Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bladder Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Safety run-in of 6 patients, followed by two-stage Fleming phase II designMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 prio...
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.
Tracking Information
- NCT #
- NCT04543110
- Collaborators
- Cross Cancer Institute
- Hamilton Health Sciences Corporation
- London Health Sciences Centre
- Ontario Institute for Cancer Research
- AstraZeneca
- Ozmosis Research Inc.
- Investigators
- Principal Investigator: Michael Ong, MD Ottawa Hospital Research Institute Principal Investigator: Naveen Basappa, MD Cross Cancer Institute
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