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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04736706




Registration number
NCT04736706
Ethics application status
Date submitted
29/01/2021
Date registered
3/02/2021
Date last updated
12/03/2024

Titles & IDs
Public title
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Scientific title
An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Secondary ID [1] 0 0
MK-6482-012
Secondary ID [2] 0 0
6482-012
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
Other interventions - Pembrolizumab
Treatment: Drugs - Belzutifan
Other interventions - Pembrolizumab/Quavonlimab
Treatment: Drugs - Lenvatinib

Experimental: Pembrolizumab + Belzutifan + Lenvatinib - Participants will receive pembrolizumab 400 mg PLUS belzutifan 120 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered intravenously (IV) once every 6 weeks (Q6W) for up to 18 administrations (up to ~2 years). Belzutifan and lenvatinib will be administered orally once daily (QD) until progressive disease or discontinuation.

Experimental: Pembrolizumab/Quavonlimab + Lenvatinib - Participants will receive pembrolizumab/quavonlimab (co-formulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered IV Q6W for up to 18 administrations (up to ~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.

Active Comparator: Pembrolizumab + Lenvatinib - Participants will receive pembrolizumab 400 mg PLUS lenvatinib 20 mg. Pembrolizumab will be administered IV Q6W for up to 18 administrations (up to ~2 years). Lenvatinib will be administered orally QD until progressive disease or discontinuation.


Other interventions: Pembrolizumab
Pembrolizumab 400 mg administered Q6W via IV infusion

Treatment: Drugs: Belzutifan
Belzutifan 120 mg administered QD via oral tablet

Other interventions: Pembrolizumab/Quavonlimab
Pembrolizumab/quavonlimab is a co-formulated product composed of pembrolizumab 400 mg in combination with quavonlimab 25 mg, administered Q6W via IV infusion

Treatment: Drugs: Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 46 months
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 66 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
Timepoint [1] 0 0
Up to approximately 46 months
Secondary outcome [2] 0 0
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Timepoint [2] 0 0
Up to approximately 66 months
Secondary outcome [3] 0 0
Number of Participants Who Experienced At least One Adverse Event (AE)
Timepoint [3] 0 0
Up to approximately 66 months
Secondary outcome [4] 0 0
Number of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [4] 0 0
Up to approximately 66 months

Eligibility
Key inclusion criteria
- Has histologically confirmed diagnosis of RCC with clear cell component.

- Has received no prior systemic therapy for advanced ccRCC

- Male participants are abstinent from heterosexual intercourse or agree to use
contraception during and for at least 7 days after last dose of study intervention
with belzutifan and lenvatinib.

- Female participants are not pregnant or breastfeeding and are either not a woman of
child-bearing potential (WOCBP) or use a contraceptive method that is highly effective
or are abstinent from heterosexual intercourse during the intervention period and for
at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or for at least 30
days after last dose of lenvatinib or belzutifan, whichever occurs last

- Has adequately controlled blood pressure with or without antihypertensive medications

- Has adequate organ function.

- Participants receiving bone resorptive therapy must have therapy initiated at least 2
weeks prior to randomization/allocation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has a known additional malignancy that is progressing or has required active treatment
within the past 3 years

- Has had major surgery, other than nephrectomy within 4 weeks prior to randomization

- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis

- Has received prior radiotherapy within 2 weeks prior to first dose of study
intervention

- Has hypoxia or requires intermittent supplemental oxygen or requires chronic
supplemental oxygen

- Has clinically significant cardiac disease within 12 months from first dose of study
intervention

- Has a history of interstitial lung disease

- Has symptomatic pleural effusion; a participant who is clinically stable following
treatment of this condition is eligible

- Has preexisting gastrointestinal or non-gastrointestinal fistula

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive therapy within 7 days prior to the first dose
of study treatment

- Has a known psychiatric or substance abuse disorder that would interfere with
requirements of the study

- Has received a live or live-attenuated vaccine within 30 days before the first dose of
study drug; killed vaccines are allowed

- Has an active autoimmune disease that has required systemic treatment in the past 2
years

- Has a history of noninfectious pneumonitis that required steroids or has current
pneumonitis

- Has an active infection requiring systemic therapy

- Has a known history of human immunodeficiency virus (HIV) infection

- Has a known history of Hepatitis B

- Has radiographic evidence of intratumoral cavitation, encasement or invasion of a
major blood vessel

- Has clinically significant history of bleeding within 3 months prior to randomization

- 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
Open (masking not used)
Who is / are masked / blinded?



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
14/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/10/2026
Actual
Sample size
Target
1653
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital ( Site 4006) - Liverpool
Recruitment hospital [2] 0 0
Macquarie University ( Site 4007) - Macquarie University
Recruitment hospital [3] 0 0
Lyell McEwin Hospital ( Site 4004) - Elizabeth Vale
Recruitment hospital [4] 0 0
Monash Health ( Site 4008) - Clayton
Recruitment hospital [5] 0 0
Fiona Stanley Hospital ( Site 4009) - Murdock
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
6150 - Murdock
Recruitment outside Australia
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Moskva
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Istanbul
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Izmir
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Ukraine
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Cherkaska Oblast
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Ukraine
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Chernihivska Oblast
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Ukraine
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Dnipropetrovska Oblast
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Ukraine
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Ivano-Frankivska Oblast
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Ukraine
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Kharkivska Oblast
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Ukraine
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Kyivska Oblast
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Ukraine
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Lvivska Oblast
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United Kingdom
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Cambridgeshire
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England
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United Kingdom
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London, City Of

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eisai Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus
belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab
plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell
carcinoma (ccRCC).

The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to
pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall
survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus
lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in
advanced ccRCC participants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04736706
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04736706