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RECRUITING

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

NCT04165798 · View on ClinicalTrials.gov ↗

Study Summary

This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.

Interventions

  • DIAGNOSTIC_TEST Tumor Imaging
  • PROCEDURE Tumor Tissue Collection
  • PROCEDURE Blood Sample Collection

Study Locations (20)

California

  • City of Hope ( Site 0014) — Duarte
  • UCSF Medical Center at Mission Bay ( Site 0007) — San Francisco

Massachusetts

  • Massachusetts General Hospital ( Site 0003) — Boston
  • Dana Farber Cancer Institute ( Site 0002) — Boston

Ohio

  • Cleveland Clinic Main ( Site 0006) — Cleveland
  • Ohio State University Comprehensive Cancer Center ( Site 0015) — Columbus

Arizona

  • Banner MD Anderson Cancer Center ( Site 0001) — Gilbert

District of Columbia

  • Georgetown University ( Site 0036) — Washington D.C.

Kentucky

  • University of Kentucky Markey Cancer Center ( Site 0019) — Lexington

Maryland

  • MedStar Franklin Square Medical Center ( Site 0033) — Baltimore

Nebraska

  • Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) — Omaha

Trial Details

FieldValue
Enrollment Target 1,065 participants
Start Date 2019-12-19
Est. Completion 2032-02-13

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04165798

The ClinicalTrials.gov registry entry for NCT04165798 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 1,065 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, Non-Small-Cell Lung appearing as the primary indexed condition, and to 3 interventions — of which Tumor Imaging 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: NCT04165798 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, Massachusetts, Ohio. 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 NCT04165798 about?

NCT04165798 is a clinical study titled "KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)". This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substud...

What is the current status of trial NCT04165798?

This trial is currently recruiting. The enrollment target is 1,065 participants. The study started on 2019-12-19. Estimated completion is 2032-02-13.

What conditions does trial NCT04165798 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small-Cell Lung. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04165798?

The interventions under investigation include: Tumor Imaging (DIAGNOSTIC_TEST), Tumor Tissue Collection (PROCEDURE), Blood Sample Collection (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04165798?

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 NCT04165798 being conducted?

This trial has 20 study locations across Arizona, California, District of Columbia, Kentucky, Maryland. 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