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Chapter 15  Precision Medicine in Oncology

CANCERTHERAPEUTICS

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Figure 15.3  Clinical trial designs for precision oncology. Basket trials are histology-agnostic studies that typically focus on a variety of tumors that carry a specific genetic mutation using a single agent targeting that mutation. Umbrella trials use multiple drugs that target multiple mutations in a range of tumor types in the context of a single study; they may be random- ized or nonrandomized. Exceptional responders are N-of-1 clinical experiences in which any patient with a tumor type that is unlikely to undergo an objectively defined response demonstrates robust clinical benefit from therapy; characterization of the tumors from such patients can define unique molecular signatures that can be tested for their predictive power in sub- sequent clinical trials for defined patient populations. (Reproduced from Kummar S, Williams PM, Lih CJ, et al. Application of molecular profiling in clinical trials for advanced metastatic cancers. J Natl Cancer Inst 2015;107[4]:djv003.)