HERO Trial: Phase I Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents in Localized Bladder Cancer
H. Lee Moffitt Cancer Center and Research Institute
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugRomidepsin
Administered as intravesical treatment.
- DrugDurvalumab
Administered as intravenous treatment.
Location
- Moffitt Cancer CenterTampa, Florida