Immune checkpoint inhibitors and Carbon iON radiotherapy In solid Cancers with stable disease (ICONIC)
Stefano Cavalieri, Viviana Vitolo, Amelia Barcellini, Sara Ronchi, Angelica Facoetti, Chiara Campo, Catherine Klersy, Silvia Molinelli, Francesco Agustoni, Virginia Valeria Ferretti, Annalisa De Silvestri, Marco Platania, Michele Del Vecchio, Marco Durante, Alexander Helm, Claudia Fournier, Filippo de Braud, Paolo Pedrazzoli, Ester Orlandi, Lisa Licitra
Abstract
ICONIC is a multicenter, open-label, nonrandomized phase II clinical trial aiming to assess the feasibility and clinical activity of the addition of carbon ion radiotherapy to immune checkpoint inhibitors in cancer patients who have obtained disease stability with pembrolizumab administered as per standard-of-care. The primary end point is objective response rate, and the secondary end points are safety, survival and disease control rate. Translational research is an exploratory aim. The planned sample size is 27 patients. The study combination will be considered worth investigating if at least four objective responses are observed. If the null hypothesis is rejected, ICONIC will be the first proof of concept of the feasibility and clinical activity of the addition of carbon ion radiotherapy to immune checkpoint inhibitors in oncology.