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NCT04963153 · ClinicalTrials.gov registry record · Phase 1

Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy

A Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
24
Enrollment target
10
Study locations

NCT04963153 is a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (82% lower). The trial reports 10 study locations across 9 states.

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The verdict

NCT04963153, a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
10
Study locations

Study Summary

This phase Ib trial evaluates the best dose, potential benefits, and/or side effects of erdafitinib in combination with enfortumab vedotin in treating patients with bladder cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and possesses genetic alterations in FGFR2/3 genes. Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. This may help keep cancer cells from growing and may kill them. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Giving erdafitinib in combination with enfortumab vedotin may shrink or stabilize metastatic bladder cancer with alterations in FGFR 2/3 genes.

Conditions Studied

Metastatic Urothelial Carcinoma Locally Advanced Urothelial Carcinoma Metastatic Bladder Urothelial Carcinoma Locally Advanced Bladder Urothelial Carcinoma Metastatic Ureter Urothelial Carcinoma Metastatic Urethral Urothelial Carcinoma Locally Advanced Ureter Urothelial Carcinoma Metastatic Renal Pelvis Urothelial Carcinoma Locally Advanced Renal Pelvis Urothelial Carcinoma Locally Advanced Urethral Urothelial Carcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Enfortumab Vedotin
  • PROCEDURE Bone Scan
  • PROCEDURE Echocardiography Test

Study Locations (10)

California

  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles

Colorado

  • UCHealth University of Colorado Hospital - Aurora

Florida

  • Moffitt Cancer Center - Tampa

New York

  • NYP/Weill Cornell Medical Center - New York

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Pennsylvania

  • University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh

Texas

  • UT Southwestern/Simmons Cancer Center-Dallas - Dallas

Utah

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

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2022-07-07
Est. Completion 2026-12-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04963153

The ClinicalTrials.gov registry entry for NCT04963153 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 24 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 (82% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT04963153 reports 10 study locations spanning 9 distinct geographic areas - top geographies include California, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT04963153 about?

NCT04963153 is a clinical study titled "Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy". This phase Ib trial evaluates the best dose, potential benefits, and/or side effects of erdafitinib in combination with enfortumab vedotin in treating patients with bladder cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and possesses geneti...

What is the current status of trial NCT04963153?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-07-07. Estimated completion is 2026-12-01.

What conditions does trial NCT04963153 study?

This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma.

What interventions are being tested in trial NCT04963153?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Enfortumab Vedotin (DRUG), Bone Scan (PROCEDURE), Echocardiography Test (PROCEDURE).

Who is sponsoring clinical trial NCT04963153?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04963153 being conducted?

This trial has 10 study locations across California, Colorado, Florida, New York, Ohio. 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.