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

Primary Outcome Measures

1. Pathologic Complete Response (pCR) Rates at Time of Cystectomy
   pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed per central pathology review using specimens obtained via radical cystectomy following the neoadjuvant treatment. The denominator for pCR will be the number of patients in the FAS.
2. Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event
   EFS is defined as the time from randomization to the first recurrence of disease post radical cystectomy, time of first documented progression in patients who were medically precluded for radical cystectomy, or time of expected surgery in patients who refuse to undergo a radical cystectomy or failure to undergo a radical cystectomy in participants with residual disease, or the time of death due to any cause, whichever occurs first

Secondary Outcome Measures

1. Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event
   EFS24 is defined as the Kaplan-Meier estimate of EFS at 24 months after randomization, as assessed per blinded independent central review or by central pathology review if a biopsy is required for a suspected new lesion, and per local investigator or local biopsy review if a biopsy is required for a suspected new lesion
2. Proportion of Patients Who Undergo Cystectomy
   The proportion of patients who undergo cystectomy is defined as the proportion patients who undergo radical cystectomy after the neoadjuvant treatment. The denominator will be patients in the FAS.
3. Overall Survival
   OS is defined as the time from the date of randomization until death due to any cause regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy (i.e., date of death or censoring - date of randomization + 1)
4. Metastasis-free Survival Per Investigator Assessment or Local Biopsy Review.
   MFS is defined as the time from date of randomization until the first recognition of distant metastases or death, whichever occurs first
5. Disease-specific Survival Per Investigator Assessment or Local Biopsy Review.
   DSS is defined as the time from the date of randomization until death due to bladder cancer
6. Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA)
   Whole blood samples for assessing ADA for durvalumab in serum were collected from patients undergoing durvalumab treatment, following the specified assessment schedule. ADA prevalence is the proportion of patients with a positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA includes both treatment-induced and treatment-boosted ADA. Its incidence is the proportion of patients with treatment-emergent ADA positivity. Treatment-boosted ADA refers to a baseline-positive ADA titer that increased ≥4-fold during the study. Persistently positive patients have at least two post-baseline ADA-positive readings, with at least 16 weeks between the first and last, or an ADA-positive result at the final assessment. This includes baseline-positive patients meeting these criteria. Transiently positive is defined by at least one post-baseline ADA-positive reading without being persistently positive, including baseline-positive patients meeting these terms.