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Checkpoint Inhibitor
Tremelimumab for Bladder Cancer (Rideau Trial)
Phase 1 & 2
Waitlist Available
Led By Peter Black
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Summary
This trial will test whether a local injection of tremelimumab into the bladder wall, in combination with systemic administration of durvalumab, will stimulate an effective anti-tumour immune response with minimal clinical toxicity.
Eligible Conditions
- Bladder Cancer
- Cancer
- Tremelimumab
- Durvalumab
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with grade 3 adverse events related to tremelimumab
Secondary study objectives
Complete pathological response
Other study objectives
Cytokine profiling
Immune cell analysis from whole blood sample
Cell-Free DNA
Side effects data
From 2019 Phase 2 trial • 33 Patients • NCT0300740738%
Fatigue
21%
Diarrhea
17%
Nausea
17%
Fever
17%
Anorexia
17%
Maculopapular rash
17%
Pruritus
14%
Constipation
14%
Rash maculo-papular
10%
Anemia
10%
Abdominal pain
10%
Itching
7%
Hypothyroidism
7%
Non-cardiac chest pain
7%
Weight loss
7%
Cough
7%
Dry Skin
7%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: TremelimumabExperimental Treatment1 Intervention
Patients who will receive local cystoscopic injection of tremelimumab into the bladder wall in combination with systemic administration of durvalumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3130
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,451 Previous Clinical Trials
2,483,190 Total Patients Enrolled
Peter BlackPrincipal InvestigatorUniversity of British Columbia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be planning to have your bladder completely removed at the hospital where the trial is taking place.If you had bladder cancer that spread to your kidneys or ureters within the last two years, you can only participate if it was a small cancer and you had surgery to remove the affected area.You have not responded well to BCG therapy.You are expected to live for at least 1 year.You have received radiation treatment for bladder cancer in the past.You have an ongoing or previous autoimmune or inflammatory condition that has been diagnosed by a doctor.You have a serious medical condition that is not being managed or controlled.You have had cancer before, except in certain cases.You received a live vaccine within 30 days before the first dose of the study drug.You are allergic or hypersensitive to any of the study drugs or their ingredients.You have previously participated in a clinical trial that involved durvalumab and/or tremelimumab.You have a condition that blocks the normal flow of urine or prevents the injection of tremelimumab during cystoscopy.This is not an actual criterion, but rather a header for a specific phase of the trial called "Dose Expansion Phase."Criteria related to your medical condition.This is a specific phase of the clinical trial called "dose escalation."You have a confirmed diagnosis of bladder cancer that has come back and is still in the bladder, within the last 60 days before joining the study.You have a type of cancer called pure squamous carcinoma in situ.You can participate in the study if you have had surgery to remove bladder tumors that are in the early stages (Ta or T1) within the last 60 days. However, if you have CIS disease, which is expected to be not completely removed, you cannot participate in the study.You had a recent exam called cystoscopy to check for visible signs of a tumor in your bladder, and there were no tumors found. If you had a bladder biopsy or TURBT within the last 21 days, it will also fulfill this requirement.You have bladder cancer confirmed by a biopsy or a surgery called transurethral bladder tumour resection within the last 120 days.The study doctor needs to review a sample of your cancer tissue. This can be done after you start the study treatment.Can you please provide more information on the specific disease related criteria you would like me to summarize?You are currently receiving chemotherapy, biologic therapy, hormonal therapy, or a treatment called IP for your cancer.You have received a transplant of bone marrow or an organ from someone else in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Tremelimumab
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.
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