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

• Status: Active, not recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

Summary

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antibodies, Monoclonal; Cisplatin; Durvalumab; Gemcitabine

Criteria

Inclusion:

• 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

• Must have a life expectancy of at least 12 weeks at randomization

Exclusion:

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

• Prior pelvic radiotherapy treatment within 2 years of randomization to study

• Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies.

• Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)

• Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.

• Uncontrolled intercurrent illness

• Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency