Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

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Antineoplastic Agents

Immunomodulating Agents

Durvalumab

Antineoplastic Agents, Immunological

Immune-Modulating Radiation with Durvalumab prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma

Durvalumab prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma

Neoadjuvant Immune-Modulating Radiation prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma

Immune Modulating Radiation

Michael Ong, MD

Naveen Basappa

Aly-Khan Lalani

Ricardo Fernandes, MD

Caroline Proulx

Naveen Basappa, MD

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

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.

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)

Qualified researchers can contact Dr. Michael Ong regarding sharing of data and be evaluated for what their purpose and plan is for the data.

pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed using specimens obtained post radical cystectomy following the study intervention.

Adverse events related to the study treatment will be identified and characterized using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. A copy of the CTCAE version 5.0 can be downloaded from the Cancer Therapy Evaluation Program website (http://ctep.cancer.gov). Data will be collected from time of confirmed study entry

Feasibility. Surgery is expected to occur within 90 days of radiotherapy. Any delay beyond that will be noted and the cause of the delay attributed to study intervention or otherwise, with supporting details.

Proportion of patients who have pathological staging \<T2 as determined after radical cystectomy.

he proportion of patients who have radiographically confirmed recurrence of their cancer at 1 and 2 years. Time to recurrence is defined from the time of study entry to the first recurrence of disease after cystectomy. A recurrence of disease includes local (pelvic) recurrence, urinary tract recurrence, or distant metastases of urothelial carcinoma. Recurrence rate will be assessed using computed tomography (CT)/magnetic resonance imaging (MRI) and/or Positron Emission Tomography (PET)-CT (per standard local imaging practices) and pathology testing performed according to local standards and as clinically indicated.

The proportion of patients who are alive at 1 and 2 years. Overall survival is defined from the date of study entry until death of any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC	NCT04543110	Bladder Cancer	Durvalumab Immune Modulati...	18 Years -	Ottawa Hospital Research Institute
Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC	NCT04543110	Bladder Cancer	Durvalumab Immune Modulati...	18 Years -	Ottawa Hospital Research Institute

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