Researchers Investigate Novel Combinations in Ongoing Trials for RCC

Toni Choueiri, MD, director of the Lank Center for Genitourinary Oncology and director of the Kidney Cancer Center at Dana-Farber Cancer Institute, discusses nivolumab (Opdivo), ipilimumab (Yervoy), and cabozantinib (Cabometyx) combinations in ongoing phase 3 trials as treatment for patients with advanced renal cell carcinoma (RCC).

The ongoing phase 3 COSMIC-313 trial (NCT03937219) is accruing patient with RCC and is examining nivolumab plus ipilimumab as a modern control without sunitinib, compared with a triplet combination of nivolumab, ipilimumab, and cabozantinib, according to Choueiri. This looks at 2 of the 3 drugs which were investigated in the CheckMate 9ER trial (NCT03141177). For CheckMate-9ER, patients with intermediate risk are evaluated for the efficacy of the triplet versus the doublet regimen of nivolumab and cabozantinib.

Another trial currently accruing patients to investigate these drugs is the PDIGREE study (NCT03793166). This study is investigating the combination of the 3 drugs given in a different sequence. Choueiri says it's an academic Alliance-led study that is being conducted in the United States. Patients are given nivolumab plus ipilimumab first, and if they achieve a complete response, they could stop treatment after a year. A patient could be switched to cabozantinib if they have disease progression. The 70% of patients who do not have progressive disease and do not have a complete response will be randomized to nivolumab maintenance, which is what we do normally with nivolumab and ipilimumab or nivolumab and cabozantinib.