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NCT05899049Active, not recruitingPhase 3

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

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)

Source: ClinicalTrials.gov · Last updated 20 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
251 (actual)
First submitted
2 Jun 2023
Start date
27 Jul 2022
Primary completion date
4 Feb 2026
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT05899049

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 251
  • From 27 Jul 2022 to the primary completion date, 4 Feb 2026
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has had major surgery, other than nephrectomy within 4 weeks prior to randomization
  • Has received prior radiotherapy within 2 weeks prior to first dose of study intervention
  • 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 received a live or live-attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed
  • Has clinically significant history of bleeding within 3 months prior to randomization
  • Has had an allogenic tissue/solid organ transplant

Other illness

  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • 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 known psychiatric or substance abuse disorder that would interfere with requirements of the study
  • 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

Other

  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has hypoxia or requires intermittent supplemental oxygen or requires chronic supplemental oxygen
  • Has radiographic evidence of intratumoral cavitation, encasement or invasion of a major blood vessel

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
West China Hospital Sichuan University-Urology Surgery ( Site 6016)
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Chongqing University Cancer Hospital ( Site 6009)
Coordinator of this site? Confirm its status
ChongqingChinaUnknown status
Guangzhou First People's Hospital ( Site 6007)
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
The First Affiliated Hospital, Zhejiang University ( Site 6024)
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
The First Hospital of Jiaxing ( Site 6033)
Coordinator of this site? Confirm its status
JiaxingChinaUnknown status
The First Affiliated Hospital of Nanchang University ( Site 6019)
Coordinator of this site? Confirm its status
NanchangChinaUnknown status
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Ningbo First Hospital-Urology ( Site 6028)
Coordinator of this site? Confirm its status
NingboChinaUnknown status
The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)
Coordinator of this site? Confirm its status
SuzhouChinaUnknown status
The Second Hospital of Tianjin Medical University ( Site 6032)
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)
Coordinator of this site? Confirm its status
WenzhouChinaUnknown status
Wuhan Union Hospital ( Site 6002)
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)
Coordinator of this site? Confirm its status
Xi'anChinaUnknown status
Henan Cancer Hospital-Urology ( Site 6006)
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.