Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

Official Title

A Phase III, Randomized, Open-Label, Multi-Centre, 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.

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

Trial Description

Primary Outcome:

• Pathologic complete response (pCR) rates at time of cystectomy
• Event-free survival (EFS) per central review defined as time from randomization to event

• Proportion of patients who achieve
• EFS at 24 months (EFS24) defined as time from randomization to event
• Proportion of patients who undergo cystectomy
• Overall survival rate at 5 years
• PFS2 defined as time from randomization to event following subsequent therapy
• Safety and Tolerability as evaluated by adverse events occurring throughout the study
• Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA)

View this trial on ClinicalTrials.gov