Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents

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).

Trial Details

NCT ID
NCT06963346
Phase
PHASE1
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • Romidepsin
  • Durvalumab
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

  • Patients must have histologically confirmed MIBC (T2-T4a, N0, M0 per American Joint Commission on Cancer \[AJCC\]) pure or mixed histology urotheli…
  • Patients must be ineligible for cisplatin-based chemotherapy due to any of the following: Creatinine clearance (CrCl) \< 60 mL/min by the Cockcroft…
  • Patients must be medically fit for TURBT and radical cystectomy (RC
  • Age ≥ 18 years

For full eligibility, visit ClinicalTrials.gov.

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