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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    60
  • sponsor
    Canadian Cancer Trials Group
Updated on 21 October 2022
corticosteroids
tyrosine
prednisone
measurable disease
treatment regimen
x-rays
metastasis
pemetrexed
neutrophil count
liver metastasis
pd-l1
cancer treatment
primary cancer
solid tumour
targeted therapy
solid neoplasm
immunostimulants

Summary

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)

Description

Durvalumab is a new type of drug for many types of cancer. Durvalumab is an immunotherapy drug and not a chemotherapy drug. Laboratory tests show that it works by allowing the immune system (PD-1 and PD-L1 interaction) to detect your cancer and reactivating the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in animals and has been studied in more than 6000 people. This drug seems promising but it is not clear if it can offer better results than standard treatment alone or if people can be re-treated with durvalumab after previous side effects

Details
Condition Cancer
Treatment prednisone, durvalumab
Clinical Study IdentifierNCT03847649
SponsorCanadian Cancer Trials Group
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

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
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)
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%
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
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