Trials / Active Not Recruiting
Active Not RecruitingNCT03732677
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
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.
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,063 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
Summary
A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab | Anti- PD-L1 Antibody |
| DRUG | Cisplatin | Chemotherapy Agent |
| DRUG | Gemcitabine | Chemotherapy agent |
Timeline
- Start date
- 2018-11-16
- Primary completion
- 2024-04-29
- Completion
- 2026-06-30
- First posted
- 2018-11-06
- Last updated
- 2026-03-13
- Results posted
- 2025-07-03
Locations
188 sites across 22 countries: United States, Australia, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Israel, Italy, Japan, Netherlands, Philippines, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03732677. Inclusion in this directory is not an endorsement.