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NCT04195750 · ClinicalTrials.gov registry record · Phase 3

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)

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

Active
Registry status
Phase 3
Development phase
755
Enrollment target
20
Study locations

NCT04195750: Active Phase 3 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.

NCT04195750 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 755 participants, above the 261-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (189% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04195750, 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
755 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.

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 is presented here.

Conditions Studied

Carcinoma, Renal Cell

Interventions

  • DRUG Belzutifan
  • DRUG Everolimus

Study Locations (20)

Massachusetts

  • Massachusetts General Hospital ( Site 1558) - Boston
  • Beth Israel Deaconess Medical Center ( Site 1501) - Boston
  • Dana Farber Cancer Institute ( Site 1505) - Boston

California

  • University of California San Diego Moores Cancer Center ( Site 1546) - La Jolla
  • St Joseph Heritage Healthcare ( Site 1531) - Santa Rosa

Colorado

  • University Of Colorado ( Site 1540) - Aurora
  • UCHealth Highlands Ranch Hospital ( Site 1560) - Highlands Ranch

Alabama

  • University of Alabama - Birmingham ( Site 1538) - Birmingham

District of Columbia

  • Sibley Memorial Hospital ( Site 1559) - Washington D.C.

Georgia

  • Northwest Georgia Oncology Centers PC ( Site 1520) - Marietta

Illinois

  • The University of Chicago Medical Center ( Site 1539) - Chicago

Louisiana

  • Ochsner Medical Center ( Site 1522) - New Orleans

Trial Details

FieldValue
Enrollment Target 755 participants
Start Date 2020-02-27
Est. Completion 2026-09-17
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What the registry record for NCT04195750 still lists

NCT04195750 is an interventional study that assigns participants to a tested intervention. The registered 755 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 (189% higher).

The record links to 1 condition, with Carcinoma, Renal Cell appearing as the primary indexed condition, and to 2 interventions - of which Belzutifan is the first listed.

NCT04195750 names 20 study sites across 16 states, led by Massachusetts, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT04195750 about?

NCT04195750 is a clinical study titled "A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)". The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to over...

What is the current status of trial NCT04195750?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 755 participants. The study started on 2020-02-27. Estimated completion is 2026-09-17.

What conditions does trial NCT04195750 study?

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

What interventions are being tested in trial NCT04195750?

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

Who is sponsoring clinical trial NCT04195750?

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

Where is trial NCT04195750 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, 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 NCT04195750's enrollment target sits among peer trials

755 4th of 34 higher than 31 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 NCT04195750, the US trial registry maintained by the National Library of Medicine. NCT04195750 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.