Study identifier:D933RC00001
ClinicalTrials.gov identifier:NCT03732677
EudraCT identifier:2018-001811-59
CTIS identifier:2023-510015-19-00
A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer.
Muscle invasive bladder cancer
Phase 3
No
Durvalumab, Cisplatin, Gemcitabine
All
1063
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1 Chemotherapy + Durvalumab | Drug: Durvalumab Anti- PD-L1 Antibody Drug: Cisplatin Chemotherapy Agent Drug: Gemcitabine Chemotherapy agent |
Active Comparator: Arm 2 Chemotherapy alone | Drug: Cisplatin Chemotherapy Agent Drug: Gemcitabine Chemotherapy agent |