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NCT04878029 · ClinicalTrials.gov registry record · Phase 1

Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer

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

Recruiting
Registry status
Phase 1
Development phase
32
Enrollment target
1
Study location

NCT04878029 is a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma that is actively recruiting participants, run by Emory University. The registered enrollment target is 32 participants, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04878029, a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, is actively recruiting participants, sponsored by Emory University.

RECRUITING
Registry status
Phase 1
Development phase
32 participants
Enrollment target
1
Study location

Study Summary

This phase I/Ib trial seeks to find out the best dose, possible benefits and/or side effects of cabozantinib in combination with enfortumab vedotin in treating urothelial cancer that has spread to nearby tissues and lymph nodes (locally advanced) or other parts of the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to a toxic agent called vedotin. Enfortumab attaches to nectin-4 tumor cells in a targeted way and delivers vedotin to kill them. Cabozantinib in combination with enfortumab vedotin may be safe and effective in treating locally advanced or metastatic urothelial cancer.

Conditions Studied

Metastatic Urothelial Carcinoma Locally Advanced Urothelial Carcinoma Unresectable Urothelial Carcinoma Infiltrating Bladder Urothelial Carcinoma With Squamous Differentiation

Interventions

  • OTHER Quality-of-Life Assessment
  • DRUG Enfortumab Vedotin
  • DRUG Cabozantinib S-malate
  • OTHER Questionnaire Administration

Study Locations (1)

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2021-07-23
Est. Completion 2026-12-21
Phase Phase 1

Sponsor

Emory University

1,208 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04878029

The ClinicalTrials.gov registry entry for NCT04878029 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (75% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

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

NCT04878029 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT04878029 about?

NCT04878029 is a clinical study titled "Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer". This phase I/Ib trial seeks to find out the best dose, possible benefits and/or side effects of cabozantinib in combination with enfortumab vedotin in treating urothelial cancer that has spread to nearby tissues and lymph nodes (locally advanced) or other parts of the body (metastatic). Cabozantinib...

What is the current status of trial NCT04878029?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2021-07-23. Estimated completion is 2026-12-21.

What conditions does trial NCT04878029 study?

This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Unresectable Urothelial Carcinoma, Infiltrating Bladder Urothelial Carcinoma With Squamous Differentiation.

What interventions are being tested in trial NCT04878029?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Enfortumab Vedotin (DRUG), Cabozantinib S-malate (DRUG), Questionnaire Administration (OTHER).

Who is sponsoring clinical trial NCT04878029?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04878029 being conducted?

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

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.