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ACTIVE NOT RECRUITING Phase 3

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

NCT04586231 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

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

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04586231

The ClinicalTrials.gov registry entry for NCT04586231 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 747 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04586231 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04586231?

The interventions under investigation include: Belzutifan (DRUG), Cabozantinib (DRUG), Lenvatinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04586231?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial