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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06963346
Phase
PHASE1
Status
Suspended

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Romidepsin — DRUG
    Administered as intravesical treatment.
  • Durvalumab — DRUG
    Administered as intravenous treatment.

Study Details

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).

Key Dates

Start date
Jun 24, 2025
Status verified
Mar 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1
    Romidepsin Level 1: 0.2 ng/ml on C1D1. Durvalumab: The recommended fixed dose of durvalumab is 1500 mg every 4 weeks and will be given on C1D1 and C2D1.
  • Experimental: Dose Level 2
    Romidepsin Level 2: 0.4 ng/ml on C1D1. Durvalumab: The recommended fixed dose of durvalumab is 1500 mg every 4 weeks and will be given on C1D1 and C2D1.
  • Experimental: Dose Level 3
    Romidepsin Level 3: 2.0 ng/m on C1D1. Durvalumab: The recommended fixed dose of durvalumab is 1500 mg every 4 weeks and will be given on C1D1 and C2D1.

Primary Outcome Measure

Romidepsin Maximum Tolerated Dose (MTD) [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Moffitt Cancer Center· Tampa, FL

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