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NCT03661320 · ClinicalTrials.gov registry record · Phase 3

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

A Phase 3 study of Urinary Bladder Neoplasms and Muscle-invasive Bladder Cancer, sponsored by Bristol-Myers Squibb.

Active
Registry status
Phase 3
Development phase
855
Enrollment target
20
Study locations

NCT03661320 is a Phase 3 study of Urinary Bladder Neoplasms and Muscle-invasive Bladder Cancer that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 855 participants, above the 268-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (219% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT03661320, a Phase 3 study of Urinary Bladder Neoplasms and Muscle-invasive Bladder Cancer, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.

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

Study Summary

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

Conditions Studied

Urinary Bladder Neoplasms Muscle-invasive Bladder Cancer

Interventions

  • DRUG Cisplatin
  • DRUG Gemcitabine
  • BIOLOGICAL Nivolumab

Study Locations (20)

Massachusetts

  • Local Institution - 0009 - Boston
  • Local Institution - 0166 - Boston
  • Local Institution - 0209 - Boston

New York

  • Local Institution - 0029 - Albany
  • Local Institution - 0069 - Lake Success
  • Local Institution - 0047 - New York

Florida

  • Local Institution - 0036 - Pensacola
  • Local Institution - 0004 - Tampa

Illinois

  • Local Institution - 0005 - Chicago
  • Local Institution - 0006 - Peoria

Minnesota

  • Local Institution - 0025 - Minneapolis
  • Local Institution - 0129 - Minneapolis

Nebraska

  • Local Institution - 0183 - Omaha
  • Local Institution - 0001 - Omaha

Arizona

  • Local Institution - 0022 - Tucson

California

  • UC Davis Comprehensive Cancer Center - Sacramento

Trial Details

FieldValue
Enrollment Target 855 participants
Start Date 2018-11-06
Est. Completion 2027-12-30
Phase Phase 3

Sponsor

Bristol-Myers Squibb

1,025 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03661320

The ClinicalTrials.gov registry entry for NCT03661320 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 855 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 268-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target (219% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.

NCT03661320 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Massachusetts, New York, Florida.

Frequently Asked Questions

What is clinical trial NCT03661320 about?

NCT03661320 is a clinical study titled "A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer". The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MI...

What is the current status of trial NCT03661320?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 855 participants. The study started on 2018-11-06. Estimated completion is 2027-12-30.

What conditions does trial NCT03661320 study?

This clinical trial studies the following conditions: Urinary Bladder Neoplasms, Muscle-invasive Bladder Cancer.

What interventions are being tested in trial NCT03661320?

The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Nivolumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03661320?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03661320 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.