Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin

• Status: Recruiting
• Trial end date: 2028-09-08
• Target enrollment: 0
• Participant gender: All

Summary

A Global Study to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Durvalumab; Tremelimumab

Criteria

Inclusion Criteria:

• Histologically or cytologically documented muscle-invasive TCC of the bladder with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology;

• Medically fit for cystectomy and able to receive neoadjuvant therapy;

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

• ECOG performance status of 0,1,2 at enrollment.

• Availability of tumor sample prior to study entry;

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

Exclusion criteria:

• Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening.

• Active infection

• Uncontrolled intercurrent illness

• 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 IPs.