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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: Recruiting Phase 1 study of Metastatic Urothelial Carcinoma and Unresectable Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse events (AEs) will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Occurrence of DLTs along with count and percentage of subjects experiencing DLTs will be summarized. Safety of the combination regimen will be summarized by the number of adverse events as well as by the number and percentage of subjects experiencing the adverse events in both dose escalation and expansion cohorts. The safety summary will includ
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2025-05-05 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 1 |
What NCT06439836 shows while recruiting
NCT06439836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (79% lower).
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 lists 11 locations in 5 states (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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