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NCT04626518 · ClinicalTrials.gov registry record · Phase 1

Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)

A Phase 1 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.

Active
Registry status
Phase 1
Development phase
370
Enrollment target
20
Study locations

NCT04626518 is a Phase 1 study of Carcinoma, Renal Cell that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 370 participants, above the 272-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (36% higher). The trial reports 20 study locations across 17 states.

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The verdict

NCT04626518, a Phase 1 study of Carcinoma, Renal Cell, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
370 participants
Enrollment target
20
Study locations

Study Summary

Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

Conditions Studied

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Belzutifan
  • DRUG Lenvatinib
  • BIOLOGICAL MK-4830
  • BIOLOGICAL Pembrolizumab/Quavonlimab

Study Locations (20)

New York

  • Laura and Isaac Perlmutter Cancer Center ( Site 3016) - New York
  • Memorial Sloan Kettering Cancer Center ( Site 3002) - New York

New South Wales

  • Blacktown Hospital ( Site 3601) - Blacktown
  • St George Hospital ( Site 3602) - Kogarah

Region M. de Santiago

  • FALP-UIDO ( Site 4100) - Santiago
  • Bradfordhill-Clinical Area ( Site 4101) - Santiago

California

  • University of California at San Francisco ( Site 3008) - San Francisco

Connecticut

  • Yale-New Haven Hospital-Yale Cancer Center ( Site 3011) - New Haven

Illinois

  • University of Chicago ( Site 3013) - Chicago

Iowa

  • University of Iowa ( Site 3012) - Iowa City

Michigan

  • Henry Ford Health System ( Site 3014) - Detroit

Trial Details

FieldValue
Enrollment Target 370 participants
Start Date 2020-12-17
Est. Completion 2026-05-31
Phase Phase 1

Sponsor

Merck Sharp & Dohme

558 total trials

What the Registry Record Tells You About NCT04626518

The ClinicalTrials.gov registry entry for NCT04626518 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 272-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (36% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Carcinoma, Renal Cell appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT04626518 reports 20 study locations spanning 17 distinct geographic areas - top geographies include New York, New South Wales, Region M. de Santiago.

Frequently Asked Questions

What is clinical trial NCT04626518 about?

NCT04626518 is a clinical study titled "Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)". Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participant...

What is the current status of trial NCT04626518?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 370 participants. The study started on 2020-12-17. Estimated completion is 2026-05-31.

What conditions does trial NCT04626518 study?

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

What interventions are being tested in trial NCT04626518?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Belzutifan (DRUG), Lenvatinib (DRUG), MK-4830 (BIOLOGICAL), Pembrolizumab/Quavonlimab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04626518?

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

Where is trial NCT04626518 being conducted?

This trial has 20 study locations across California, Connecticut, Illinois, Iowa, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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