TY - JOUR
T1 - The JAVELIN Bladder Medley trial
T2 - avelumab-based combinations as first-line maintenance in advanced urothelial carcinoma
AU - Hoffman-Censits, Jean
AU - Grivas, Petros
AU - Powles, Thomas
AU - Hawley, Jessica
AU - Tyroller, Karin
AU - Seeberger, Sonja
AU - Guenther, Silke
AU - Jacob, Natalia
AU - Mehr, Keyvan Tadjalli
AU - Hahn, Noah M.
N1 - Publisher Copyright:
© 2023 The Authors.
PY - 2024/2/1
Y1 - 2024/2/1
N2 - 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.
AB - 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.
KW - JAVELIN Bladder Medley
KW - M6223
KW - NKTR-255
KW - advanced urothelial carcinoma
KW - avelumab
KW - maintenance
KW - phase II trial
KW - sacituzumab govitecan
UR - http://www.scopus.com/inward/record.url?scp=85180701292&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85180701292&partnerID=8YFLogxK
U2 - 10.2217/fon-2023-0492
DO - 10.2217/fon-2023-0492
M3 - Article
C2 - 37671748
AN - SCOPUS:85180701292
SN - 1479-6694
VL - 20
SP - 179
EP - 190
JO - Future Oncology
JF - Future Oncology
IS - 4
ER -