Condition: Urinary Bladder Neoplasms, Immune Checkpoint Inhibitors, Methotrexate, Vinblastine, Doxorubicin, Cisplatin, Gemcitabine

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06960577

Sponsor: AstraZeneca

Phase: Phase 3

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Participants with clinical tumour stage T2-T4aN0/1M0 or T1N1M0 with transitional or mixed transitional cell histology
• Patients must be planning to undergo radical cystectomy
• Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer
• ECOG performance status of 0 or 1
• Minimum life expectancy of 12 weeks at first dose of study medication

Exclusion Criteria:

• Evidence of lymph node (N2-N3) or metastatic (M1) disease
• Inoperable tumour(s) with fixation to the pelvic wall on clinical examination
• Prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD 1, anti-PD L1 and anti-PD-L2 antibodies, excluding Bacillus Calmette-Guérin
• Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab
• Any concomitant medication known to be contraindicated to the chemotherapy (ddMVAC or gem/cis).
• Uncontrolled intercurrent illness.

View trial on ClinicalTrials.gov