4SC AG announced that the Netherlands Cancer Institute (NKI) in Amsterdam has enrolled the first patient in TURANDOT - a multicenter, investigator-sponsored phase 1b study conducted by Prof. Michiel van der Heijden at the NKI, Amsterdam, the Netherlands, testing the combination of domatinostat and checkpoint inhibition in stage II-III resectable urothelial carcinoma in the neoadjuvant setting. The TURANDOT study investigates safety, feasibility and proof-of-principle of the addition of domatinostat to pre- operative immune checkpoint inhibition (CPI) with nivolumab and ipilimumab. Urothelial cancer patients will be included that are diagnosed with resectable stage II-III disease and PD-L1 status will determine the treatment cohort. Within each cohort, patients will be randomized to receive CPI + domatinostat or CPI alone. The primary endpoint is feasibility of neo-adjuvant domatinostat + nivolumab +/- ipilimumab defined by percentage of patients who are able to have surgical resection within 12 weeks. Main secondary endpoints are efficacy endpoints such as pathological complete response (pCR), relapse-free survival (RFS) and overall survival (OS), and safety. In addition, the study comprises a comprehensive translational research program.Jason Loveridge, Ph.D., CEO of 4SC: "Such a very rapid start to TURANDOT signals a high level of interest in both the neoadjuvant setting as well as the combination of domatinostat and checkpoint blockade in this population and look forward to further patients enrolling in 2021.