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Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer

NCT03528694 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1018

Last updated 2026-04-14

No results posted yet for this study

Summary

This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer

Conditions

  • Non-muscle-invasive Bladder Cancer

Interventions

BIOLOGICAL

Durvalumab (MEDI4736)

Investigational product

BIOLOGICAL

Bacillus Calmette-Guerin (BCG)

Standard of care

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2025-04-03
Completion
2028-10-03
FDA Drug
Yes

Countries

  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03528694 on ClinicalTrials.gov