NCI mpact: National Cancer Institute molecular profiling-based assignment of cancer therapy.

TPS2642 Background: There is growing interest in matching targeted agents to genetic aberrations found in tumors of patients in early phase trials. MPACT is a randomized trial designed to assess whether response rate (CR+PR) and progression-free survival (PFS) are improved following treatment with agents chosen based on the presence of specific mutations in patient tumors compared to treatment regimens assigned from the complementary set not prospectively identified to target one of their mutations. Methods: Eligible adult patients have refractory solid tumors that had progressed following at least one line of standard therapy (std) and/or for which no std has been shown to improve survival. Patients are required to undergo tumor biopsy, which will be sequenced in a CLIA-certified lab for the presence of specific actionable mutations of interest (aMOIs) in 20 genes belonging to 3 pathways: DNA repair, PI3K, and RAS/RAF (total of 391 aMOIs). Patients in whom an aMOI is detected will be randomized 2:1 into ...