Design and conduct of early clinical studies of immunotherapy agent combinations: recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies.

摘要: ABSTRACT The Methodology for the Development of Innovative Cancer Therapies task force considered aspects design and conduct early studies combinations immunotherapy agents during their 2018 meeting. defined relevant data to justify combination clinical trials, which includes a robust hypothesis combination, pre-clinical with evidence efficacy an understanding pharmacodynamics effects each agent, ideally single agent activity. Evaluation pharmacodynamic biomarkers is critical in phase should be incorporated into trial objectives go/no-go decisions. also identified need develop assessment tools end points that capture unique patterns tumour responses immunotherapy, including pseudoprogression hyperprogression. At least one additional measurement before baseline CT scan (at 4 weeks example) would help define incidence hyperprogression, although common definition needed. Finally, highlighted substantial redundancy inefficiency space, recommended adoption innovative designs.