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: 20.0Level: PTClassification code 10005010Term: Bladder cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: 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-ES
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-18
• Last Update Posted: 8 January 2024

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 T2N0M0-T4aN0M0 with 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 involvement or metastatic 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