NCT04736706 : 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)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Urinary System<br/>CancersCancer LocationUrinary System
Cancers

Systemic therapy | Urinary systemRenal cell carcinoma

Trial Overview Read MoreRead more

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 carcinoma.
 

This trial is treating patients with renal cell carcinoma.

This is a systemic therapy trial.

You may be able to join this trial if:

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

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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)

Commercial Sponsor

Merck

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.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Genitourinary Research Study Coordinator
gu.oncresearch@monashhealth.org
0436387664

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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