H. Lee Moffitt Cancer Center and Research Institute
In this study, we aim to evaluate the safety and efficacy of neoadjuvant combination using intravesical romidepsin and durvalumab in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC).
Inclusion Criteria: * Patients must have histologically confirmed MIBC (T2-T4a, N0, M0 per American Joint Commission on Cancer \[AJCC\]) pure or mixed histology urothelial carcinoma. * Patients must be ineligible for cisplatin-based chemotherapy due to any of the following: Creatinine clearance (CrCl) \< 60 mL/min by the Cockcroft-Gault formula; Hearing impaired ≥ Grade 2 by CTCAE criteria; Neuropathy ≥ Grade 2 by CTCAE criteria; Heart failure NYHA ≥ III; ECOG ≥ 2. * Patients must be medically fit for TURBT and radical cystectomy (RC * Age ≥ 18 years * Body weight \>30 kg * Ability to underst…
Administered as intravesical treatment.
Administered as intravenous treatment.
Arctuva estimate
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