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NCT05030506Active, not recruitingPhase 1

A Study of Belzutifan (MK-6482) as Monotherapy and in Combination With Lenvatinib (E7080/MK-7902) With or Without Pembrolizumab (MK-3475) in China Participants With Advanced Renal Cell Carcinoma (MK-6482-010)

An Open-Label, Phase 1 Study of MK-6482 as Monotherapy and in Combination With Lenvatinib (MK-7902) With or Without Pembrolizumab (MK-3475) in China Participants With Advanced Renal Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 18 Dec 2025

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles, and preliminary efficacy of belzutifan as monotherapy followed by belzutifan+lenvatinib combination therapy, as well as belzutifan combined with lenvatinib and pembrolizumab in China participants with advanced renal cell carcinoma.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
45 (estimated)
First submitted
30 Aug 2021
Start date
Oct 2021
Primary completion date
Jun 2027
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT05030506

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 45
  • From Oct 2021 to the primary completion date, Jun 2027
  • 5 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

  • Is a woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 24 hours prior to first dose of study intervention.
  • Has clinically significant hematuria, hematemesis or hemoptysis of red blood, or other history of significant bleeding within 3 months before administration of the first dose of study intervention.
  • Received colony-stimulating factors, granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant EPO within 28 days prior to the first dose of study intervention.
  • Has received prior treatment with belzutifan.
  • Has received prior treatment with lenvatinib.
  • Has received any type of systemic anticancer antibody (including investigational antibody) ≤28 days prior to allocation.
  • Has received / will be receiving any traditional Chinese medicines.
  • Has received prior radiotherapy within 2 weeks prior to first dose of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
  • Is receiving concomitant treatment, in therapeutic doses, with anticoagulants.
  • Is receiving chronic systemic steroids therapy (at doses \>10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
  • Is currently participating in a study of an investigational agent or is currently using an investigational device.
  • Has had major surgery within 4 weeks prior to first dose of study intervention.
    • For Belzutifan + Lenvatinib + Pembrolizumab treatment:
  • Has received a live vaccine within 30 days prior to the first dose of study intervention.

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.
  • Has a history of inflammatory bowel disease.
  • Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
  • Has other clinically significant disorders such as: A serious active non-healing wound/ulcer/bone fracture, requirement for hemodialysis or peritoneal dialysis or a history of allogenic tissue/solid organ transplantation.
  • Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
  • Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption.
  • Has an active infection requiring systemic therapy.
  • Has a known history of Human Immunodeficiency Virus (HIV) infection.
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection.
  • Has a known history of active tuberculosis.
  • Has known hypersensitivity or allergy to the active pharmaceutical ingredient or any component of the study intervention (belzutifan or lenvatinib) formulations.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has a history of hypersensitivity reaction to the active pharmaceutical ingredient or any component of pembrolizumab or monoclonal antibody (mAb).
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years.

Other

  • Has any of the following: A pulse oximeter reading \<92%, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has symptomatic pleural effusion.
  • Has radiographic evidence of intratumoral cavitation, encasement or invasion of a major blood vessel.

Who the study is looking for

  • Has a histologically confirmed diagnosis of unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
  • Has measurable disease per RECIST 1.1.
  • Has adequate organ function.
  • Has adequately controlled blood pressure (BP).
  • If participants received major surgery or radiation therapy of \>30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
  • Has resolution of the toxic effect(s) of the most recent prior therapy.
  • Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks prior to allocation.
  • Is Chinese descent, defined as both biological parents and all biological grandparents are of Chinese descent.
    • Male Participants:
    • \- Must be willing to use an adequate method of contraception.
    • Female Participants:
    • \- Must be a woman of non-childbearing potential (WONCBP) or have a negative urine or serum pregnancy test and must be willing to use an adequate method of contraception.
    • For Belzutifan + Lenvatinib treatment:
  • Has progressed on or after having received systemic treatment for locally advanced or metastatic RCC.
  • Has no more than 3 prior systemic regimens for locally advanced or metastatic RCC.
    • For Belzutifan + Lenvatinib + Pembrolizumab treatment:
    • \- Has received no prior systemic therapy for advanced RCC.

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

Full criteria on ClinicalTrials.gov

Sites (5)

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

SiteCityCountrySite status
Beijing Cancer hospital-Digestive Oncology ( Site 0001)
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
SUN YAT-SEN UNIVERSITY CANCER CENTRE-Urology Surgery Department ( Site 0005)
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
The Second Affiliated hospital of Zhejiang University school of medicine-Urology ( Site 0007)
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital ( Site 0003)
Coordinator of this site? Confirm its status
TianjinChinaUnknown status

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