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NCT06439836 · ClinicalTrials.gov registry record · Phase 1

Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy

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

Recruiting
Registry status
Phase 1
Development phase
27
Enrollment target
11
Study locations

NCT06439836 is a Phase 1 study of Metastatic Urothelial Carcinoma and Unresectable Urothelial Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (79% lower). The trial reports 11 study locations across 5 states.

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The verdict

NCT06439836, a Phase 1 study of Metastatic Urothelial Carcinoma and Unresectable Urothelial Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
27 participants
Enrollment target
11
Study locations

Study Summary

This phase I trial tests the safety, side effects, best dose, and effectiveness of emavusertib (CA-4948) in combination with pembrolizumab in treating patients with urothelial cancer that has spread from where it first started to other places in the body (metastatic) and that has a resistance to PD-1/PD-L1 immune checkpoint inhibitors. CA-4948, a kinase inhibitor, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving CA-4948 in combination with pembrolizumab may be safe, tolerable and/or effective in treating patients with metastatic urothelial cancer that is resistant to PD-1/PD-L1 immune checkpoint inhibitors.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Biopsy Procedure
  • BIOLOGICAL Emavusertib

Study Locations (11)

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
  • UC San Diego Moores Cancer Center - La Jolla
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange

Georgia

  • Emory University Hospital Midtown - Atlanta
  • Emory University Hospital/Winship Cancer Institute - Atlanta
  • Emory Saint Joseph's Hospital - Atlanta

New York

  • Mount Sinai Hospital - New York
  • NYP/Weill Cornell Medical Center - New York

Florida

  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami

Texas

  • UT Southwestern/Simmons Cancer Center-Dallas - Dallas

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2025-05-05
Est. Completion 2027-06-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT06439836

The ClinicalTrials.gov registry entry for NCT06439836 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 27 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 (79% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06439836 reports 11 study locations spanning 5 distinct geographic areas - top geographies include California, Georgia, New York.

Frequently Asked Questions

What is clinical trial NCT06439836 about?

NCT06439836 is a clinical study titled "Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy". This phase I trial tests the safety, side effects, best dose, and effectiveness of emavusertib (CA-4948) in combination with pembrolizumab in treating patients with urothelial cancer that has spread from where it first started to other places in the body (metastatic) and that has a resistance to PD-...

What is the current status of trial NCT06439836?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2025-05-05. Estimated completion is 2027-06-01.

What conditions does trial NCT06439836 study?

This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma.

What interventions are being tested in trial NCT06439836?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Emavusertib (BIOLOGICAL).

Who is sponsoring clinical trial NCT06439836?

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

Where is trial NCT06439836 being conducted?

This trial has 11 study locations across California, Florida, Georgia, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.