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, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study
NCT ID: NCT05899049
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
249 participants
INTERVENTIONAL
2022-07-27
2027-06-07
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Pembrolizumab
Pembrolizumab 400 mg administered Q6W via IV infusion
Belzutifan
Belzutifan 120 mg administered QD via oral tablet
Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule
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.
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
Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule
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.
Pembrolizumab
Pembrolizumab 400 mg administered Q6W via IV infusion
Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule
Interventions
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Pembrolizumab
Pembrolizumab 400 mg administered Q6W via IV infusion
Belzutifan
Belzutifan 120 mg administered QD via oral tablet
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
Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 6009)
Chongqing, Chongqing Municipality, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)
Guangzhou, Guangdong, China
Guangzhou First People's Hospital ( Site 6007)
Guangzhou, Guangdong, China
Henan Cancer Hospital-Urology ( Site 6006)
Zhengzhou, Henan, China
Wuhan Union Hospital ( Site 6002)
Wuhan, Hubei, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 6019)
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)
Xi'an, Shaanxi, China
West China Hospital Sichuan University-Urology Surgery ( Site 6016)
Chengdu, Sichuan, China
The Second Hospital of Tianjin Medical University ( Site 6032)
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University ( Site 6024)
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing ( Site 6033)
Jiaxing, Zhejiang, China
Ningbo First Hospital-Urology ( Site 6028)
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)
Wenzhou, Zhejiang, China
Countries
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-6482-012 China Extension
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031210435
Identifier Type: REGISTRY
Identifier Source: secondary_id
PHRR210911-003887
Identifier Type: REGISTRY
Identifier Source: secondary_id
6482-012 China Extension
Identifier Type: -
Identifier Source: org_study_id