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PD-L1 Inhibitor
Radiation + Durvalumab for Bladder Cancer (RADIANT Trial)
Phase 2
Recruiting
Led By Naveen Basappa, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
ECOG performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
RADIANT Trial Summary
This trial is testing a new way to treat bladder cancer that may be more effective than current methods.
Who is the study for?
Adults over 18 with bladder cancer, specifically transitional cell carcinoma/urothelial carcinoma, who are fit for radiation, immunotherapy with durvalumab, and surgery. They must not have autoimmune diseases or active infections like TB or HIV, no prior TCC/UC treatments or immune therapies (except BCG), and no severe allergies to drug components. Participants should use effective birth control and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing the combination of radiation therapy followed by durvalumab immunotherapy before surgical removal of the bladder in patients with bladder cancer. The goal is to see how well this sequence works as a pre-surgery treatment.See study design
What are the potential side effects?
Durvalumab may cause immune-related reactions affecting various organs, infusion-related symptoms, fatigue, potential infection risks due to weakened immunity, allergic responses specific to its formulation ingredients.
RADIANT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer is confirmed as urothelial carcinoma.
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I weigh more than 30 kilograms.
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I am a woman who can have children and have a negative pregnancy test.
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I can provide a sample of my tumor for testing.
RADIANT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological Complete Response (pCR) Rate
Secondary outcome measures
Adverse events
Overall survival rate at 1 and 2 years
Rate of Pathological Downstaging
+2 moreRADIANT Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 Interventions
Immune-Modulating Radiation with Durvalumab prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Find a Location
Who is running the clinical trial?
Cross Cancer InstituteOTHER
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19,174 Total Patients Enrolled
Ozmosis Research Inc.Industry Sponsor
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am fully active or can carry out light work.My cancer originates from the ureter, urethra, or renal pelvis, not the bladder.My tumor cannot be removed surgically and is attached to the pelvic wall.My bladder cancer has spread to distant parts of my body.I have not had severe infections in the last 4 weeks.I have no health conditions that prevent me from receiving radiation therapy.You have a history of severe allergic reactions to certain types of medications.I am not currently on any cancer treatments like chemotherapy or hormone therapy.I have had treatment for bladder cancer before.My cancer is confirmed as urothelial carcinoma.My blood and organ function tests are within normal ranges.I haven't had any cancer other than bladder cancer in the last 5 years, or if I did, it was not serious and was treated successfully.I have a history of autoimmune or connective tissue disorder.My bladder cancer has specific cell types, including mixed or variant types.My bladder cancer has spread to the pelvic or abdominal wall.You have a history of a weak immune system that you were born with.I am not breastfeeding and will not for 90 days after my last durvalumab dose.I do not have any major health issues that could interfere with the study.I am allergic to certain medications made in Chinese hamster ovary cells.I have not received a live vaccine in the last 30 days.I weigh more than 30 kilograms.I have been treated with immune therapy before, but not BCG.I haven't been in a clinical trial or taken experimental drugs in the last 28 days.I agree not to donate sperm during and up to 3 months after the study.I have been diagnosed with idiopathic pulmonary fibrosis.I am considered medically fit for specific cancer treatments including surgery.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.I am using effective birth control and will continue for 90 days after my last durvalumab dose.I do not have serious heart conditions like recent heart attacks or unstable heart disease.I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.I am a woman who can have children and have a negative pregnancy test.I do not have active infections like TB, hepatitis B, C, or HIV.My scans show a lymph node that might be cancerous and is larger than 10 mm.I haven't taken immunosuppressive drugs in the last 14 days.I am fit and scheduled for bladder removal surgery.My bladder cancer is at a specific stage and has not spread to lymph nodes or other parts of my body.I have had an organ transplant and take drugs to suppress my immune system.I can provide a sample of my tumor for testing.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being recruited to participate in this clinical trial?
"Confirmed, the details on clinicaltrials.gov indicate that this research endeavour is currently recruiting volunteers. This investigation was initially posted in late January 2021 and has since been updated once more in mid-June 2021; it requires 25 individuals to be enrolled from 4 unique locations."
Answered by AI
Are there numerous facilities offering this trial in Canada?
"Potential participants can enroll in the trial at Juravinski Cancer Centre (Hamilton), London Health Sciences Centre (London), The Ottawa Hospital Cancer Centre (Ottawa) and other 4 sites."
Answered by AI
Has the US Food and Drug Administration accepted Durvalumab for medical use?
"Although the efficacy of durvalumab has yet to be assessed, there is sufficient evidence for its safety and thus was awarded a score of 2."
Answered by AI
Are there any openings remaining in this research project?
"According to public records on clinicaltrials.gov, this research is still recruiting participants after being first advertised in late January 2021 and last updated in mid-June of the same year."
Answered by AI
What other research has been undertaken using Durvalumab?
"According to current records, 333 trials are being conducted on Durvalumab. Of those active studies, 52 have reached Phase 3 and the majority of sites for this research lie in Cordoba, Texas; however, there are 12952 clinical trial centres worldwide that offer tests for this drug."
Answered by AI
What illnesses does Durvalumab typically treat effectively?
"Patients with advanced, surgically inoperable stage III non-small lung cancer and metastatic urethral/urothelial carcinoma may be treated using Durvalumab."
Answered by AI
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