This is a 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.

Phase 1

Conditions: Patients with histologically or cytologically documented muscle-invasive transitional cell carcinoma (TCC) of the bladder.
MedDRA version: 21.0Level: PTClassification code 10005010Term: Bladder cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.0Level: PTClassification code 10005011Term: Bladder cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2018-001811-59-IT

Lead Sponsor: ASTRAZENECA AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1050

Inclusion Criteria

Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology;

Patients must be planning to undergo a radical cystectomy at the time of randomization;

Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC;

ECOG performance status of 0 or 1 at enrollment.

Availability of tumor sample prior to study entry;

Must have a life expectancy of at least 12 weeks at randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 525
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 525

Exclusion Criteria

Evidence of lymph node (N2-N3) involvement or metastatic (M1) disease at the time of screening.

Contra-indication to any of the study drugs

Requires immunosuppression medication for a concomitant condition

Active or prior documented autoimmune or inflammatory disorders

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess efficacy of investigational product in patients with MIBC using pCR and EFS;Secondary Objective: To assess efficacy and safety of investigational product in patients with MIBC using the following:<br>EFS, pCR, EFS24<br>Proportion of patients who achieve <P2<br>Proportion of subjects with cystectomy<br>Metastasis-free survival and disease-specific survival<br>OS<br>DFS<br>Pharmacokinetic and Immunogenicity<br>Safety and tolerability profile;Primary end point(s): pCR<br>EFS;Timepoint(s) of evaluation of this end point: Approximately 6 months (pCR)<br>Up to 48 months (EFS)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): EFS, pCR, EFS24<br>Proportion of patients who achieve <P2<br>Proportion of subjects with cystectomy<br>Metastasis-free survival and disease-specific survival<br>OS<br>DFS<br>Pharmacokinetic and Immunogenicity<br>Safety and tolerability profile;Timepoint(s) of evaluation of this end point: Approximately 6 months (pCR; Proportion of patients who achieve <P2)<br>Up to 24 months (EFS24)<br>Up to 84 months (OS; Safety and tolerability profile)<br>Up to 48 months (Other endpoints)

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