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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05239728
Registration number
NCT05239728
Ethics application status
Date submitted
4/02/2022
Date registered
15/02/2022
Titles & IDs
Public title
A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)
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Scientific title
A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)
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Secondary ID [1]
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MK-6482-022
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Secondary ID [2]
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6482-022
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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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Non melanoma skin cancer
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Cancer
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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: Other - Pembrolizumab
Treatment: Drugs - Placebo
Experimental: Belzutifan + Pembrolizumab - Participants receive belzutifan 120 mg orally once daily (QD) for up to approximately 54 weeks PLUS pembrolizumab 400 mg via intravenous (IV) infusion once every 6 weeks (Q6W) for up to 9 administrations (up to approximately 54 weeks).
Experimental: Placebo + Pembrolizumab - Participants receive placebo orally QD for up to approximately 54 weeks PLUS pembrolizumab 400 mg via IV infusion once Q6W for up to 9 administrations (up to approximately 54 weeks).
Treatment: Drugs: Belzutifan
Three 40 mg tablets given as a single oral 120 mg dose.
Treatment: Other: Pembrolizumab
400 mg via IV infusion
Treatment: Drugs: Placebo
Oral tablet
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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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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Disease-Free Survival (DFS)
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Assessment method [1]
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DFS is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es) as assessed by investigator, or death due to any cause, whichever occurs first. The DFS for all participants will be presented.
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Timepoint [1]
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Up to approximately 54 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [1]
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Up to approximately 89 months
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Secondary outcome [2]
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Number of Participants Who Experience at Least One Adverse Event (AE)
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Assessment method [2]
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An 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. The number of participants who experienced an AE will be reported.
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Timepoint [2]
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Up to approximately 66 weeks
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Secondary outcome [3]
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Number of Participants Who Discontinue Study Treatment Due to an AE
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Assessment method [3]
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An 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. The number of participants who discontinued the study due to an AE will be reported.
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Timepoint [3]
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Up to approximately 54 weeks
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Secondary outcome [4]
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Disease Recurrence-Specific Survival 1 (DRSS1)
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Assessment method [4]
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DRSS1 is defined as the time from randomization to the first documented local recurrence of RCC as assessed by the investigator. For DRSS1, only local recurrence is counted as an event.
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Timepoint [4]
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Up to approximately 54 months
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Secondary outcome [5]
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Disease Recurrence-Specific Survival 2 (DRSS2)
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Assessment method [5]
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DRSS2 is defined as the time from randomization to the first documented local recurrence with visceral lesion or occurrence of distant kidney cancer metastasis(es) with visceral lesion, whichever occurs first, as assessed by investigator.
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Timepoint [5]
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Up to approximately 54 months
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Secondary outcome [6]
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Change From Baseline 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
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Assessment method [6]
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The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of participants with cancer. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" 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 combined scores will be presented.
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Timepoint [6]
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Baseline (Day 1) and up to approximately 36 months
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Secondary outcome [7]
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Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
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Assessment method [7]
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The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented.
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Timepoint [7]
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Baseline (Day 1) and up to approximately 36 months
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Secondary outcome [8]
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Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6 and 7 Score
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Assessment method [8]
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The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher score indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented.
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Timepoint [8]
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Baseline (Day 1) and up to approximately 36 months
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Secondary outcome [9]
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Change From Baseline in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score
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Assessment method [9]
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The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer. 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 the score of FKSI-DRS Items 1-9 will be presented.
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Timepoint [9]
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Baseline (Day 1) and up to approximately 36 months
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Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:
* Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
* Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:
1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0
2. High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0
3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, =2 years from nephrectomy (metachronous)
* Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
* Must have undergone a nephrectomy and/or metastasectomy =12 weeks prior to randomization
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization.
* Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo
* Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occurs last
* Has 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
* Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization
* Has a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
* Has clinically significant cardiovascular disease within 6 months from first dose of study intervention
* Has other clinically significant disorders such as: serious active nonhealing wound/ulcer/bone fracture; requirement for hemodialysis or peritoneal dialysis
* Has preexisting brain or bone metastatic lesions
* Has received prior systemic therapy for RCC
* Has received prior radiotherapy for RCC
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines are allowed
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy is allowed
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection, requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection, a known history of Hepatitis B or known active Hepatitis C virus infection
* Has had an allogenic tissue/solid organ transplant
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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
15/03/2022
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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
28/09/2029
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Actual
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Sample size
Target
1800
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 0002) - Blacktown
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Recruitment hospital [2]
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Macquarie University-MQ Health Clinical Trials Unit ( Site 0003) - Macquarie University
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Recruitment hospital [3]
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Tamworth Hospital-North West Cancer Centre ( Site 0006) - North Tamworth
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Recruitment hospital [4]
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Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si - Brisbane
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Recruitment hospital [5]
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Lyell McEwin Hospital-Oncology Clinical Trials Unit ( Site 0008) - Elizabeth Vale
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Austin Health-Cancer Clinical Trials Centre ( Site 0005) - Heidelberg
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Recruitment hospital [7]
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Fiona Stanley Hospital-Medical Oncology ( Site 0004) - Murdoch
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Recruitment postcode(s) [1]
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2148 - Blacktown
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2109 - Macquarie University
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2340 - North Tamworth
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4029 - Brisbane
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Recruitment postcode(s) [5]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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6150 - Murdoch
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Recruitment outside Australia
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Distrito Federal
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Gerona
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Istanbul
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Adana
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England
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United Kingdom
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London, City Of
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).
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Trial website
https://clinicaltrials.gov/study/NCT05239728
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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/NCT05239728