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

NCT06963346 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-09

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Romidepsin

Administered as intravesical treatment.

DRUG

Durvalumab

Administered as intravenous treatment.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Joshua A Linscott, MD, PhD · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-24
Primary Completion
2028-04-30
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06963346 on ClinicalTrials.gov