High magnification micrograph of a clear cell renal cell carcinoma. Credit: Nephron.

Exelixis is initiating a Phase III pivotal trial to evaluate cabozantinib (CABOMETYX) for the treatment of patients with previously untreated advanced renal cell carcinoma (RCC).

As part of the trial, cabozantinib will be evaluated in combination with nivolumab (Opdivo) and ipilimumab (Yervoy) versus nivolumab and ipilimumab provided by Bristol-Myers Squibb.

The primary endpoint of the COSMIC-313 trial is progression-free survival, and the secondary endpoints are overall survival and objective response rate.

Exelixis Product Development and Medical Affairs president and chief medical officer Gisela Schwab said: “Clinical observations suggest cabozantinib promotes an immune-permissive environment, which could present an opportunity for additive or synergistic effects with immune checkpoint inhibitors.

“The mechanisms of action of single-agent cabozantinib and the combination of nivolumab and ipilimumab are complementary.”

“The mechanisms of action of single-agent cabozantinib and the combination of nivolumab and ipilimumab are complementary, and each has demonstrated efficacy in advanced renal cell carcinoma.

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“The further combination of these agents as a triplet regimen may offer promise to previously untreated patients with intermediate or poor-risk disease, who are known to have poor treatment outcomes.”

For the multi-centre, randomised, double-blinded, controlled Phase III pivotal trial COSMIC-313 about 676 patients are expected to be enrolled at 150 sites across the globe.

Patients will be randomised 1:1 to cabozantinib’s experimental arm in combination with nivolumab and ipilimumab and to the control arm of nivolumab and ipilimumab in combination with matched placebo.

Design of this trial was informed by results from the ongoing Phase Ib study of cabozantinib plus nivolumab with or without ipilimumab in patients with previously treated advanced genitourinary cancers, including RCC.

The US National Cancer Institute is conducting the Phase Ib trial.

This February, Exelixis announced the commencement of a Phase I clinical trial to evaluate XL092 for the treatment of various cancer types.