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
- Conditions
- Patients with histologically or cytologically documented muscle-invasive transitional cell carcinoma (TCC) of the bladderTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-510015-19-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1055
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;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.
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
- Secondary Outcome Measures
Name Time Method