Cabozantinib plus nivolumab-ipilimumab will be evaluated in a double-blind, placebo-controlled phase 3 trial of patients with previously untreated clear cell renal cell carcinoma (ccRCC), according to a poster presented at the 19th Annual Meeting of the International Kidney Cancer Symposium (IKCS 2020).

Both cabozantinib and nivolumab-ipilimumab are approved separately for the first-line treatment of patients with advanced RCC. Preclinical data suggest that cabozantinib may promote a tumor microenvironment conducive to immune checkpoint inhibition.

This global, phase 3 trial is planning to enroll 676 patients with previously untreated ccRCC of intermediate to poor risk, who will be randomly assigned in a 1:1 fashion to receive cabozantinib plus 4 cycles of nivolumab-ipilimumab, or placebo plus 4 cycles nivolumab-ipilimumab. Patients will receive cabozantinib or placebo maintenance therapy, respectively.

Tumor assessment will occur every 8 weeks and treatment will continue until loss of clinical benefit or intolerable toxicity.


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The primary endpoint will be progression-free survival assessed by a blinded independent radiology committee according to RECIST v1.1. The secondary endpoints include overall survival, objective response rate, duration of response, and safety. Blood samples and tumor tissue will be collected for biomarker assessments, including PD-L1, MET, T-cell infiltration, tumor mutational burden, circulating immune cells, and plasma biomarkers.

The study is currently open to enrollment in North America, South America, Europe, and the Asia-Pacific region.

Disclosure: The research described here was supported by Exelixis, Inc. For a full list of disclosures, please refer to the original abstract.

Reference

Choueiri TK, Albiges L, Powles T, et al. A phase 3 study (COSMIC-313) of cabozantinib in combination with nivolumab and ipilimumab in patients with previously untreated advanced renal cell carcinoma of intermediate or poor risk. Presented at: 19th Annual Meeting of the International Kidney Cancer Symposium (IKCS 2020); November 6-7, 2020. Abstract TIP140.

This article originally appeared on Cancer Therapy Advisor