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NCT04586231 · ClinicalTrials.gov registry record · Phase 3

A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

A Phase 3 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.

Active
Registry status
Phase 3
Development phase
747
Enrollment target
20
Study locations

NCT04586231: Active Phase 3 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.

NCT04586231 is a Phase 3 study of Carcinoma, Renal Cell that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 747 participants, above the 261-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (186% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04586231, a Phase 3 study of Carcinoma, Renal Cell, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
747 participants
Enrollment target
20
Study locations

Study Summary

This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.

Primary Outcome

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.

Conditions Studied

Carcinoma, Renal Cell

Interventions

  • DRUG Belzutifan
  • DRUG Cabozantinib
  • DRUG Lenvatinib

Study Locations (20)

California

  • Cedars Sinai Medical Center ( Site 0027) - Los Angeles
  • UCLA Hematology/Oncology - Santa Monica ( Site 0048) - Los Angeles
  • St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095) - Orange
  • UC Irvine Health ( Site 0029) - Orange
  • Providence Saint John's Health Center ( Site 0083) - Santa Monica

Florida

  • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0003) - Orlando
  • Orlando Health, Inc. ( Site 0035) - Orlando

Georgia

  • University Cancer & Blood Center, LLC ( Site 0057) - Athens
  • Emory University Hospital ( Site 0012) - Atlanta

Illinois

  • Rush University Medical Center ( Site 0040) - Chicago
  • Illinois Cancer Care, PC ( Site 0008) - Peoria

Arizona

  • Ironwood Cancer & Research Centers ( Site 0077) - Chandler

District of Columbia

  • Georgetown University Medical Center ( Site 0006) - Washington D.C.

Indiana

  • Parkview Cancer Institute ( Site 0088) - Fort Wayne

Kentucky

  • Norton Cancer Institute - St. Matthews ( Site 0065) - Louisville

Trial Details

FieldValue
Enrollment Target 747 participants
Start Date 2021-02-25
Est. Completion 2027-02-11
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What the registry record for NCT04586231 still lists

NCT04586231 is an interventional study that assigns participants to a tested intervention. The registered 747 participants enrollment target is mid-sized for trials with a published cap, above the 261-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (186% higher).

The record links to 1 condition, with Carcinoma, Renal Cell appearing as the primary indexed condition, and to 3 interventions - of which Belzutifan is the first listed.

NCT04586231 names 20 study sites across 13 states, led by California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT04586231 about?

NCT04586231 is a clinical study titled "A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)". This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progr...

What is the current status of trial NCT04586231?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 747 participants. The study started on 2021-02-25. Estimated completion is 2027-02-11.

What conditions does trial NCT04586231 study?

This clinical trial studies the following conditions: Carcinoma, Renal Cell.

What interventions are being tested in trial NCT04586231?

The interventions under investigation include: Belzutifan (DRUG), Cabozantinib (DRUG), Lenvatinib (DRUG).

Who is sponsoring clinical trial NCT04586231?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04586231 being conducted?

This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Carcinoma, Renal Cell

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04586231's enrollment target sits among peer trials

747 6th of 34 higher than 29 of 34 other Carcinoma, Renal Cell trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Carcinoma, Renal Cell trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04586231, the US trial registry maintained by the National Library of Medicine. NCT04586231 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.