Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC - NIAGARA
Study identifier:D933RC00001
ClinicalTrials.gov identifier:NCT03732677
EudraCT identifier:2018-001811-59
CTIS identifier:2023-510015-19-00
Recruitment Complete
Official Title
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.
Medical condition
Muscle invasive bladder cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Durvalumab, Cisplatin, Gemcitabine
Sex
All
Actual Enrollment
1063
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 16 Nov 2018
Estimated Primary Completion Date: 30 Jun 2025
Estimated Study Completion Date: 30 Jun 2026
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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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 |
