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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease
Secondary outcome measures
Compare overall and bladder intact disease-free survival between study arms
Cost-effectiveness between study arms
Cost-utility between study arms
+6 moreTrial 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
124 Previous Clinical Trials
67,371 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,259 Previous Clinical Trials
288,593,820 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit of participants in this medical research?
"To meet the standards of this experiment, 190 people who satisfy the set criteria must join. Patients can apply at numerous locations such as The Jewish General Hospital based in Montreal and Stronach Regional Health Centre located in Newmarket."
Answered by AI
Is there a call for volunteers to take part in this trial?
"Clinicaltrials.gov attests that this clinical trial is still in active recruitment phases, having first been posted on December 21st 2018 and most recently modified on November 14th 2022."
Answered by AI
What medical conditions can Durvalumab be deployed to combat?
"Durvalumab is regularly used to treat unresectable stage III non-small cell lung cancer and can also provide relief for those struggling with metastatic ureter urothelial carcinoma or advanced directives."
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Could you provide a synopsis of previous research involving Durvalumab?
"Durvalumab was initially assessed in 2010 at City of Hope, and there have already been 106 completed examinations. At present, 333 ongoing trials are being conducted throughout Montreal, Quebec."
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What potential harms could be caused by utilization of Durvalumab?
"Our judgement of Durvalumab's safety is a 2 as this trial has reached phase two, suggesting that there are some data points to back up its security but no proof yet of efficacy."
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How many locations are currently conducting this research?
"This medical trial is occuring across several centres, including The Jewish General Hospital in Montreal and Stronach Regional Health Centre at Southlake in Newmarket. Additionally, the BCCA - Vancouver Cancer Centre in Vancouver Alberta also provides participation opportunities to interested individuals. Other locations are available as well."
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