The signature program, a series of tissue-agnostic, mutation-specific signal finding trials.

TPS2646^ Background: Here we are introducing a novel signal-finding clinical trial protocol series, termed the Novartis “Signature” program. These are tissue-agnostic, mutation specific protocols that do not include pre-identified clinical trial sites. In part these are responsive to the increased frequency of molecular profiling in the oncology community, and the incidence of patients whose tumors are identified with actionable mutations yet without access to drugs targeting those alterations. As these patients are identified via routine physician-directed profiling, we bring the ‘Protocol to the Patient’, utilizing a rapid study start-up process, such that a de novo site can have one of these trials opened within weeks of the originating patient being identified. Methods: The core of this rapid start-up process includes mandating the use of a non-negotiable standard contract, budget and informed consent, and the use of central IRB. We allow any research experienced site in the US accepting our study mod...