Trial of Triplet Regimen With Cabozantinib Plus Immunotherapy Is Planned in RCC

Rachel Narozniak
Published: Sunday, Jul 07, 2019
Gisela Schwab, MD

Gisela Schwab, MD
Investigators see potential in adding targeted therapy to dual immunotherapy for intermediate- and poor-risk patients with renal cell carcinoma (RCC).1 In the phase III COSMIC-313 trial (NCT03937219), investigators aim to evaluate cabozantinib (Cabometyx), nivolumab (Opdivo), and ipilimumab (Yervoy) in patients with untreated advanced RCC.

The double-blind, controlled study will recruit up to 676 patients and randomize them 1:1 to receive cabozantinib in combination with nivolumab and ipilimumab or nivolumab and ipilimumab plus matched placebo (Figure).

“COSMIC-313 is notable for being the first phase III pivotal trial to compare a [tyrosine kinase inhibitor]/checkpoint inhibitor combination with the combination of nivolumab and ipilimumab already approved in the first-line RCC setting,” Gisela Schwab, MD, president of product development and medical affairs and chief medical officer for Exelixis, said in an interview with OncologyLive®.

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