date
December 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
708 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Belzutifan + Lenvatinib
Arm Type
Experimental
Arm Description
Belzutifan 120 mg and lenvatinib 20 mg orally once a day
Arm Title
Cabozantinib
Arm Type
Active Comparator
Arm Description
Cabozantinib 60 mg orally once a day
Intervention Type
Drug
Intervention Name(s)
Belzutifan
Other Intervention Name(s)
PT2977, MK-6482, WELIREG™
Intervention Description
Immediate-release 40 mg tablet
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
Lenvima, E7080, MK-7902
Intervention Description
Capsule available in 4 mg and 10 mg dosages
Intervention Type
Drug
Intervention Name(s)
Cabozantinib
Other Intervention Name(s)
Cabometyx, Cometriq, XL184, BMS-907351
Intervention Description
Tablet available in 20 mg, 40 mg and 60 mg dosages
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Up to approximately 34 months
Title
Overall Survival (OS)
Description
OS is defined as time from randomization to death due to any cause.
Time Frame
Up to approximately 44 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Description
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.
Time Frame
Up to approximately 24 months
Title
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Description
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.
Time Frame
Up to approximately 44 months
Title
Number of Participants Who Experienced One or More Adverse Events (AEs)
Description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 44 months
Title
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to approximately 44 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC). Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment or neoadjuvant/adjuvant with progression on or within 6 months of last dose. Measurable disease per RECIST 1.1 criteria as assessed by local study investigator. Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization. Received no more than 2 prior systemic regimens including: one anti-PD-1/L1 containing adjuvant or neoadjuvant/adjuvant regimens with progression on or within 6 months from the last dose of that regimen OR one or 2 regimens for locoregional/advanced disease Received only 1 prior antiPD-1/L1 therapy for adjuvant, neoadjuvant/adjuvant or locally advanced/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 belzutifan or lenvatinib in the belzutifan+lenvatinib arm, whichever occurs last, and 23 days after the last dose of cabozantinib. A female participant is eligible to participate if they are 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 in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm. Adequately controlled blood pressure. Adequate organ function. Exclusion Criteria: A pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen. Known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy. Known central nervous system (CNS) metastases and/or carcinomatous meningitis. Clinically significant cardiac disease within 6 months of first dose of study intervention. Prolongation of QTc interval to >480 ms. Symptomatic pleural effusion (e.g.,cough, dyspnea, pleuritic chest pain) that is not clinically stable. Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula. Moderate to severe hepatic impairment. History of significant bleeding within 3 months before randomization. History of solid organ transplantation. Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study. Unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption). Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations. Received colony-stimulating factors [eg, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant erythropoietin (EPO)] within 28 days before randomization. Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor. Prior treatment with lenvatinib. Prior treatment with cabozantinib. Currently participating in a study of an investigational agent or using an investigational device. Active infection requiring systemic therapy. History of human immunodeficiency virus (HIV) infection. History of hepatitis B or known active hepatitis C 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
Ironwood Cancer & Research Centers ( Site 0077)
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Cedars Sinai Medical Center ( Site 0027)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA Hematology/Oncology - Santa Monica ( Site 0048)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UC Irvine Health ( Site 0029)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Providence Saint John's Health Center ( Site 0083)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Georgetown University Medical Center ( Site 0006)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0003)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Orlando Health, Inc. ( Site 0035)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University Cancer & Blood Center, LLC ( Site 0057)
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Emory University Hospital ( Site 0012)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rush University Medical Center ( Site 0040)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Illinois Cancer Care, PC ( Site 0008)
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Parkview Cancer Institute ( Site 0088)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Norton Cancer Institute - St. Matthews ( Site 0065)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Tulane University School of Medicine ( Site 0098)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Lahey Hospital & Medical Center ( Site 0090)
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Cancer & Hematology Centers of Western Michigan ( Site 0018)
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
University of Mississippi Medical Ctr ( Site 0037)
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39213
Country
United States
Facility Name
Cancer Partners of Nebraska ( Site 0086)
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 0078)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center ( Site 0055)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute ( Site 0004)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke Cancer Institute ( Site 0096)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Lehigh Valley Hospital- Cedar Crest-Oncology Clinical Trials ( Site 0056)
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
University of Texas, Southwestern Medical Center ( Site 0015)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Facility Name
Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 7001)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Facility Name
University of Vermont Medical Center ( Site 0001)
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Blue Ridge Cancer Care - Roanoke ( Site 0043)
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 0093)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Confluence Health | Wenatchee Valley Hospital & Clinics ( Site 0061)
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Centro de Urología (CDU) ( Site 0803)
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1120AAT
Country
Argentina
Facility Name
Hospital Británico de Buenos Aires-Oncology ( Site 0801)
City
Ciudad autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Instituto Alexander Fleming ( Site 0800)
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Sanatorio Británico-Clinical Oncology Department ( Site 0802)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Sanatorio Parque ( Site 0806)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Asociación de Beneficencia Hospital Sirio Libanés ( Site 0804)
