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ACTIVE NOT RECRUITING 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)

NCT04626518 · View on ClinicalTrials.gov ↗

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

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04626518

The ClinicalTrials.gov registry entry for NCT04626518 describes a study currently listed as active not recruiting. It is categorized as Phase 1, 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 370 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 5 interventions — of which Pembrolizumab 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: NCT04626518 reports 20 study locations spanning 17 distinct geographic areas — top geographies include New York, New South Wales, Region M. de Santiago. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04626518?

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 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.

Related

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