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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: Recruiting Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by Emory University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be assessed by the Common Terminology Criteria for Adverse Events version 5.0.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-07-23 |
| Est. Completion | 2026-12-21 |
| Phase | Phase 1 |
What NCT04878029 shows while recruiting
NCT04878029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (75% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04878029's enrollment target sits among peer trials
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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.
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