City
Buenos Aires
ZIP/Postal Code
C1419AHN
Country
Argentina
Facility Name
GenesisCare North Shore ( Site 4011)
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Lyell McEwin Hospital ( Site 4004)
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Peninsula Health Frankston Hospital ( Site 4001)
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 4010)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 1001)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universitätsklinik Graz ( Site 1051)
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Klinik Ottakring-1.Medizinische Abteilung - Zentrum für Onkologie und Hämatologie ( Site 1031)
City
Vienna
State/Province
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Krankenhaus der Barmherzigen Brüder Wien ( Site 1041)
City
Wien
ZIP/Postal Code
1020
Country
Austria
Facility Name
Medizinische Universität Wien ( Site 1021)
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Institut Jules Bordet ( Site 1103)
City
Anderlecht
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires Saint Luc - Bruxelles ( Site 1105)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hopital de Charleroi ( Site 1104)
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZ Gent ( Site 1100)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven ( Site 1101)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liege ( Site 1102)
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Liga Norte Riograndense Contra o Cancer ( Site 0313)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59151600
Country
Brazil
Facility Name
Centro Gaucho Integrado de Oncologia ( Site 0304)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90110-270
Country
Brazil
Facility Name
BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0311)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Hospital Paulistano - Amil Clinical Research ( Site 0308)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Tom Baker Cancer Centre ( Site 0109)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute ( Site 0111)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BC Cancer Vancouver-Clinical Trials Unit ( Site 0110)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
The Moncton Hospital ( Site 0101)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0114)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Kingston Health Sciences Centre ( Site 0105)
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0116)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0113)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
CISSS de la Monteregie-Centre ( Site 0103)
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0102)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
James Lind Centro de Investigación del Cáncer ( Site 0402)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile
Facility Name
Bradfordhill-Clinical Area ( Site 0400)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Fundación Colombiana de Cancerología Clínica Vida ( Site 0505)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050030
Country
Colombia
Facility Name
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0508)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Facility Name
Instituto Nacional de Cancerología-Clinical Oncology ( Site 0500)
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
111511
Country
Colombia
Facility Name
Fundación Cardiovascular de Colombia ( Site 0501)
City
Piedecuesta
State/Province
Santander
ZIP/Postal Code
681017
Country
Colombia
Facility Name
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 2203)
City
Brno
State/Province
Brno-mesto
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Nemocnice České Budějovice-Onkologicke oddeleni ( Site 2204)
City
České Budějovice
State/Province
Jihocesky Kraj
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 2200)
City
Prague
State/Province
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 2205)
City
Praha
State/Province
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 2201)
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Tampereen yliopistollinen sairaala ( Site 1801)
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
Facility Name
HYKS ( Site 1800)
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00290
Country
Finland
Facility Name
TYKS ( Site 1802)
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20520
Country
Finland
Facility Name
Institut Jean Godinot ( Site 1216)
City
Reims
State/Province
Ain
ZIP/Postal Code
51726
Country
France
Facility Name
Centre Antoine Lacassagne ( Site 1217)
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06189
Country
France
Facility Name
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1218)
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67200
Country
France
Facility Name
CHU de Bordeaux- Hopital Saint Andre ( Site 1209)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33075
Country
France
Facility Name
Institut Claudius Regaud ( Site 1215)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Clinique Francois Chenieux ( Site 1210)
City
Limoges
State/Province
Haute-Vienne
ZIP/Postal Code
87039
Country
France
Facility Name
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1201)
City
Saint Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1200)
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49055
Country
France
Facility Name
Hopital Tenon ( Site 1213)
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Klinik fuer Urologie ( Site 1303)
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
NCT-Department of Medical Oncology ( Site 1320)
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinikum Nuernberg Nord ( Site 1300)
City
Nuremberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt ( Site 1301)
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Aachen AOER ( Site 1317)
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes ( Site 1305)
City
Homburg/ Saar
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Krankenhaus Martha Maria Halle-Doelau ( Site 1314)
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Helios Klinikum Erfurt GmbH ( Site 1315)
City
Erfurt
State/Province
Thuringen
ZIP/Postal Code
99089
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin ( Site 1321)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
HELIOS Klinikum Berlin-Buch ( Site 1311)
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 3302)
City
Patras
State/Province
Achaia
ZIP/Postal Code
26504
Country
Greece
Facility Name
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 3304)
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Athens Medical Center ( Site 3303)
City
Athens
State/Province
Attiki
ZIP/Postal Code
151 25
Country
Greece
Facility Name
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3301)
City
Chaidari
State/Province
Attiki
ZIP/Postal Code
124 62
Country
Greece
Facility Name
European Interbalkan Medical Center-Oncology Department ( Site 3300)
City
Thessaloniki
ZIP/Postal Code
570 01
Country
Greece
Facility Name
Mater Misericordiae University Hospital ( Site 3201)
City
Dublin 7
State/Province
Dublin
ZIP/Postal Code
D07 R2WY
Country
Ireland
Facility Name
Tallaght University Hospital ( Site 3200)
City
Dublin
ZIP/Postal Code
D24NR0A
Country
Ireland
Facility Name
Mater Private Hospital - Dublin ( Site 3202)
City
Dublin
ZIP/Postal Code
Dublin 7
Country
Ireland
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1407)
