Actively Recruiting
A Phase II Study of Durvalumab Treatment - Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity - Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies
Led by Canadian Cancer Trials Group · Updated on 2025-06-11
60
Participants Needed
12
Research Sites
581 weeks
Total Duration
On this page
Sponsors
C
Canadian Cancer Trials Group
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
I238A: The purpose of this study is to find out what effects being treated with durvalumab has on cancer. The researchers doing this study also want to evaluate if prednisone (a type of steroid), when given together with durvalumab, can reduce any side effects. I238B: The purpose of this study is to allow patients previously enrolled on a completed CCTG trial to continue treatment with durvalumab (+/- tremelimumab)
CONDITIONS
Official Title
A Phase II Study of Durvalumab Treatment - Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity - Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have advanced, metastatic, recurrent, or unresectable solid tumors confirmed by biopsy, with no curative therapy available.
- Patients must live in Canada and have received durvalumab alone or with tremelimumab, with or without chemotherapy or targeted therapy.
- Patients must have stopped prior immunotherapy due to immune-related side effects.
- Immune-related side effects must have resolved to grade 1 or baseline, and corticosteroid treatment must have been completed at least 28 days before enrolling.
- Patients must have shown complete or partial response, or stable disease for at least 8 weeks, to initial immunotherapy.
- Patients previously treated with adjuvant/neoadjuvant immunotherapy must have had at least 6 months off treatment and received standard chemotherapy in the palliative setting.
- Patients must have a life expectancy of at least 12 weeks.
- Tumor tissue samples may be required for correlative studies.
- Documented disease must be present, with radiology studies done within 28 days before enrollment.
- ECOG performance status must be 0 or 1.
- Patients may have received other cancer therapies after stopping immunotherapy, except additional checkpoint inhibitors.
- Patients must have recovered from prior therapy side effects and meet specific blood count and organ function levels.
- Prior radiation and surgery must have been completed at least 28 days before enrollment.
- Patients must provide informed consent and be able to attend treatment and follow-up at the study center.
- Treatment must start within 2 working days of enrollment.
- Women and men of childbearing potential must agree to use effective contraception.
- Patients should not donate blood during the study or for 90 days after the last durvalumab infusion.
- For Substudy B, patients must be currently enrolled and actively receiving durvalumab with or without tremelimumab as per their prior trial regimen.
- Specific lab values must meet minimum levels for blood counts and organ function for Substudy B.
You will not qualify if you...
- Patients with prior grade 4 non-hematological, non-endocrine immune-related adverse events are excluded.
- History of primary immunodeficiency or organ transplant requiring immunosuppression within 28 days.
- Live vaccine administration within 30 days before enrollment or durvalumab treatment.
- Known allergy or hypersensitivity to durvalumab or its components.
- Immune-related adverse events requiring biologic agents like infliximab or mycophenolate mofetil.
- Progressive disease during initial immunotherapy, except certain stable exceptions.
- Untreated or symptomatic brain metastases requiring treatment.
- Uncontrolled cardiovascular conditions or significant cardiac history with less than 50% heart function.
- Use of other investigational or anti-cancer drugs concurrently.
- Serious medical illnesses or conditions preventing protocol compliance or increasing risk, including active infection, significant neurological or psychiatric disorders, active peptic ulcers, or uncontrolled diabetes.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
2
BCCA - Kelowna
Kelowna, British Columbia, Canada, V1Y 5L3
Actively Recruiting
3
BCCA - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
4
Regional Health Authority B, Zone 2
Saint John, New Brunswick, Canada, E2L 4L2
Actively Recruiting
5
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
6
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario, Canada, N2G 1G3
Actively Recruiting
7
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
8
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
9
Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Actively Recruiting
10
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
11
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
12
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Actively Recruiting
Research Team
P
Pierre-Olivier Gaudreau
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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