|
Abstract:
|
In a landmark trial of pembrolizumab (KEYNOTE-001), which was initially designed as a Phase I study with < 40 patients, the sample size was adaptively expanded to >1000 patients in the end. The trial has led to multiple regulatory filing and approvals in melanoma and non-small cell lung cancer for patients with an unmet medical need. It has also addressed important questions for the program on predictive biomarker and dose selection. In this presentation, we will discuss strategic, statistical and operational considerations in the planning and execution of this trial.
|
