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Durvalumab for Bladder Cancer
Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage T2-T4a N0M0 at time of diagnosis based on trans-urethral resection of bladder tumour, imaging, and/or bimanual examination under anesthesia.
Patients must have an estimated creatinine clearance (Cockcroft-Gault Equation) ≥ 30 ml/min.
Must not have
Live attenuated vaccination administered within 30 days prior to randomization.
Received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-PD-L1, including durvalumab anti-programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumour Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if adding durvalumab to standard treatment can improve outcomes for patients with bladder cancer.
Who is the study for?
Adults over 18 with muscle-invasive bladder cancer, who've completed surgery, chemo, and radiotherapy can join this trial. They should have no metastatic disease, a life expectancy over 6 months, good organ function, and be within certain weight and health status limits. Women/men of childbearing potential must agree to use effective contraception for 3 months post-treatment.
What is being tested?
The study is testing the effects of Durvalumab on bladder cancer when given after trimodality therapy (TMT), which includes surgery, chemotherapy, and radiation therapy. The goal is to see if adding Durvalumab improves outcomes compared to just TMT alone.
What are the potential side effects?
Durvalumab may cause immune-related side effects such as inflammation in various organs like lungs or intestines (pneumonitis or colitis), skin reactions (rash), hormone gland problems (thyroid issues), fatigue, infusion reactions during administration of the drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder cancer was between stages T2 to T4a without spread to lymph nodes or distant organs at diagnosis.
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My kidneys work well enough to clear at least 30 ml/min of creatinine.
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I am 18 years old or older.
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My recent scans show no signs of cancer spread.
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My liver functions within normal limits, or slightly above if I have Gilbert's syndrome.
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I agree to provide a sample of my tumor for analysis.
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I have had surgery to remove bladder tissue through the urethra.
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My blood counts meet the required levels for treatment.
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I can care for myself, weigh more than 30kg, and have some ability to move around.
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My bladder cancer diagnosis includes urothelial carcinoma, not purely small cell carcinoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not received a live vaccine in the last 30 days.
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I have been treated with specific immune system targeting drugs before.
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I have received carboplatin-based therapy before.
Select...
I have moderate to severe numbness, tingling, or pain in my hands or feet.
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I have never had a severe reaction to immune therapy or been on recent immunosuppressants.
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My heart's electrical activity (QTcF) is normal or I don't have a family history of long QT syndrome.
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I have a history of lung conditions like pneumonitis or pulmonary fibrosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease
Secondary study objectives
Cost-effectiveness between study arms
Cost-utility between study arms
Upper arm
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: SurveillanceActive Control1 Intervention
Group II: DurvalumabActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
132 Previous Clinical Trials
69,785 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,411 Previous Clinical Trials
289,122,990 Total Patients Enrolled
Wassim KassoufStudy ChairThe Research Institute of the McGill University, Montreal QC Canada
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I have been treated with specific immune system targeting drugs before.My bladder cancer was between stages T2 to T4a without spread to lymph nodes or distant organs at diagnosis.My kidneys work well enough to clear at least 30 ml/min of creatinine.I haven't had serious autoimmune or inflammatory disorders in the last 3 years.I've had up to 4 rounds of specific chemo before surgery but no chemo after surgery.I have received carboplatin-based therapy before.I am 18 years old or older.I have another cancer type, but it won't affect this cancer treatment's safety or results.I have moderate to severe numbness, tingling, or pain in my hands or feet.My recent scans show no signs of cancer spread.I have never had a severe reaction to immune therapy or been on recent immunosuppressants.My liver functions within normal limits, or slightly above if I have Gilbert's syndrome.I am eligible for specific radiotherapy techniques and doses for my treatment.I agree to provide a sample of my tumor for analysis.I finished my surgery, chemotherapy, and radiation therapy less than 42 days ago.I have had surgery to remove bladder tissue through the urethra.My blood counts meet the required levels for treatment.I can care for myself, weigh more than 30kg, and have some ability to move around.My heart's electrical activity (QTcF) is normal or I don't have a family history of long QT syndrome.I do not have any uncontrolled illnesses or infections.I agree to use effective birth control during and for 3 months after treatment.I do not have any health conditions that would prevent me from receiving treatment.I do not have any health conditions that would make the treatment unsafe for me.I can and will complete life quality surveys in English, French, or Spanish.I haven't taken strong immune-suppressing drugs in the last 28 days, except for low-dose or specific types allowed.I have a history of lung conditions like pneumonitis or pulmonary fibrosis.My bladder cancer diagnosis includes urothelial carcinoma, not purely small cell carcinoma.
Research Study Groups:
This trial has the following groups:- Group 1: Surveillance
- Group 2: Durvalumab
Awards:
This trial has 1 awards, including:- 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.