The New NCI Precision Medicine Trials.
Lyndsay N HarrisCharles David BlankeHarry P ErbaJames M FordRobert J GrayMichael L LeBlancSiwen Hu-LieskovanMark R LitzowSelina M LugerFunda Meric-BernstamPeter J O'DwyerMegan K D OthusKaterina PolitiLois E ShepherdCarmen J AllegraHelen X ChenSusan Percy IvyLarissa A KordeRichard F LittleLisa Meier McShaneJeffrey A MoscowDavid R PattonMagdalena ThurinLaura M YeeJames H DoroshowPublished in: Clinical cancer research : an official journal of the American Association for Cancer Research (2023)
Basket, umbrella, and platform trial designs (master protocols) have emerged over the last decade to study precision medicine approaches in oncology. First generation trials like NCI-MATCH have proven the principle that studying targeted therapies on a large scale is feasible both from the laboratory and clinical perspectives. However, single agent targeted therapies have shown limited ability to control metastatic disease, despite careful matching of drug to target. As such, newer approaches employing combinations of targeted therapy, or targeted therapy with standard therapies, need to be considered. The NCI has recently embarked on three 2nd generation precision medicine trials to address this need: ComboMATCH, iMATCH, and myeloMATCH. The design of these trials and necessary infrastructure are discussed in the following perspective.