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NCT05154994 · ClinicalTrials.gov registry record · Phase 1

Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma

A Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by University of Utah.

Active
Registry status
Phase 1
Development phase
9
Enrollment target
1
Study location

NCT05154994: Active Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by University of Utah.

NCT05154994 is a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma that is active but no longer recruiting, run by University of Utah. The registered enrollment target is 9 participants, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05154994, a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, is active but no longer recruiting, sponsored by University of Utah.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
9 participants
Enrollment target
1
Study location

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.

Primary Outcome

Rate of DLTs during the defined DLT period for belinostat dose escalation. The number and proportion of DLTs will be reported for each dose level. An exact 95% confidence interval will be reported for each dose level with more than one patient.

Conditions Studied

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

Interventions

  • BIOLOGICAL Durvalumab
  • DRUG Belinostat

Study Locations (1)

Utah

  • Huntsman Cancer Institute/University of Utah - Salt Lake City

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2022-01-14
Est. Completion 2027-11-30
Phase Phase 1
University of Utah

818 total trials

What the registry record for NCT05154994 still lists

NCT05154994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (93% lower).

The record links to 4 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.

NCT05154994 reports a single indexed study location in Utah.

Frequently Asked Questions

What is clinical trial NCT05154994 about?

NCT05154994 is a clinical study titled "Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma". 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 nod...

What is the current status of trial NCT05154994?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2022-01-14. Estimated completion is 2027-11-30.

What conditions does trial NCT05154994 study?

This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Unresectable Urothelial Carcinoma, Infiltrating Urothelial Carcinoma, Sarcomatoid Variant.

What interventions are being tested in trial NCT05154994?

The interventions under investigation include: Durvalumab (BIOLOGICAL), Belinostat (DRUG).

Who is sponsoring clinical trial NCT05154994?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05154994 being conducted?

This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Urothelial Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05154994's enrollment target sits among peer trials

9 28th of 30 higher than 3 of 30 other Metastatic Urothelial Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05154994, the US trial registry maintained by the National Library of Medicine. NCT05154994 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.