NCT04543110

Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma
RADIATION	Immune Modulating Radiation	Neoadjuvant Immune-Modulating Radiation prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma

Timeline

• Start date: 2021-01-29
• Primary completion: 2023-10-01
• Completion: 2024-11-01
• First posted: 2020-09-09
• Last updated: 2023-03-23

Locations

4 sites across 1 country: Canada