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
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
Study summary
The goal of this China extension 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 Chinese 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
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
Primary outcome measure(s)
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) — Up to approximately 58 months 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 BICR based on RECIST 1.1 will be presented.
Overall Survival (OS) — Up to approximately 58 months OS is defined as the time from randomization to death due to any cause.
Trial sites (17)
Facility
City
Region
Status
Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)
Beijing
Beijing Municipality
Chongqing University Cancer Hospital ( Site 6009)
Chongqing
Chongqing Municipality
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)
Guangzhou
Guangdong
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)
Guangzhou
Guangdong
Guangzhou First People's Hospital ( Site 6007)
Guangzhou
Guangdong
Henan Cancer Hospital-Urology ( Site 6006)
Zhengzhou
Henan
Wuhan Union Hospital ( Site 6002)
Wuhan
Hubei
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
Nanjing
Jiangsu
The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)
Suzhou
Jiangsu
The First Affiliated Hospital of Nanchang University ( Site 6019)
Nanchang
Jiangxi
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)
Xi'an
Shaanxi
West China Hospital Sichuan University-Urology Surgery ( Site 6016)
Chengdu
Sichuan
The Second Hospital of Tianjin Medical University ( Site 6032)
Tianjin
Tianjin Municipality
The First Affiliated Hospital, Zhejiang University ( Site 6024)
Hangzhou
Zhejiang
The First Hospital of Jiaxing ( Site 6033)
Jiaxing
Zhejiang
Ningbo First Hospital-Urology ( Site 6028)
Ningbo
Zhejiang
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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