Overview of design
multiple cancer
RECRUITMENT, MULTIPLE CANCER
REFINE is a phase II, multi-arm multi-stage (MAMS) basket trial investigating extended interval administration of ICI across multiple cancer types. It is a preliminary step towards a DURATIONS trial [Interim results will be analysed approximately 6 months from completion of stage I recruitment when the majority of patients will have had a least 9 months on trial (i.e. 1 year after starting ICI). These results will inform stage II which will investigate up to 5 different treatment intervals in subsequently recruited patients. An amendment will be submitted to the MHRA for approval prior to the commencement of the second stage.Completion of the first two stages of REFINE will demonstrate the feasibility of recruiting to a phase III trial testing extended dosing interval of administration of different ICI in responding patients across multiple indications.