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

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Updated on 21 October 2022

See if I qualify

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 Identifier	NCT03847649
Sponsor	Canadian Cancer Trials Group
Last Modified on	21 October 2022

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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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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