Phase IIIb Study of Durvalumab with Neoadjuvant ddMVAC or GemcitabineCisplatin Before Radical Cystectomy in Muscle-invasive Bladder Cancer

What this Trial Is About

This research aims to evaluate the use of perioperative durvalumab combined with investigator-selected cisplatin-based neoadjuvant chemotherapy regimens ddMVAC or gemcitabinecisplatin for patients with muscle-invasive bladder cancer scheduled to undergo radical cystectomy. It builds upon prior Phase III data to explore this treatment combination in a clinical practice setting and focuses on treatment safety and efficacy. The study is sponsored by AstraZeneca and is a Phase IIIb trial. Participants will receive durvalumab alongside one of two chemotherapy options ddMVAC or gemcitabinecisplatin, selected by the investigator. The treatments are given before surgery neoadjuvant in preparation for radical cystectomy. The study includes two experimental cohorts corresponding to the chemotherapy regimens combined with durvalumab. The treatment period includes perioperative administration and follows up after surgery. Throughout the study, participants will be monitored for safety and tolerability of the combined treatment up to 6 months initially and up to 2 years for extended safety assessments. Researchers will also evaluate efficacy outcomes such as event-free survival, disease-free survival, overall survival, and pathological responses up to 3 years. The total participation time spans several years to capture these outcomes, with regular assessments including clinical evaluations and monitoring for adverse effects.

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