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)

  • STATUS
    Recruiting
  • End date
    Dec 28, 2023
  • participants needed
    45
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 10 August 2022
systemic therapy
serum pregnancy test
measurable disease
carcinoma
major surgery
pembrolizumab
lenvatinib
advanced renal cell carcinoma
clear cell renal cell carcinoma

Summary

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.

Details
Condition Renal Cell Carcinoma
Treatment Pembrolizumab, Lenvatinib, Belzutifan
Clinical Study IdentifierNCT05030506
SponsorMerck Sharp & Dohme LLC
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 any of the following: A pulse oximeter reading <92%, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
Has clinically significant cardiac disease
Has symptomatic pleural effusion
Has a history of inflammatory bowel disease
Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
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
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
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 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 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
Have received / be receiving any traditional Chinese medicines or herbal supplements
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 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 radiographic evidence of intratumoral cavitation, encasement or invasion of a major blood vessel
Has known hypersensitivity or allergy to the active pharmaceutical ingredient or any component of the study intervention (belzutifan or lenvatinib) formulations
Has had major surgery within 4 weeks prior to first dose of study intervention
For Belzutifan + Lenvatinib + Pembrolizumab treatment
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
Has received a live vaccine within 30 days prior to the first dose of study intervention
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