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Clinical Trial Summary

This is a Phase 2 open-label, single-arm trial for patients with MTAP-deficient advanced urothelial cancer who had received prior immunotherapy. This is a single site study at the University of Texas MD Anderson Cancer Center. This study will allow patients in second line of treatment for advanced urothelial ca or beyond. All patients must have been previously treated with immune checkpoint inhibitor (ICI) therapy as per current standard of care.


Clinical Trial Description

Objectives: Primary Objectives: - To evaluate the safety and tolerability of the triplet combination regimen. - To evaluate the clinical activity of the triplet combination regimen. Secondary Objectives: - To explore the biological changes in MTAP-deficient UC tumor microenvironment including peripheral T-cells, tumor-infiltrating T-cells, macrophages, and myeloid-derived suppressor cell (MDSCs) Exploratory objective: - To evaluate survival of patients treated with triplet combination regimen. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05335941
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Omar Alhalabi, MD
Phone 713-745-2740
Email OAlhalabi@mdanderson.org
Status Recruiting
Phase Phase 2
Start date June 13, 2023
Completion date September 30, 2025

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