Trial Purpose

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.

Learn More on ClinicalTrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT04736706

When speaking to your doctor, please have the trial identifier number available.

About The Study

All patients who enrol in the trial will receive medication while on the study.

33% will receive pembrolizumab plus MK-6482 and lenvatinib

33% will receive MK-1308A (pembrolizumab with MK-1308) plus lenvatinib

33% will receive pembrolizumab plus lenvatinib

*A computer will decide which group you are put in. You have a 1 in 3 chance of getting put in each group. You, your trial doctor and the trial staff will know what you are getting.

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Phase 3

Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics, or physician offices.

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Dates

  • Actual study start date 14 April 2021
  • Estimated primary completion date 29 October 2026
  • Estimated study completion date 29 October 2026

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

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Conditions

Carcinoma, Renal Cell

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Age Range

18 - No Age Maximum

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Sex

All

Trial locations

Locations provided may not reflect the most current site information. Please call the number provided in the location results to confirm.