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

Recruiting now · Phase 2

Conditions studied: Cancer

In brief

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)

Key facts

Study ID

NCT03847649

Run by

Canadian Cancer Trials Group

People needed

60

Starts

2020-03-09

Expected to finish

2031-04-30

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• In general, patients with prior grade 4 non-hematological, non-endocrine immune-related adverse events are not eligible.
• History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of enrollment.
• Live attenuated vaccination administered within 30 days prior to enrollment or within 30 days of receiving durvalumab.
• History of hypersensitivity to durvalumab or any excipient.
• Any immune-related adverse event that required biologic agents such as infliximab, or mycophenolate motefil to manage.
• Documented progressive disease (PD) while on initial immunotherapy. Exception: patients who had iUPD but continued on immunotherapy, and did not have documented iCPD within 8 weeks of discontinuing immunotherapy
• Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF ≥ 50%.
• Concurrent treatment with other investigational drugs or anti-cancer therapy.
• Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (including corticosteroid administration), or would put the patient at risk. This includes but is not limited to:
• History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.
• Active infection requiring systemic therapy; (including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or tuberculosis or any infection requiring systemic therapy).
• Active peptic ulcer disease or gastritis.
• Untreated symptomatic brain metastases or brain metastases in whom radiation or surgery is indicated.
• Patients with diabetes mellitus are eligible but must be clinically stable on therapy (if applicable) and investigator and patient should be aware of the potential risk of immune mediated pancreatic toxicity and B cell destruction.
• Pregnant or lactating women
• Substudy B: Inclusion Criteria
• Patients must be currently enrolled and receiving active treatment on a treatment arm containing durvalumab +/- tremelimumab with or without maintenance pemetrexed with no contraindications to continue receiving their current study regimen according to the protocol to which the patient is currently enrolled.
• For BR.34 ONLY: patients who have disease progression (iUPD) on durvalumab may receive one dose of tremelimumab (75 mg) along with their next durvalumab infusion as long as all the following criteria are met:
• Patient is clinically stable
• According to the judgement of the treating physician, the patient had clinical benefit while receiving tremelimumab in the induction phase on BR.34
• ECOG performance status of 0 or 1
• Laboratory values meet the criteria below:
• 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 (if liver metastases are present, ≤ 5.0 x ULN) Serum creatinine < 1.25 x ULN or Creatinine clearance ≥ 45 mL/min

Where it is running

• Cross Cancer Institute — Edmonton, Alberta, Canada (enrolling)
• BCCA - Kelowna — Kelowna, British Columbia, Canada (enrolling)
• BCCA - Vancouver — Vancouver, British Columbia, Canada (enrolling)
• Regional Health Authority B, Zone 2 — Saint John, New Brunswick, Canada (enrolling)
• Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada (enrolling)
• Waterloo Regional Health Network (WRHN) — Kitchener, Ontario, Canada (enrolling)
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (enrolling)
• University Health Network — Toronto, Ontario, Canada (enrolling)
• Windsor Regional Cancer Centre — Windsor, Ontario, Canada (enrolling)
• CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada (enrolling)
• Saskatoon Cancer Centre — Saskatoon, Saskatchewan, Canada (enrolling)

Full record on ClinicalTrials.gov

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