ENERGIZE: A Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer

Guru Sonpavde, Andrea Necchi, Shilpa Gupta, Gary D. Steinberg, Juergen E. Gschwend, Michiel Simon van der Heijden, Nathalie Garzon, Mohammed Ibrahim, Bradley Raybold, Danny Liaw, Mark Rutstein, Matt D. Galsky

Research output: Contribution to journalReview article*Academicpeer-review

Abstract

Immune checkpoint inhibitors have revolutionized the treatment of patients with metastatic urothelial carcinoma. In cisplatin-eligible muscle-invasive bladder cancer (MIBC), cisplatin-based neoadjuvant chemotherapy (NAC) before radical cystectomy improves overall survival. Tumor PD-L1 expression increases in MIBC after NAC, suggesting potential synergy in combining PD1/PD-L1 inhibitors with NAC. IDO1 is overexpressed in bladder cancer and is associated with poor outcomes. Linrodostat mesylate (BMS-986205)-a selective, potent, oral IDO1 inhibitor-combined with nivolumab has demonstrated safety and preliminary evidence of clinical activity in metastatic urothelial carcinoma. Here, we discuss the rationale and trial design of the ENERGIZE, a Phase III trial investigating the efficacy of NAC in combination with nivolumab with or without linrodostat followed by postsurgery nivolumab or nivolumab with linrodostat in cisplatin-eligible patients with MIBC. Clinical trial registration number: NCT0366132.
Original languageEnglish
Pages (from-to)4359-4368
JournalFuture oncology (London, England)
Volume16
Issue number2
DOIs
Publication statusPublished - 2019

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