DSMB evaluation
toxicity, Cancer
SKIN TOXICITY, CANCER
A DSMB was established, consisting of Prof. Dr. D. Schadendorf (University Hospital Essen), Prof. Dr. R. Dummer (University of Zurich), Dr. V. Sondak (Moffitt Cancer Center), and Dr. S. Suciu (European Organization for Research and Treatment of Cancer). The DSMB consultation plan was to evaluate the safety and feasibility of all treatment regimens based on the predefined stopping rules for feasibility after inclusion of 5 and 10 patients in each arm, and to decide on dose (de-)escalation of the triple therapy in arm D. The DSMB advised to continue in arm D with the same domatinostat dose (200 mg QD) after inclusion of 5 patients due to two cases of grade 3 immunotherapy-related toxicity, but advised to increase the dose of domatinostat to 200 mg BID (in arm D-exp) after 10 patients. After inclusion of four patients in arm D-exp, the DSMB agreed that it was reasonable to stop further inclusion of patients due to the dose limiting skin toxicity and lack of improved efficacy.