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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04586231
Registration number
NCT04586231
Ethics application status
Date submitted
9/10/2020
Date registered
14/10/2020
Titles & IDs
Public title
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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Scientific 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
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Secondary ID [1]
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MK-6482-011
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Secondary ID [2]
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6482-011
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell
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Condition category
Condition code
Cancer
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0
0
0
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Non melanoma skin cancer
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Cancer
0
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0
0
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Belzutifan
Treatment: Drugs - Lenvatinib
Treatment: Drugs - Cabozantinib
Experimental: Belzutifan + Lenvatinib - Belzutifan 120 mg and lenvatinib 20 mg orally once a day
Active comparator: Cabozantinib - Cabozantinib 60 mg orally once a day
Treatment: Drugs: Belzutifan
Immediate-release 40 mg tablet
Treatment: Drugs: Lenvatinib
Capsule available in 4 mg and 10 mg dosages
Treatment: Drugs: Cabozantinib
Tablet available in 20 mg, 40 mg and 60 mg dosages
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 34 months
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as time from randomization to death due to any cause.
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Timepoint [2]
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Up to approximately 44 months
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Secondary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 24 months
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Secondary outcome [2]
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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)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 44 months
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Secondary outcome [3]
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Number of Participants Who Experienced One or More Adverse Events (AEs)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 44 months
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Secondary outcome [4]
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Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 44 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)-2a 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/02/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
11/02/2026
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Actual
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Sample size
Target
708
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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GenesisCare North Shore ( Site 4011) - St Leonards
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Lyell McEwin Hospital ( Site 4004) - Elizabeth Vale
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Peninsula Health Frankston Hospital ( Site 4001) - Frankston
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Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 4010) - Melbourne
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2065 - St Leonards
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5112 - Elizabeth Vale
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3199 - Frankston
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3000 - Melbourne
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Mazowieckie
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Poland
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Wielkopolskie
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Romania
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Cluj
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Romania
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Dolj
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Russian Federation
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Ivanovskaya Oblast
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Russian Federation
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Moskovskaya Oblast
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Russian Federation
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Moskva
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Russian Federation
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Volgogradskaya Oblast
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Russian Federation
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State/province [115]
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Yaroslavskaya Oblast
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Spain
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State/province [116]
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La Coruna
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Spain
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Madrid, Comunidad De
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Switzerland
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Geneve
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Switzerland
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Grisons
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Switzerland
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Ticino
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Switzerland
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Zurich
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United Kingdom
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Aberdeen City
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United Kingdom
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Bath And North East Somerset
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United Kingdom
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England
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United Kingdom
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Essex
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United Kingdom
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London, City Of
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United Kingdom
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Somerset
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United Kingdom
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Wales
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Eisai Inc.
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04586231
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04586231