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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

A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer Patients

NCT03528694•AstraZeneca

View on ClinicalTrials.gov

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

Detailed Description

Patients will be randomized in a 1:1:1 ratio to receive treatment with Durvalumab + BCG combination therapies, or Standard of Care (SoC) therapy.

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged at least 18 years
•BCG-naïve (patients who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry are eligible)
•Local histological confirmation (based on pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high risk tumor is defined as one of the following
•* T1 tumor
•* High grade/ G3 tumor
•* CIS
•* Multiple and recurrent and large (with diameter of largest tumor ≥3 cm) tumors (all conditions must be met in this point)
•Complete resection of all Ta/T1 papillary disease prior to randomization, with the TURBT removing high-risk NMIBC performed not more than 4 months before randomization in the study. Patients with residual CIS after TURBT are eligible
•No prior radiotherapy for bladder cancer
•No prior exposure to immune-mediated therapy of cancer including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 antibodies. Patients who have been treated with anticancer vaccines will be excluded

Exclusion Criteria

•Evidence of muscle-invasive, locally advanced, metastatic, and/or extra vesical bladder cancer (ie, T2, T3, T4, and / or stage IV)
•Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive transitional cell carcinoma of the urothelium
•Previous investigational product (IP) assignment in the present study
•Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer related conditions (eg, hormone replacement therapy) is acceptable. Chemotherapy for previous instances of NMIBC is acceptable.
•Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
•* Patients with vitiligo or alopecia
•* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
•* Any chronic skin condition that does not require systemic therapy
•* Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician
•* Patients with celiac disease controlled by diet alone
+9 more criteria

Locations (120)

Research Site

Auchenflower, Australia

Research Site

Box Hill, Australia

Research Site

Brisbane, Australia

Research Site

Kogarah, Australia

Research Site

Orange, Australia

Research Site

Parkville, Australia

Research Site

Westmead, Australia

Research Site

Wollongong, Australia

Research Site

Graz, Austria

Research Site

Innsbruck, Austria

Key Dates

Start Date

May 14, 2018

Primary Completion Date

April 3, 2025

Completion Date

October 3, 2028

Last Updated

November 25, 2025

Enrollment

1,018

ACTUAL participants

Conditions

Non-muscle-invasive Bladder Cancer

Interventions

Durvalumab (MEDI4736)

BIOLOGICAL

Bacillus Calmette-Guerin (BCG)

BIOLOGICAL

Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

NCT06567743

High-Risk Non-Muscle-Invasive Bladder Cancer

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RECRUITINGNA

Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study

NCT07339761

Bladder CancerNon-Muscle-Invasive Bladder Cancer (NMIBC)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study

A Phase I Intravesical PPM Therapy for NMIBC

A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy

Safety and Efficacy of Scheduled Intravesical Gemcitabine Versus Intravesical BCG for Intermediate and High Risk Non Muscle Invasive Bladder Cancer: A Prospective, Randomized Study

Blue Laser -5ala Photodynamic Therapy (PDT) in High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients