Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC

Official Title

Neoadjuvant Immune-Modulating Radiation With Durvalumab (MEDI4736) Prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma (RADIANT)

Summary:

This study assesses the effect of sequential radiation and durvalumab immunotherapy given as treatment prior to surgery with radical cystectomy for bladder cancer.

Trial Description

Primary Outcome:

• Pathological Complete Response (pCR) Rate

Secondary Outcome:

• Adverse events
• Rate of delay of surgery
• Rate of Pathological Downstaging
• Recurrence rates at 1 year and 2 years
• Overall survival rate at 1 and 2 years

In this phase II study, patients who are either not eligible or declined to have chemotherapy prior to surgery for muscle-invasive bladder cancer may consent and enrol to study. Patients will have single 8 Gy hypofractionated radiation to bladder followed by 3 cycles of durvalumab immunotherapy prior to radical cystectomy. This study will assess the safety and tolerability, pathological and radiological response, and immune biological correlatives to understand the effect of radiation and durvalumab.

View this trial on ClinicalTrials.gov