Status: Closed
Activation Date: 2016AUG10
Closing Date: 2017JUN29
Phase: II
Description: A Phase II Randomized Study of Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care Alone in Patients with Advanced Colorectal Adenocarcinoma Refractory to Standard Therapies
Eligibility: MAIN INCLUSION CRITERIA: Metastatic pre-treated colorectal cancer; Archival tissue available for correlative analysis; ECOG PS 0,1; Sufficient prior treatment with standard chemotherapy based regimens containing a fluoropyrimidine, irinotecan and oxaliplatin; Measurable or evaluable disease as per RECIST 1.1; MAIN EXCLUSION CRITERIA: Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab, or an anti-CTLA4, including tremelimumab; Medical contraindications to durvalumab (e.g. autoimmune disease); Prior immunotherapy or vaccines; Prior history of immunodeficiency; Prior use of immunosuppressive agents within 28 days, with the exception of corticosteroids (intranasal and inhaled) or systemic corticosteriods at physiological doses.
Objective: PRIMARY: Overall Survival SECONDARY: Progression Free Survival; assess toxicity and safety; Objective Response Rate TERTIARY: QoL; effect of tumour PD-L1 expression on efficacy; explore association between putative biomarkers (in archival tumour, blood, serum and plasma) and potential for clinical benefit
Participation: Open to member centres
Lay Description: The purpose of the study is to compare the effects on colon or rectal cancer of 2 new drugs, durvalumab and tremelimumab, and best supportive care (BSC) compared to BSC alone.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GASTRO-INTESTINAL | CO26 | 180 | 173 | 117 | 178 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GASTRO-INTESTINAL | CO26 | 180 | 1 | 33 |
| 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 |
| GASTRO-INTESTINAL | CO26 | 180 | 169 | 0 | 0 | 0 | 169 | 168 | 0 | 0 |