Integration of healthy volunteers in early phase clinical trials with immuno-oncological compounds.

Radanovic I, Klarenbeek N, Rissmann R, Groeneveld GJ, van Brummelen EMJ, Moerland M, Bosch JJ

Traditionally, early phase clinical trials in oncology have been performed in patients based on safety risk-benefit assessment. Therapeutic transition to immuno-oncology may open new opportunities for studies in healthy volunteers, which are conducted faster and are less susceptible to confounders. Aim of this study was to investigate to what extent this approach is utilized and whether pharmacodynamic endpoints are evaluated in these early phase trials. We conducted a comprehensive review of clinical trials with healthy volunteers using immunotherapies potentially relevant for oncology.