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

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 223-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (55% lower). The trial reports 19 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

A PRAE is defined as an AE that has been assessed by the Investigator to be possibly related to study treatment. A PRAE will be included if it has onset or worsens (by Investigator report of an increase in CTCAE (common terminology criteria for adverse events) grade relative to pre-treatment) within 6 months of initiation of study intervention and it has CTCAE Grade 3 or 4 recorded within this timeframe.

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
AstraZeneca

1,285 total trials

What the registry record for NCT05943106 still lists

NCT05943106 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 223-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (55% lower).

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 lists 19 locations in 16 states (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.

Learn More About Clinical Trials

Similar trials for Non-muscle Invasive Bladder Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05943106's enrollment target sits among peer trials

100 17th of 30 higher than 14 of 30 other Non-muscle Invasive Bladder Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-muscle Invasive Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05943106, the US trial registry maintained by the National Library of Medicine. NCT05943106 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.