Canadian Profiling And Targeted Agent Utilization Trial (Captur/Pm.1): A Phase Ii Basket Precision Medicine Trial.

TPS12127 Background: Genomic profiling of cancers is increasingly used to refine prognostication and aid in treatment decisions by allowing matching of targeted agents to specific genetic variants. Clinical reports to date suggest that 30-80% of advanced solid tumours harbor potentially actionable genomic variants but difficulties in obtaining matched targeted agents in clinical practice limits the application of precision medicine. CAPTUR is a pan-Canadian trial leveraging existing clinical genomic profiling platforms and the research capabilities of the Canadian Cancer Trials Group (CCTG) to evaluate targeted drug-genetic variant matches in patients with advanced cancers. CAPTUR was developed in collaboration, and plans to share data, with ASCO’s TAPUR and the Netherland’s DRUP trials. Methods: CAPTUR/PM.1 (NCT03297606) is a multi-centre, open-label, phase II basket trial, matching Canadian patients who have undergone genomic profiling with genetic variants to appropriate targeted agents. Drug matches are drawn from a list of 17 commercially available anticancer agents. Patients must have incurable metastatic solid tumours, multiple myeloma, or B cell non-Hodgkin lymphoma, must have no standard treatment options known to prolong life and must have an actionable genomic variant known to be a target of, or predict sensitivity to, the commercially available targeted anticancer drug. Patients who possess an actionable tumour genetic variant and meet non-drug specific study requirements are entered into the study. A drug-variant match is assigned based on protocol specified matching criteria or input of the Molecular Tumour Board. Determination of the best treatment is then made by physician and patient based on drug-specific eligibility requirements. Cohorts are defined by tumour type, genomic alteration and matched drug treatment. The primary endpoint is response rate, as determined by disease-appropriate objective criteria. Maximum sample size per cohort is 24 patients based on a Simon 2-stage admissible design. Maximum planned number of cohorts is 30 (maximum sample size for the trial of 720 patients). CAPTUR was activated November 2017 and is open to enrolment. Clinical trial information: NCT03297606.