The target number of patients with advanced renal cell carcinoma has been enrolled in the phase 3 CONTACT-3 trial, which aims to determine the efficacy and safety of cabozantinib combined with atezolizumab.
The phase 3 CONTACT-3 trial which is evaluating the use of cabozantinib (Cabometyx) in combination with atezolizumab (Tecentriq) in patients with locally advanced or metastatic clear cell or non-clear cell renal cell carcinoma (RCC) who progressed during or following treatment with an immune checkpoint inhibitor (ICI) as the immediately preceding line of therapy, has completed enrollment.1
“With multiple new treatment options approved for kidney cancer over the last decade, there is a need to better understand how therapies can be used sequentially to help address critical unmet needs for this patient population,” said Michael M. Morrissey, PhD, president, and chief executive officer, Exelixis, in a press release.
The global, multicenter, open-label, randomized phase 3 CONTACT-03 study has enrolled a total of 523 patients with locally advanced or metastatic clear cell or non-clear cell RCC. The patients will be randomized 1:1 to receive either 60 mg of oral cabozantinib once daily with 1200 mg of intravenous atezolizumab every 3 weeks or atezolizumab alone. The design of the study was informed by information from the ongoing COSMIC-021 clinical trial. The overarching goal of the study is to determine the efficacy and safety of the combination compared with atezolizumab alone.1,2
The coprimary end points being explored in CONTACT-03 include progression-free survival (PFS) assessed by Independent Review Facility (IRF) and overall survival. The secondary end points include PFS assessed by investigators, objective response rate, duration of response, duration of complete response, the percentage of patients with adverse events, atezolizumab Concentrations, cabozantinib concentrations, the prevalence of anti-drug antibodies (ADAs) to atezolizumab, and the incidence of ADAs to atezolizumab during the study.2
RCC in the study subjects must be histologically or cytologically confirmed. Patients with sarcomatoid features are eligible to enroll. Other requirements for inclusion in the study include measurable disease per RECIST v1.1, evaluable IMDC risk score, tumor tissue available for biopsy, a Karnofsky Performance Score of 70 or higher, and adequate hematologic and end-organ function. HIV and Hepatitis B and C tests must be negative at the time of enrollment.
Patients with advanced RCC may be excluded from the study based on prior treatment, comorbidities, or medical history. In terms of previous therapy, anti-cancer treatment within 14 days of the study’s initiation, prior cabozantinib, receipt of more than one ICI, and radiotherapy within 14 days of cycle 1 are all prohibited.
“Now that CONTACT-03 has completed enrollment, we look forward to sharing initial results when the data mature, which will offer insight into the potential of cabozantinib in combination with atezolizumab for patients who have progressed following treatment with an immune checkpoint inhibitor,” said Morrissey, in the press release.1
1. Exelixis announces enrollment completion in Phase 3 CONTACT-03 pivotal trial of cabozantinib in combination with an immune checkpoint inhibitor in previously treated metastatic renal cell carcinoma. News release. Exelixis, Inc. January 5, 2022. Accessed January 10, 2022. https://bit.ly/3qcycvG
2. A study of atezolizumab in combination with cabozantinib compared to cabozantinib alone in participants with advanced renal cell carcinoma after immune checkpoint inhibitor treatment (CONTACT-03). ClinicalTrials.gov. Accessed January 10, 2022. https://bit.ly/3JYksMY