Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC (RADIANT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04543110|
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : June 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Durvalumab Radiation: Immune Modulating Radiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Safety run-in of 6 patients, followed by two-stage Fleming phase II design|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Immune-Modulating Radiation With Durvalumab (MEDI4736) Prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma (RADIANT)|
|Actual Study Start Date :||January 29, 2021|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||November 2024|
Experimental: Single Arm
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
Other Name: (MEDI4736)
Radiation: Immune Modulating Radiation
Neoadjuvant Immune-Modulating Radiation prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma
Other Name: Neoadjuvant Immune Modulating Radiation
- Pathological Complete Response (pCR) Rate [ Time Frame: Up to 2 years ]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 [ Time Frame: Up to 2 years ]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
- Rate of delay of surgery [ Time Frame: Up to 2 years ]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.
- Rate of Pathological Downstaging [ Time Frame: Up to 2 years ]Proportion of patients who have pathological staging <T2 as determined after radical cystectomy.
- Recurrence rates at 1 year and 2 years [ Time Frame: Up to 2 years ]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.
- Overall survival rate at 1 and 2 years [ Time Frame: Up to 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543110
|Contact: Michael Ong, MD||613-737-7700 ext email@example.com|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada|
|Contact: Naveen Basappa|
|Juravinski Cancer Centre||Recruiting|
|Hamilton, Ontario, Canada|
|Contact: Aly-Khan Lalani|
|London Health Sciences Centre||Recruiting|
|London, Ontario, Canada|
|Contact: Ricardo Fernandes, MD|
|The Ottawa Hospital Cancer Centre||Recruiting|
|Ottawa, Ontario, Canada, K1H8L6|
|Contact: Caroline Proulx firstname.lastname@example.org|
|Principal Investigator:||Michael Ong, MD||Ottawa Hospital Research Institute|
|Principal Investigator:||Naveen Basappa, MD||Cross Cancer Institute|