The JAVELIN Bladder Medley Trial: Avelumab-Based Combinations as First-Line Maintenance in Advanced Urothelial Carcinoma
Jean Hoffman‐Censits, Petros Grivas, Thomas Powles, Jessica E. Hawley, Karin Tyroller, Sonja Seeberger, Silke Guenther, Natalia Jacob, Keyvan Tadjalli Mehr, Noah M. Hahn
Abstract
Results from JAVELIN Bladder 100 established avelumab (anti-PD-L1) first-line maintenance as the standard-of-care treatment for patients with advanced urothelial carcinoma (UC) that has not progressed with first-line platinum-based chemotherapy. We describe the design of JAVELIN Bladder Medley (NCT05327530), an ongoing phase II, multicenter, randomized, open-label, parallel-arm, umbrella trial. Overall, 252 patients with advanced UC who are progression-free following first-line platinum-based chemotherapy will be randomized 1:2:2:2 to receive maintenance therapy with avelumab alone (control group) or combined with sacituzumab govitecan (anti-Trop-2/topoisomerase inhibitor conjugate), M6223 (anti-TIGIT) or NKTR-255 (recombinant human IL-15). Primary end points are progression-free survival per investigator and safety/tolerability of the combination regimens. Secondary end points include overall survival, objective response and duration of response per investigator, and pharmacokinetics.