Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
Phase 3
Active, not recruiting
NCT03732677
| Condition | Muscle Invasive Bladder Cancer |
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| Phase | Phase 3 |
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| Sponsor | AstraZeneca |
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| Status | Active, not recruiting |
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| Enrollment | 1,063 participants |
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| Interventions | Durvalumab, Cisplatin, Gemcitabine |
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| Start date | Nov 16, 2018 |
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| Completion date | Apr 29, 2024 |
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| Results posted | Jul 3, 2025 |
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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
Pathologic Complete Response (pCR) Rates at Time of Cystectomy
Up to 6 months · Participants
| Durvalumab + Gemcitabine + Cisplatin | 199 Participants |
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| Gemcitabine + Cisplatin | 146 Participants |
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| p-value | 0.0005 |
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| Odds Ratio (OR) | 1.60 (95% CI 1.227–2.084) |
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Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event
Up to 48 months · months
| Durvalumab + Gemcitabine + Cisplatin | NA months |
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| Gemcitabine + Cisplatin | 46.1 months |
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| p-value | <0.0001 |
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| Hazard Ratio (HR) | 0.68 (95% CI 0.554–0824) |
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Open in BENITIONS
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