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 following neoadjuvant treatment, as assessed by central pathology review
• Event-free survival (EFS) per central review defined as time from randomization to the first recurrence of disease (after cystectomy), or progression in patients who were precluded for cystectomy, or death due to any cause, whichever occurs first

• Proportion of patients who achieve
• EFS at 24 months (EFS24) defined as time from randomization to the first recurrence of disease (after cystectomy), or first progression in patients who were precluded for cystectomy, or death due to any cause, whichever occurs first
• Proportion of patients who undergo cystectomy
• Overall survival rate at 5 years, as determined based on time from date of randomization to date of death, from any cause
• PFS2 defined as the time from the date of randomization to the earliest date of progression which occurs on subsequent therapy following an EFS event or death
• 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