
The FDA issued final guidances on performance status, washout periods, and laboratory values aimed at expanding oncology trial participation.
Hans Hammers, MD, PhD, associate professor, Internal Medicine, UT Southwestern Medical Center, discusses the CheckMate-214 study for patients with renal cell carcinoma (RCC).
Hans Hammers, MD, PhD, associate professor, Internal Medicine, UT Southwestern Medical Center, discusses the CheckMate-214 study for patients with renal cell carcinoma (RCC).
CheckMate-214 is a large phase III trial that randomized 1000 patients to nivolumab (Opdivo) plus ipilimumab (Yervoy) or sunitinib (Sutent). The primary analysis was focused on the intermediate- and poor-risk patients, explains Hammers.
A median progression-free survival (PFS) was a challenge to achieve, but according to Hammers, the combination will become the new standard of care.

