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NCT04626479 · ClinicalTrials.gov registry record · Phase 1

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

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

Active
Registry status
Phase 1
Development phase
400
Enrollment target
20
Study locations

NCT04626479: Active Phase 1 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.

NCT04626479 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 400 participants, above the 272-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (47% 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

NCT04626479, 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
400 participants
Enrollment target
20
Study locations

Study Summary

Substudy 03A 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 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) 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.

Primary Outcome

DLTs are defined as one or more of the following toxicities: (1) grade (gr) 4 nonhematologic toxicity (2) gr 4 hematologic toxicity lasting \>7 days OR gr 4 platelet count decreased of any duration OR gr 3 platelet count decreased if associated with bleeding (3) gr 3 nonhematologic toxicity except gr 3 fatigue (lasting ≤3 days), diarrhea, nausea, vomiting or rash without standard of care (4) gr 3 or 4 nonhematologic abnormality if medical intervention is required or if it leads to hospitalizatio

Conditions Studied

Carcinoma, Renal Cell

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Belzutifan
  • DRUG Lenvatinib
  • BIOLOGICAL Pembrolizumab/Quavonlimab
  • BIOLOGICAL Favezelimab/Pembrolizumab

Study Locations (20)

Region M. de Santiago

  • FALP-UIDO ( Site 2100) - Santiago
  • Oncovida ( Site 2107) - Santiago
  • Bradfordhill-Clinical Area ( Site 2101) - Santiago

New York

  • Laura and Isaac Perlmutter Cancer Center ( Site 1016) - New York
  • Memorial Sloan Kettering Cancer Center ( Site 1002) - New York

New South Wales

  • Western Sydney Local Health District ( Site 1601) - Blacktown
  • St George Hospital ( Site 1602) - Kogarah

California

  • University of California at San Francisco ( Site 1008) - San Francisco

Connecticut

  • Yale-New Haven Hospital-Yale Cancer Center ( Site 1011) - New Haven

Illinois

  • University of Chicago ( Site 1013) - Chicago

Iowa

  • University of Iowa ( Site 1012) - Iowa City

Michigan

  • Henry Ford Health System ( Site 1014) - Detroit

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2020-12-16
Est. Completion 2026-05-31
Phase Phase 1
Merck Sharp & Dohme

558 total trials

What the registry record for NCT04626479 still lists

NCT04626479 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 272-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (47% higher).

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.

NCT04626479 names 20 study sites across 16 states, led by Region M. de Santiago, New York, New South Wales.

Frequently Asked Questions

What is clinical trial NCT04626479 about?

NCT04626479 is a clinical study titled "Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)". Substudy 03A 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 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participant...

What is the current status of trial NCT04626479?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 400 participants. The study started on 2020-12-16. Estimated completion is 2026-05-31.

What conditions does trial NCT04626479 study?

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

What interventions are being tested in trial NCT04626479?

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

Who is sponsoring clinical trial NCT04626479?

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

Where is trial NCT04626479 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.

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 NCT04626479's enrollment target sits among peer trials

400 7th of 34 higher than 28 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 NCT04626479, the US trial registry maintained by the National Library of Medicine. NCT04626479 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.