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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.
Must not have
Live attenuated vaccination administered within 30 days prior to enrollment or within 30 days of receiving durvalumab.
Any immune-related adverse event that required biologic agents such as infliximab, or mycophenolate motefil to manage.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I stopped immunotherapy due to side effects, which are now mild or gone, and I finished steroids over 28 days ago.
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My disease is confirmed by tests done within the last 28 days, or 35 days if tests were negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received a live vaccine within 30 days before joining or before getting durvalumab.
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I needed special medication to manage side effects from immune therapy.
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I have an active stomach ulcer or inflammation.
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I have not had severe immune-related side effects from previous treatments.
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I am not currently taking any experimental drugs or cancer treatments.
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My heart condition is stable, and if I have a history of heart issues, my heart's pumping ability is good.
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I have brain metastases that haven't been treated or need surgery/radiation.
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I do not have an active infection needing treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Substudy A: Number and severity of adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
4,427 Previous Clinical Trials
289,164,535 Total Patients Enrolled
Canadian Cancer Trials GroupLead Sponsor
132 Previous Clinical Trials
69,807 Total Patients Enrolled
Peter EllisStudy ChairJuravinski Cancer Centre at Hamilton Health Sciences Centre, Hamilton, ON Canada
Sara K TaylorStudy ChairBCCA-Cancer Centre for the Southern Interior, Kelowna, BC Canada

Media Library

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03847649 — Phase 2
Cancer Research Study Groups: Cohort 2: Standard Risk - Arm A, Cohort 1: High Risk, Cohort 2: Standard Risk - Arm B
Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03847649 — Phase 2
Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03847649 — Phase 2
~32 spots leftby Apr 2030
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