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NCT04241185 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)

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

Active
Registry status
Phase 3
Development phase
520
Enrollment target
20
Study locations

NCT04241185 is a Phase 3 study of Urinary Bladder Neoplasms that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 520 participants, above the 286-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (82% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT04241185, a Phase 3 study of Urinary Bladder Neoplasms, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.

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

Study Summary

Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of cancer that has not spread from the muscles in the bladder to other parts of the body. MIBC is treated by having surgery to remove the bladder (cystectomy). Not all people choose to have surgery and want to keep their bladder using other treatments. Chemoradiotherapy (CRT)- is a type of non-surgical treatment for MIBC which combines Chemotherapy (a treatment with medicine to destroy cancer cells or stop them growing) and Radiation therapy (a treatment that uses beams of intense energy \[like X-rays\] to shrink or get rid of tumors). Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand if the study medicine works. The goal of this study is to learn: 1. If a study medicine pembrolizumab given with Chemoradiotherapy (CRT) can help people live longer without their cancer growing, spreading, or coming back compared to placebo given with CRT. 2.About the safety and how well people tolerate CRT alone or in combination with pembrolizumab.

Conditions Studied

Urinary Bladder Neoplasms

Interventions

  • DRUG Pembrolizumab
  • DRUG Cisplatin
  • RADIATION Conventional Radiotherapy (Bladder only)
  • RADIATION Conventional Radiotherapy (Bladder and pelvic nodes)
  • RADIATION Hypofractionated Radiotherapy (Bladder only)

Study Locations (20)

New York

  • New York Oncology Hematology P.C ( Site 0024) - Albany
  • Roswell Park Cancer Institute ( Site 6009) - Buffalo
  • Winthrop University Hospital ( Site 0069) - Mineola
  • New York University Perlmutter Cancer Center ( Site 0001) - New York

Ohio

  • Fairview Hospital-Moll Cancer Center ( Site 6013) - Cleveland
  • Cleveland Clinic Main ( Site 0062) - Cleveland
  • Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 6012) - Mayfield Heights

Florida

  • Bay Pines VA Medical Center ( Site 0055) - Bay Pines
  • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0004) - Orlando

Kentucky

  • Norton Cancer Institute ( Site 0044) - Louisville
  • Pikeville Medical Center ( Site 0009) - Pikeville

New Jersey

  • Summit Medical Group Cancer Center ( Site 6008) - Florham Park
  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005) - Hackensack

South Carolina

  • Saint Francis Cancer Center ( Site 0026) - Greenville
  • Carolina Urologic Research Center ( Site 0002) - Myrtle Beach

District of Columbia

  • Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041) - Washington D.C.

Maryland

  • Baltimore VA Medical Center ( Site 0054) - Baltimore

Trial Details

FieldValue
Enrollment Target 520 participants
Start Date 2020-05-19
Est. Completion 2031-11-01
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 NCT04241185

The ClinicalTrials.gov registry entry for NCT04241185 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 520 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 286-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (82% 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 Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT04241185 reports 20 study locations spanning 11 distinct geographic areas - top geographies include New York, Ohio, Florida.

Frequently Asked Questions

What is clinical trial NCT04241185 about?

NCT04241185 is a clinical study titled "Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)". Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of cancer that has not spread from the muscles in the bladder to other parts of the body. MIBC is treated by having surgery to remove the bladder (cystectomy). Not all people choose to have surgery a...

What is the current status of trial NCT04241185?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 520 participants. The study started on 2020-05-19. Estimated completion is 2031-11-01.

What conditions does trial NCT04241185 study?

This clinical trial studies the following conditions: Urinary Bladder Neoplasms.

What interventions are being tested in trial NCT04241185?

The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), Conventional Radiotherapy (Bladder only) (RADIATION), Conventional Radiotherapy (Bladder and pelvic nodes) (RADIATION), Hypofractionated Radiotherapy (Bladder only) (RADIATION).

Who is sponsoring clinical trial NCT04241185?

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

Where is trial NCT04241185 being conducted?

This trial has 20 study locations across District of Columbia, Florida, Kentucky, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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