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)

  • STATUS
    Recruiting
  • End date
    Oct 29, 2026
  • participants needed
    1653
  • sponsor
    Merck Sharp & Dohme LLC
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Updated on 27 October 2022
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systemic therapy
carcinoma
pembrolizumab
lenvatinib
clear cell renal cell carcinoma

Summary

The goal of this 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 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.

Details
Condition Carcinoma, Renal Cell
Treatment Pembrolizumab, Lenvatinib, Belzutifan, Pembrolizumab/Quavonlimab
Clinical Study IdentifierNCT04736706
SponsorMerck Sharp & Dohme LLC
Last Modified on27 October 2022

Eligibility

 Yes No Not Sure

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
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