NCI's Precision Medicine Clinical Trial, NCI-Molecular Profiling-based Assignment of Cancer Therapy (NCI-MPACT), Opens at Sites across the Country

The NCI-sponsored precision medicine trial, NCI-Molecular Profiling-based Assignment of Cancer Therapy (NCI-MPACT), opened to patient recruitment in March 2013 in NCI's Developmental Therapeutics Clinic (DTC) in Bethesda, MD. The goal of NCI-MPACT is to determine if targeting the actions of specific oncogenic drivers in three main genetic pathways (DNA repair, PI3K, or RAS/RAF/ MEK) found in advanced solid tumors will be beneficial to patients compared to treatment with a complementary set of therapy. NCI-MPACT is a Phase 2 study, where patients are randomized to one of two treatment arms: patients in Arm A receive one of the four regimens where the therapy targets their specific mutation, whereas patients in Arm B will receive one of the four regimen that does not specifically correspond to their mutation.

The targeted therapies are:

• veliparib (PARP inhibitor) with temozolamide (DNA repair pathway)>
• AZD-1775 (Wee1 inhibitor) plus carboplatin (DNA repair pathway)
• everolimus (mTOR inhibitor; PI3K pathway)
• trametinib DMSO (MEK inhibitor; RAS/RAF/MEK pathway)

NCI-MPACT plans to enroll 700 patients for biopsy screening in order to evaluate a minimum of 180 patients on the two treatment arms. Due to its complexity, the original plan was to test the feasibility of NCI-MPACT at DTC before opening the trial in the NCI-sponsored Experimental Therapeutics Clinical Trials Network (ETCTN). In May 2016, NCI-MPACT opened in the ETCTN, which will greatly expand the trial's reach to populations across the country. NCI-MPACT's adjustment to a multi-site clinical trial is expected to increase patient accrual rate and confirm the feasibility of multi-site, real-time molecular profiling to guide cancer treatment.