Study identifier:D419JC00001
ClinicalTrials.gov identifier:NCT03528694
EudraCT identifier:2017-002979-26
CTIS identifier:2023-505341-23-00
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
Non-muscle-invasive bladder cancer
Phase 3
No
-
All
1018
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca
AstraZeneca
-
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
Patients will be randomized in a 1:1:1 ratio to receive treatment with Durvalumab + BCG combination therapies, or Standard of Care (SoC) therapy.
Location
Location
Madrid, Spain, 28040
Location
Madrid, Spain, 28041
Location
Madrid, Spain, 08035
Location
Elche(Alicante), Spain, 03202
Location
Quebec, QC, Canada, G1J 1Z4
Location
Münster, Germany, 48149
Location
Nürtingen, Germany, 72622
Location
Köln, Germany, 50968
Arms | Assigned Interventions |
---|---|
Experimental: Durvalumab plus BCG (induction + maintenance) Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy | Biological/Vaccine: Durvalumab (MEDI4736) Investigational product Biological/Vaccine: Bacillus Calmette-Guerin (BCG) Standard of care |
Experimental: Durvalumab plus BCG (induction only) Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy | Biological/Vaccine: Durvalumab (MEDI4736) Investigational product Biological/Vaccine: Bacillus Calmette-Guerin (BCG) Standard of care |
Active Comparator: BCG treatment (Standard of care therapy) Bacillus Calmette-Guerrin (BCG) standard of care treatment | Biological/Vaccine: Bacillus Calmette-Guerin (BCG) Standard of care |
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