City
Meldola
State/Province
Forli-Cesena
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Clinico Humanitas Research Hospital ( Site 1406)
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Ospedale San Luigi Gonzaga ( Site 1405)
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Medical Oncology Ospedale San Donato ( Site 1404)
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Azienda Ospedaliera Policlinico di Bari ( Site 1402)
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele ( Site 1409)
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1400)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituti Clinici Scientifici Maugeri Spa ( Site 1403)
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1410)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria di Terni ( Site 1401)
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Ospedale Maggiore Borgo Trento ( Site 1408)
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Fujita Health University ( Site 5003)
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 5000)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Toho University Sakura Medical Center ( Site 5014)
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Sapporo Medical University Hospital ( Site 5008)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Kobe City Medical Center General Hospital ( Site 5017)
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Yokohama City University Hospital ( Site 5007)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2360004
Country
Japan
Facility Name
Nara Medical University Hospital ( Site 5002)
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka University Hospital ( Site 5012)
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Hamamatsu University School of Medicine University Hospital ( Site 5004)
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital ( Site 5009)
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138519
Country
Japan
Facility Name
Toranomon Hospital ( Site 5001)
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Kyushu University Hospital ( Site 5005)
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital ( Site 5013)
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 5016)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Nippon Medical School Hospital ( Site 5006)
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Tokyo Women's Medical University Adachi Medical Center ( Site 5015)
City
Tokyo
ZIP/Postal Code
123-8558
Country
Japan
Facility Name
Keio university hospital ( Site 5011)
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital-Oncology ( Site 4203)
City
Hwasun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 4200)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 4201)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Medisch Centrum Leeuwarden ( Site 1905)
City
Leeuwarden
State/Province
Fryslan
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1904)
City
Sittard-Geleen
State/Province
Limburg
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Amphia Hospital Location Molengracht ( Site 1912)
City
Breda
State/Province
Noord-Brabant
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Antoni van Leeuwenhoek Ziekenhuis ( Site 1901)
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1917)
City
Den Haag
State/Province
Zuid-Holland
ZIP/Postal Code
2545 AA
Country
Netherlands
Facility Name
Erasmus MC ( Site 1913)
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
GD 3015
Country
Netherlands
Facility Name
Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1909)
City
Schiedam
State/Province
Zuid-Holland
ZIP/Postal Code
3118 JH
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht ( Site 1910)
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2402)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - O-Klinika Onkologii Klinicznej ( Site 240
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2400)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2401)
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2500)
City
Cluj Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2501)
City
Cluj Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Centrul de Oncologie "Sfântul Nectarie" ( Site 2502)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200542
Country
Romania
Facility Name
Ivanovo Regional Oncology Dispensary ( Site 2616)
City
Ivanovo
State/Province
Ivanovskaya Oblast
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 2618)
City
Krasnogorsk
State/Province
Moskovskaya Oblast
ZIP/Postal Code
143442
Country
Russian Federation
Facility Name
Hadassah Medical-Oncology department ( Site 2609)
City
Moscow
State/Province
Moskovskaya Oblast
ZIP/Postal Code
121205
Country
Russian Federation
Facility Name
FSBI United Hospital with Polyclinic ( Site 2613)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119285
Country
Russian Federation
Facility Name
SHI of Moscow City Oncology Clinical Hospital - 62 ( Site 2614)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125130
Country
Russian Federation
Facility Name
Volgograd Regional Uronephrological Center ( Site 2615)
City
Volzhsky
State/Province
Volgogradskaya Oblast
ZIP/Postal Code
404120
Country
Russian Federation
Facility Name
Yaroslavl Regional Cancer Hospital-Oncology ( Site 2619)
City
Yaroslavl
State/Province
Yaroslavskaya Oblast
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Complejo Hospitalario Universitario A Coruna ( Site 1502)
City
A Coruna
State/Province
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1508)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1507)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial ( Site 1500)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau ( Site 1501)
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 1505)
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Clinico San Carlos ( Site 1504)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Virgen del Rocio ( Site 1503)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hopitaux Universitaires de Geneve HUG ( Site 1602)
City
Geneva
State/Province
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Kantonsspital Graubuenden ( Site 1600)
City
Chur
State/Province
Grisons
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1604)
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Universitaetsspital Zuerich ( Site 1601)
City
Zuerich
State/Province
Zurich
ZIP/Postal Code
8001
Country
Switzerland
Facility Name
Aberdeen Royal Infirmary-Department of Oncology ( Site 3105)
City
Aberdeen
State/Province
Aberdeen City
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Royal United Hospital Bath England ( Site 3108)
City
Bath
State/Province
Bath And North East Somerset
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 3106)
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PF
Country
United Kingdom
Facility Name
Southend University Hospital ( Site 3112)
City
Southend
State/Province
Essex
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 3107)
City
London
State/Province
London, City Of
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre ( Site 3101)
City
Northwood
State/Province
London, City Of
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Musgrove Park Hospital ( Site 3103)
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Singleton Hospital ( Site 3111)
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
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
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

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