Clinical Trials Corner: Optimizing Papillary Renal Cell Carcinoma Care

Abstract

The Clinical Trials Corner of Kidney Cancer highlights planned or ongoing high-impact studies in renal cell 8 carcinoma (RCC). In this issue, we highlight the PAPMET-2 study, an important Phase II study evaluating the 9 treatment of patients with advanced papillary renal cell carcinoma (pRCC). 10 In future, if you feel that you would like to draw attention to a specific trial, A Phase II Randomized Trial of Cabozantinib (NSC#761968) With or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma Study Design: This study enrolls patients with metastatic histologically confirmed pRCC (either Type 1 or Type 34 2) with radiographically measurable disease who are ICI- and cabozantinib-na¨ıve and who have been treated 35 with one or fewer targeted therapies for pRCC. Following enrollment, patients are randomized to receive either 36 60 mg of cabozantinib orally or 60 mg of cabozantinib orally plus atezolizumab 1200 mg intravenously every 3 37 weeks, until the time of disease progression or unacceptable toxicity. 38 Endpoints: The primary endpoint of this trial is progression-free survival (PFS). Key secondary outcomes include 39 overall survival (OS), objective response rate (ORR), and quantitative & qualitative adverse events observed in 40 each treatment arm. 41 as trials combining nivolumab with cabozantinib have treated patients with 40 mg of cabozantinib daily; in this study, the dose will be 60 mg in both arms. Thus, tolerance of this dose level in combination with ICI will be an important observation. The strength of this study is its uniformity in enrolling patients with pRCC, which is important as retrospective studies have reflected heterogeneity in outcomes based on histologic subtypes undoubtedly in part due to differences in responses to currently available therapies.