4SC announced the initiation of a second clinical collaboration with the Netherlands Cancer Institute (NKI) on a phase Ib trial in Stage II-III Resectable Urothelial Cancer to explore biomarker-driven pre-operative administration of Domatinostat, Nivolumab and Ipilimumab - TURANDOT. Neoadjuvant immunotherapy is currently one of the most promising areas of clinical development in solid tumor oncology with potential to improve treatment options for patients. The ultimate goal for neoadjuvant therapy is to prevent relapses after definitive surgery and - depending on the indication - consecutive adjuvant therapy, to promote durable disease-free survival. Domatinostat´s immune-modulating capabilities have been demonstrated both preclinically and clinically and led to the interest of the principle investigator, Dr. Michiel van der Heijden (NKI), who is one of the pioneers of neoadjuvant treatment approaches in urothelial carcinoma, to propose and conduct the neoadjuvant TURANDOT study supported by 4SC. The Investigator-sponsored TURANDOT study investigates the neoadjuvant combination of domatinostat, ipilimumab and nivolumab in stage II-III resectable urothelial carcinoma patients. The primary objective of the phase Ib is to demonstrate feasibility and safety of the respective combination(s) in up to 40 patients. Secondary, pathological response and relapse-free survival will be investigated for clinical activity purposes and both will determine any consecutive clinical development activities in this indication and setting. Importantly, in urothelial carcinoma, the predictive value of analyzing non-vital tumor cells taken at time of surgery has been demonstrated and the surrogate endpoint of complete pathological response is already widely accepted.