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NCT03036098 · ClinicalTrials.gov registry record · Phase 3

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

A Phase 3 study of Urothelial Cancer, sponsored by Bristol-Myers Squibb.

Active
Registry status
Phase 3
Development phase
1,314
Enrollment target
20
Study locations

NCT03036098 is a Phase 3 study of Urothelial Cancer that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 1,314 participants, above the 522-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (152% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT03036098, a Phase 3 study of Urothelial Cancer, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,314 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

Conditions Studied

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Gemcitabine
  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab

Study Locations (20)

Massachusetts

  • Local Institution - 0056 - Boston
  • Local Institution - 0073 - Boston
  • Local Institution - 0208 - Boston
  • Local Institution - 0207 - Milford

Florida

  • Local Institution - 0051 - Boca Raton
  • Local Institution - 0087 - Fort Lauderdale
  • Local Institution - 0062 - Jacksonville

California

  • Local Institution - 0115 - Fresno
  • St Joseph Heritage Healthcare - Santa Rosa

Georgia

  • Local Institution - 0004 - Athens
  • Local Institution - 0033 - Thomasville

Missouri

  • Local Institution - 0032 - Kansas City
  • Local Institution - 0095 - St Louis

Alaska

  • Local Institution - 0001 - Anchorage

Illinois

  • Local Institution - 0046 - Chicago

Louisiana

  • Local Institution - 0117 - New Orleans

Trial Details

FieldValue
Enrollment Target 1,314 participants
Start Date 2017-03-24
Est. Completion 2026-05-15
Phase Phase 3

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT03036098

The ClinicalTrials.gov registry entry for NCT03036098 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,314 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 522-participant average among 25 other Urothelial Cancer trials with a reported enrollment target (152% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

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

NCT03036098 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Massachusetts, Florida, California.

Frequently Asked Questions

What is clinical trial NCT03036098 about?

NCT03036098 is a clinical study titled "Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer". The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or...

What is the current status of trial NCT03036098?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,314 participants. The study started on 2017-03-24. Estimated completion is 2026-05-15.

What conditions does trial NCT03036098 study?

This clinical trial studies the following conditions: Urothelial Cancer.

What interventions are being tested in trial NCT03036098?

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

Who is sponsoring clinical trial NCT03036098?

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

Where is trial NCT03036098 being conducted?

This trial has 20 study locations across Alaska, California, Florida, Georgia, Illinois. 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 Editorial

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.