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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)
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)
Secondary ID [1] 0 0
MK-6482-022
Secondary ID [2] 0 0
6482-022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-Free Survival (DFS)
Timepoint [1] 0 0
Up to approximately 54 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 89 months
Secondary outcome [2] 0 0
Number of Participants Who Experience at Least One Adverse Event (AE)
Timepoint [2] 0 0
Up to approximately 66 weeks
Secondary outcome [3] 0 0
Number of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [3] 0 0
Up to approximately 54 weeks
Secondary outcome [4] 0 0
Disease Recurrence-Specific Survival 1 (DRSS1)
Timepoint [4] 0 0
Up to approximately 54 months
Secondary outcome [5] 0 0
Disease Recurrence-Specific Survival 2 (DRSS2)
Timepoint [5] 0 0
Up to approximately 54 months
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline (Day 1) and up to approximately 36 months
Secondary outcome [7] 0 0
Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
Timepoint [7] 0 0
Baseline (Day 1) and up to approximately 36 months
Secondary outcome [8] 0 0
Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6 and 7 Score
Timepoint [8] 0 0
Baseline (Day 1) and up to approximately 36 months
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline (Day 1) and up to approximately 36 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/09/2029
Actual
Sample size
Target
1800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 0002) - Blacktown
Recruitment hospital [2] 0 0
Macquarie University-MQ Health Clinical Trials Unit ( Site 0003) - Macquarie University
Recruitment hospital [3] 0 0
Tamworth Hospital-North West Cancer Centre ( Site 0006) - North Tamworth
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si - Brisbane
Recruitment hospital [5] 0 0
Lyell McEwin Hospital-Oncology Clinical Trials Unit ( Site 0008) - Elizabeth Vale
Recruitment hospital [6] 0 0
Austin Health-Cancer Clinical Trials Centre ( Site 0005) - Heidelberg
Recruitment hospital [7] 0 0
Fiona Stanley Hospital-Medical Oncology ( Site 0004) - Murdoch
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
2340 - North Tamworth
Recruitment postcode(s) [4] 0 0
4029 - Brisbane
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
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Thailand
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Songkhla
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Ankara
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Istanbul
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Adana
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Izmir
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Hammersmith And Fulham
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
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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
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


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