Dr. Zhang on the Key Objectives of the PDIGREE Trial in Advanced RCC

Tian Zhang, MD, assistant professor of medicine, Duke University School of Medicine, member, Duke Cancer Institute, discusses the ongoing phase 3 PDIGREE trial (NCT03793166), evaluating the combination ipilimumab (Yervoy) plus nivolumab (Opdivo), followed by nivolumab with or without cabozantinib (Cabometyx), in patients with advanced renal cell cancer (RCC).

The PDIGREE study, which is in the process of enrolling patients, is currently one of the only open phase 3 trials the first-line setting in the United States, according to Zhang. Thus far, investigators have observed some benefit with the study treatments, in terms of improving overall survival (OS), Zhang adds.

The primary end point of the study is the 3-year landmark OS, and key secondary end points have been established to help better understand the sequencing of treatment, Zhang says. Patients will also stop treatment at 1 year to determine complete responses, making the trial one of the first prospective discontinuation treatment studies in kidney cancer. The study will help to inform how patients respond to treatment, whether treatment can be stopped, and how best to sequence therapy, Zhang concludes.