Canadian Cancer Trials Group - Tumour Bank
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I228 Details
Status: Closed 
Activation Date: 2016OCT19
Closing Date: 2020JAN21
Phase: II 

Description: A Phase II Study of Durvalumab and Tremelimumab in Patients with Advanced Rare Tumours  

Eligibility: Clinically and/or radiologically documented disease, with at least one measurable lesion as defined by RECIST 1.1; >=16 years of age; ECOG 0 or 1; no limit on number of prior chemo; No therapy with PD-1/PD-L1 or CTLA-4 inhibitors. No prior autoimmune or inflammatory disorders ie inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome , etc., within the past 3 years prior to the start of treatment. No history of primary immunodeficiency, allogenic organ transplant that requires therapeutic use of IO agents within 28 days. No attenuated vaccination administered within 30 days. No untreated symptomatic brain mets or in whom radiation or surgery is indicated. NO pts with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. 

Objective: To evaluate the objective response rate of the combination of durvalumab and tremelimumab given by IV every 4 weeks in patients with rare tumours. To explore the correlation between anti-tumour activity and PD-L1 expression, presence of tumour infiltrating lymphocytes (TILs) and T cell subsets within the tumour. To explore the correlation between anti-tumour activity and genomic alterations in tumour. To assess the consistency of histopathological diagnosis of rare tumours through central review of pathology specimens. To explore the correlation between anti-tumour activity and toxicity with blood based biomarkers. To evaluate the tolerability and safety of durvalumab and tremelimumab combination. To evaluate the effect of durvalumab and tremelimumab combination including time to progression, progression free survival and response duration.  

Participation: Limited to invited centres 

Lay Description: This trial looks at how well patients respond to immunotherapy alone. This trial accepts patients with 7 different types of rare cancers: Salivary carcinoma (excluding adenoid cystic carcinoma histology) ; Carcinoma of unknown primary with tumour infiltrating lymphocytes (TILs) and/or expressing PD-L1 3; Mucosal melanoma; Osteosarcoma; Undifferentiated pleomorphic sarcoma; Clear cell carcinoma of the ovary and Squamous cell carcinoma of the anal canal (SCCA), that are metastatic. 

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Inventory
Hide Tissue Samples
Disease Site Trial Code Patients Accrued Patients - Blocks Patients - Slides Patients - Blocks and/or Slides
IND I228 175 63 172 172
Hide TMA Samples
(Core size is 0.6 mm)
Disease Site Trial Code Patients Accrued TMA Blocks Patients on TMA Blocks
IND I228 175 1 14
Hide Fluid Samples
Disease Site Trial Code Patients Accrued Patients - Whole Blood Patients - Cellular Component of Blood Patients - DNA extracted from Blood Patients - RNA extracted from Blood Patients - Plasma Patients - Serum Patients - Urine Patients - Buccal
IND I228 175 0 0 0 0 135 0 0 0