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NCT03924856 · ClinicalTrials.gov registry record · Phase 3

Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)

A Phase 3 study of Bladder Cancer, sponsored by Merck Sharp & Dohme.

Active
Registry status
Phase 3
Development phase
907
Enrollment target
20
Study locations

NCT03924856 is a Phase 3 study of Bladder Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 907 participants, below the 12,749-participant average among 175 other Bladder Cancer trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT03924856, a Phase 3 study of Bladder Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
907 participants
Enrollment target
20
Study locations

Study Summary

A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.

Conditions Studied

Bladder Cancer

Interventions

  • DRUG Pembrolizumab
  • DRUG Placebo
  • DRUG Cisplatin
  • DRUG Gemcitabine
  • PROCEDURE Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])

Study Locations (20)

California

  • Scripps MD Anderson ( Site 0010) - La Jolla
  • Providence Saint John's Health Center ( Site 0075) - Santa Monica

Indiana

  • Parkview Cancer Institute ( Site 0077) - Fort Wayne
  • Indiana University Melvin and Bren Simon Cancer Center ( Site 0004) - Indianapolis

Texas

  • MD Anderson Cancer Center ( Site 0063) - Houston
  • Central Texas Veterans Healthcare System ( Site 0057) - Temple

District of Columbia

  • Georgetown University Medical Center ( Site 0022) - Washington D.C.

Florida

  • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005) - Orlando

Louisiana

  • Ochsner Medical Center ( Site 0049) - New Orleans

Maine

  • New England Cancer Specialists ( Site 0070) - Scarborough

Massachusetts

  • UMass Memorial Medical Center ( Site 0051) - Worcester

Trial Details

FieldValue
Enrollment Target 907 participants
Start Date 2019-06-13
Est. Completion 2026-09-01
Phase Phase 3

Sponsor

Merck Sharp & Dohme

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03924856

The ClinicalTrials.gov registry entry for NCT03924856 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 907 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,749-participant average among 175 other Bladder Cancer trials with a reported enrollment target (93% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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

NCT03924856 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Indiana, Texas.

Frequently Asked Questions

What is clinical trial NCT03924856 about?

NCT03924856 is a clinical study titled "Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)". A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.

What is the current status of trial NCT03924856?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 907 participants. The study started on 2019-06-13. Estimated completion is 2026-09-01.

What conditions does trial NCT03924856 study?

This clinical trial studies the following conditions: Bladder Cancer.

What interventions are being tested in trial NCT03924856?

The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) (PROCEDURE).

Who is sponsoring clinical trial NCT03924856?

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

Where is trial NCT03924856 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Indiana, Louisiana. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.