Durvalumab for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+30 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Canadian Cancer Trials Group

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18 with muscle-invasive bladder cancer, who've completed surgery, chemo, and radiotherapy can join this trial. They should have no metastatic disease, a life expectancy over 6 months, good organ function, and be within certain weight and health status limits. Women/men of childbearing potential must agree to use effective contraception for 3 months post-treatment.

Inclusion Criteria

Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits placed on patients being considered for this trial.

Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.

My bladder cancer was between stages T2 to T4a without spread to lymph nodes or distant organs at diagnosis.

+17 more

Exclusion Criteria

I have not received a live vaccine in the last 30 days.

I have been treated with specific immune system targeting drugs before.

I haven't had serious autoimmune or inflammatory disorders in the last 3 years.

+12 more

Participant Groups

The study is testing the effects of Durvalumab on bladder cancer when given after trimodality therapy (TMT), which includes surgery, chemotherapy, and radiation therapy. The goal is to see if adding Durvalumab improves outcomes compared to just TMT alone.

2Treatment groups

Active Control

Group I: SurveillanceActive Control1 Intervention

Group II: DurvalumabActive Control1 Intervention