NCT03528694

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,018 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-muscle-invasive Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab (MEDI4736)	Investigational product
BIOLOGICAL	Bacillus Calmette-Guerin (BCG)	Standard of care

Timeline

• Start date: 2018-05-14
• Primary completion: 2025-04-03
• Completion: 2028-10-03
• First posted: 2018-05-18
• Last updated: 2026-04-14

Locations

120 sites across 12 countries: Australia, Austria, Belgium, Canada, France, Germany, Japan, Netherlands, Poland, Russia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study