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

Official Title

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

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 radiation therapy.

Trial Description

Primary Outcome:

• Disease-free survival

Secondary Outcome:

• Non-muscle invasive bladder cancer recurrence rate
• Loco-regional control rate between study arms at the 12 week visit
• Patterns of disease recurrence between study arms
• Compare overall and bladder intact disease-free survival between study arms
• Metastasis-free survival between study arms
• Number and severity of adverse events between study arms
• Quality of Life between treatment arms using Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-BL) questionnaire
• Cost-effectiveness between study arms
• Cost-utility between study arms

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, radiation therapy and chemotherapy.

View this trial on ClinicalTrials.gov