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NCT05943106 · ClinicalTrials.gov registry record · Phase 3

BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants

A Phase 3 study of Non-muscle Invasive Bladder Cancer, sponsored by AstraZeneca.

Active
Registry status
Phase 3
Development phase
100
Enrollment target
19
Study locations

NCT05943106 is a Phase 3 study of Non-muscle Invasive Bladder Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 100 participants, below the 230-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (57% lower). The trial reports 19 study locations across 16 states.

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The verdict

NCT05943106, a Phase 3 study of Non-muscle Invasive Bladder Cancer, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
100 participants
Enrollment target
19
Study locations

Study Summary

The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed diagnosis of high-risk non-muscle-invasive bladder cancer (NMIBC), who have received no prior systemic therapy for NMIBC, and who are BCG-naïve.

Conditions Studied

Non-muscle Invasive Bladder Cancer

Interventions

  • BIOLOGICAL Durvalumab
  • BIOLOGICAL BCG

Study Locations (19)

Florida

  • Research Site - Hialeah
  • Research Site - Jacksonville

Maryland

  • Research Site - Baltimore
  • Research Site - Hanover

Michigan

  • Research Site - Royal Oak
  • Research Site - Troy

Arizona

  • Research Site - Phoenix

Arkansas

  • Research Site - Little Rock

California

  • Research Site - San Diego

Colorado

  • Research Site - Lakewood

Indiana

  • Research Site - Greenwood

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-08-11
Est. Completion 2027-03-31
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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What the Registry Record Tells You About NCT05943106

The ClinicalTrials.gov registry entry for NCT05943106 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 230-participant average among 28 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (57% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.

NCT05943106 reports 19 study locations spanning 16 distinct geographic areas - top geographies include Florida, Maryland, Michigan.

Frequently Asked Questions

What is clinical trial NCT05943106 about?

NCT05943106 is a clinical study titled "BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants". The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed diagnosis of high-risk non-muscle-invasive bladder cancer (NMIBC), who have re...

What is the current status of trial NCT05943106?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2023-08-11. Estimated completion is 2027-03-31.

What conditions does trial NCT05943106 study?

This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer.

What interventions are being tested in trial NCT05943106?

The interventions under investigation include: Durvalumab (BIOLOGICAL), BCG (BIOLOGICAL).

Who is sponsoring clinical trial NCT05943106?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05943106 being conducted?

This trial has 19 study locations across Arizona, Arkansas, California, Colorado, Florida. 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.