Clinical Trial

Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)

Recruiting Phase 3
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Summary
The Phase IIIb NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with investigator-selected cisplatin-based neoadjuvant chemotherapy (either ddMVAC or gemcitabine/cisplatin) in a clinical practice setting.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2025-04-29; most recent amendment 2026-06-10.
Status change: Not Yet Recruiting → Recruiting 2025-05-23
Trial Details
NCT Number NCT06960577
Lead Sponsor AstraZeneca
Conditions Urinary Bladder Neoplasms, Immune Checkpoint Inhibitors, Methotrexate, Vinblastine, Doxorubicin, Cisplatin, Gemcitabine
Enrollment 150 participants
Start Date 2025-05-15
Primary Completion 2028-10-31 (estimated)
Study Completion 2028-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-04