An open-label, phase 3 trial will evaluate cabozantinib plus atezolizumab among patients with advanced renal cell carcinoma (RCC) whose disease progressed with immune checkpoint inhibitor (ICI) treatment, according to an abstract presented at the 19th Annual Meeting of the International Kidney Cancer Symposium (IKCS 2020).

Results of a phase 1b trial suggested that cabozantinib plus atezolizumab had favorable efficacy and safety in RCC. The purpose of the phase 3 trial is to further evaluate the efficacy and safety of this combination as a second or third-line treatment for RCC.

The international, open-label, phase 3 CONTACT-03 trial is plans to enroll 500 patients with advanced clear cell or non–clear cell RCC who developed radiographic progression of disease while receiving an ICI or after treatment with an ICI.

Patients who previously received cabozantinib or adjuvant ICI were excluded. Patients will be randomly assigned in a 1:1 ratio to receive cabozantinib plus atezolizumab or cabozantinib monotherapy until loss of clinical benefit or untolerable toxicity.


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The coprimary endpoints will be progression-free survival (PFS) and overall survival (OS) as assessed by an independent review facility. Secondary endpoints include investigator-assessed PFS, objective response rate, duration of response, quality of life measures, biomarkers, and safety. Efficacy will be evaluated as per RECIST v1.1.

Reference

Pal SK, Albiges L, Suárez C, et al. CONTACT-03: randomized, open-label phase III study of atezolizumab plus cabozantinib vs cabozantinib monotherapy following progression on/after immune checkpoint inhibitor (ICI) treatment in patients with advanced/metastatic renal cell carcinoma (RCC). Presented at: 19th Annual Meeting of the International Kidney Cancer Symposium (IKCS 2020); November 6-7, 2020.  Abstract TIP138.

This article originally appeared on Cancer Therapy Advisor