NCT03768570

Trimodality Therapy With/Out Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer

A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab to Treat Patients With Muscle-Invasive Bladder Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out what effects durvalumab has on bladder cancer, combined with treatment after completion of surgery, chemotherapy and radiotherapy.

Detailed description

This study is looking at whether a type of immunotherapy drug called durvalumab can be safely administered after initial treatment received by a patient. Durvalumab has been tested in many different types of cancers. Durvalumab works by allowing the immune system to detect cancer and reactivate the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. It is unclear if the addition of durvalumab is beneficial in patients with bladder cancer who have completed surgery, radiotherapy and chemotherapy.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	1500 mg IV on day 1 of 4 week cycle every 4 weeks for 12 months

Timeline

• Start date: 2019-10-25
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2018-12-07
• Last updated: 2026-02-02

Locations

31 sites across 3 countries: Canada, Spain, United Kingdom