You have accessJournal of UrologyCME1 Apr 2023PD24-06 ASSESSMENT OF SURGICAL COMPLICATIONS IN PATIENTS WITH METASTATIC CLEAR CELL RENAL CELL CARCINOMA (MCCRCC) RECEIVING PERIOPERATIVE CABOZANTINIB AND NIVOLUMAB ON CYTO-KIK CLINICAL TRIAL Karie Runcie, Moshe Ornstein, Biren Saraiya, Venkatesh Krishnamurthi, Byron Lee, Christopher Anderson, Guarionex DeCastro, James McKiernan, Tina Mayer, Matthew Dallos, Mark Stein, and Eric Singer Karie RuncieKarie Runcie More articles by this author , Moshe OrnsteinMoshe Ornstein More articles by this author , Biren SaraiyaBiren Saraiya More articles by this author , Venkatesh KrishnamurthiVenkatesh Krishnamurthi More articles by this author , Byron LeeByron Lee More articles by this author , Christopher AndersonChristopher Anderson More articles by this author , Guarionex DeCastroGuarionex DeCastro More articles by this author , James McKiernanJames McKiernan More articles by this author , Tina MayerTina Mayer More articles by this author , Matthew DallosMatthew Dallos More articles by this author , Mark SteinMark Stein More articles by this author , and Eric SingerEric Singer More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003302.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The perioperative safety of cabozantinib and nivolumab in mccRCC, and the optimal timing to hold cabozantinib prior to surgery, are unknown. METHODS: In this phase 2 trial, patients with mccRCC are given cabozantinib (40 mg daily) and nivolumab (480 mg q4 weeks) for 12 weeks prior to cytoreductive nephrectomy. Post-operatively, patients resume treatment with cabozantinib and nivolumab until disease progression. A 3+3 design was used to evaluate the safety of the interval (21 or 14 days) between the discontinuation of cabozantinib and nephrectomy. Evaluable patients completed at least 10 of 14 cabozantinib doses prior to the pre-specified period of stopping pre-operative cabozantinib. Surgical complications assessed using the Clavien-Dindo classification system is a secondary endpoint of this study. RESULTS: 16 patients have been enrolled and 14 completed nephrectomy to date. 12 (75%) of patients are male, 4 (25%) female, ages 44-77 years old with median age at diagnosis 58.5 years old. BMIs ranged from 17.8 kg/m2 to 39.3 kg/m2 with median BMI of 28.7 kg/m2. 63% of patients were classified by IMDC as intermediate-risk and 37% as poor-risk disease. Dose reductions of cabozantinib occurred in 14% of patients who completed nephrectomy and cabozantinib held in 42% of nephrectomy patients during the course of treatment. Three evaluable patients completed nephrectomy within the 21-day interval and 5 within the 14-day interval after discontinuation of cabozantinib. There were no treatment-related surgical complications in patients who completed nephrectomy and there were no delays in resuming combination systemic therapy after surgery. CONCLUSIONS: Combination cabozantinib and nivolumab can be safely administered up to 14 days prior to cytoreductive nephrectomy. Clinical trial information: NCT04322955. Source of Funding: Exelixis, Inc., Bristol Myers Squibb © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e724 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Karie Runcie More articles by this author Moshe Ornstein More articles by this author Biren Saraiya More articles by this author Venkatesh Krishnamurthi More articles by this author Byron Lee More articles by this author Christopher Anderson More articles by this author Guarionex DeCastro More articles by this author James McKiernan More articles by this author Tina Mayer More articles by this author Matthew Dallos More articles by this author Mark Stein More articles by this author Eric Singer More articles by this author Expand All Advertisement PDF downloadLoading ...