MedTrace Logo

Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma

NCT05154994 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-07

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of belinostat when given together with durvalumab in treating patients with urothelial cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Belinostat is a potential anti-cancer drug, known as a histone deacetylase (HDAC) inhibitor, which means that belinostat stops the activity of HDAC enzymes (an enzyme is a protein that in small amounts can speed up a biological reaction). HDAC enzymes play an important role in cell growth and cell death. Giving durvalumab and belinostat may improve the body's ability to fight cancer.

Conditions

  • Infiltrating Urothelial Carcinoma, Sarcomatoid Variant
  • Locally Advanced Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Unresectable Urothelial Carcinoma

Interventions

DRUG

Belinostat

Given IV

BIOLOGICAL

Durvalumab

Given IV

Sponsors & Collaborators

Principal Investigators

  • Sumati V Gupta · Huntsman Cancer Institute/ University of Utah

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2026-08-31
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT05154994 on ClinicalTrials.gov