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RecruitingLast updated: 5 February 2024

This Phase III trial is evaluating how safe and effective combinations of immunotherapy (pembrolizumab) and targeted therapies (lenvatinib, quavonlimab, belzutifan) are in people with advanced clear cell renal cell carcinomaAn 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)

Clinical summary

Summary

This is an open-label, randomised trial with one active comparator and two experimental arms. In Experimental Arm 1, participants will receive Pembrolizumab + Belzutifan + Lenvatinib. Pembrolizumab (400mg) will be administered intravenously once every 6 weeks (Q6W) fo rup to 18 administrations (up to ~2 years). Belzutifan (120mg) and lenvatinib (20mg) will be administered orally once daily (QD) until progressive disease or discontinuation. In Experimental Arm 2, participants will receive Pembrolizumab/Quavonlimab + Lenvatinib. Pembrolizumab/quavonlimab (co-formulation of pembrolizumab 400mg and quavonlimab 25mg) will be administered intravenously Q6W for up to 18 administrations (up to ~2 years). Lenvatinib (20mg) will be administered orally QD until progressive disease or discontinuation. In the Active Comparator group, participants will receive Pembrolizumab + Lenvatinib. Pembrolizumab (400mg) will be administered intravenously Q6W for up to 18 administrations (~2 years). Lenvatinib (20mg) will be administered orally QD until progressive disease or discontinuation.

Conditions

This trial is treating patients with renal cell carcinoma

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

III

More information

Trial Identifiers

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Trial sponsor

Merck

Scientific Title

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)

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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