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Checkpoint Inhibitor
Durvalumab (+/- Tremelimumab) for Cancer
Phase 2
Recruiting
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
Absolute neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 90 g/L Bilirubin ≤ 1.5 x ULN (upper limit of normal) AST and ALT ≤ 2.5 x ULN - ≤ 5.0 x ULN (if patient has liver metastases) Serum creatinine < 1.25 x ULN or Creatinine clearance ≥ 40 mL/min
Patients must have previously discontinued immunotherapy due to an irAE. Immune-related adverse events must have resolved to ≤ grade 1 or baseline and patient must have completed corticosteroid therapy at least 28 days prior to registration in this current study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing the effects of durvalumab on cancer. It is also testing if prednisone, given with durvalumab, can reduce any side effects.
Who is the study for?
This trial is for cancer patients in Canada who had a positive response to initial immunotherapy but stopped due to immune-related side effects, which have since resolved. They must not have received certain other treatments post-immunotherapy and should be stable enough with a life expectancy of at least 12 weeks.Check my eligibility
What is being tested?
The study tests the effect of Durvalumab on cancer, alone or with Tremelimumab, after prior checkpoint therapy was discontinued due to toxicity. It also examines if Prednisone can reduce side effects when combined with Durvalumab.See study design
What are the potential side effects?
Potential side effects include immune system reactions that may affect organs, infusion-related responses, increased risk of infections, and possible complications for those with diabetes or heart conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I stopped immunotherapy due to side effects, which are now mild or gone, and I finished steroids over 28 days ago.
Select...
My disease is confirmed by tests done within the last 28 days, or 35 days if tests were negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Substudy A: Number and severity of adverse events
Substudy B: Number and severity of adverse events
Substudy B: To facilitate continued treatment with durvalumab (+/- Tremelimumab) for patients currently enrolled on completed CCTG trials
Secondary outcome measures
Substudy A: Efficacy of corticosteroids in preventing recurrent or new grade 2 or higher irAEs as estimated by the percentages of patients who received corticosteroids and developed recurrent or new grade 2 or higher irAEs
Substudy A: Objective response rate iRECIST
Substudy A:Objective response rate RECIST 1.1
Trial Design
3Treatment groups
Active Control
Group I: Cohort 2: Standard Risk - Arm AActive Control2 Interventions
Group II: Cohort 1: High RiskActive Control2 Interventions
Group III: Cohort 2: Standard Risk - Arm BActive Control2 Interventions
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,268 Previous Clinical Trials
288,612,418 Total Patients Enrolled
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,393 Total Patients Enrolled
Sara K TaylorStudy ChairBCCA-Cancer Centre for the Southern Interior, Kelowna, BC Canada
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I stopped immunotherapy due to side effects, which are now mild or gone, and I finished steroids over 28 days ago.I have not received a live vaccine within 30 days before joining or before getting durvalumab.I will not donate blood during or for 3 months after the study.My cancer responded well to initial immunotherapy and I haven't had immunotherapy for at least 6 months.I've had treatments like chemotherapy or targeted therapy after stopping immunotherapy due to side effects, but no more immune therapies.I have given permission to use my tumor samples for research.I needed special medication to manage side effects from immune therapy.It's been over 4 weeks since my last major surgery and my wounds have healed.I have an active stomach ulcer or inflammation.I have not had severe immune-related side effects from previous treatments.I am not currently taking any experimental drugs or cancer treatments.I had radiation therapy but it ended at least 4 weeks ago.My cancer progressed on initial immunotherapy but didn't worsen quickly after stopping it.I have diabetes, it's under control, and I'm aware of the risks related to immune system-related pancreatic issues.My disease is confirmed by tests done within the last 28 days, or 35 days if tests were negative.My heart condition is stable, and if I have a history of heart issues, my heart's pumping ability is good.I have recovered from side effects of my previous cancer treatments.I live in Canada and have been treated with durvalumab, with or without other therapies.I have brain metastases that haven't been treated or need surgery/radiation.I have not had an organ transplant or used immunosuppressants in the last 28 days.I do not have an active infection needing treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2: Standard Risk - Arm A
- Group 2: Cohort 1: High Risk
- Group 3: Cohort 2: Standard Risk - Arm B
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 kinds of risks do participants in Cohort 2: Standard Risk - Arm A face?
"A score of 2 was assigned to Cohort 2: Standard Risk - Arm A as there is extant evidence validating its safety but none indicating efficacy at this stage in the trial."
Answered by AI
How many individuals are receiving treatment through this investigation?
"The clinical trial necessitates 60 qualified patients to be enrolled, and is being managed by AstraZeneca from various locations; the CHU de Quebec-Hopital l'Enfant-Jesus (HEJ) in Quebec City, Quebec and Grand River Regional Cancer Centre in Kitchener, Ontario are two such sites."
Answered by AI
Are there still vacancies available in this research endeavor?
"As of this moment, according to the data found on clinicaltrials.gov, enrolment for this medical trial is open. It first became available to potential participants in June 2019 and has had its parameters updated most recently in November 2022."
Answered by AI
What maladies are addressed by Cohort 2: Standard Risk - Arm A?
"Patients suffering from lupus erythematosus, thyroiditis, or ulcerative colitis can look to Cohort 2: Standard Risk - Arm A for medical management."
Answered by AI
What other experiments have been conducted regarding Cohort 2: Standard Risk - Arm A?
"Cohort 2: Standard Risk - Arm A has been studied since 2001 at Providence Cancer Center and Providence Portland Medical Centre. Up until now, 708 trials have already been completed while 666 are still active, many of them situated in Quebec City."
Answered by AI
Are there multiple sites offering access to this clinical trial?
"This trial is taking place at CHU de Quebec-Hopital l'Enfant-Jesus (HEJ) in Quebec City, Grand River Regional Cancer Centre in Kitchener, and Regional Health Authority B, Zone 2 in Saint John. Additionally, there are 12 other sites that are participating."
Answered by AI
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