NCT05335941

A Phase 2 Study to Evaluate the Triplet Combination of Pemetrexed Plus AB928 (Etrumadenant) + AB122 (Zimberelimab) in Patients With Previously Treated Advanced or Metastatic MTAP Deficient Urothelial Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Urothelial Carcinoma
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed	Given by vein (IV)
DRUG	Zimberelimab	Given by vein (IV)
DRUG	Etrumadenant	Given by PO

Timeline

• Start date: 2023-06-13
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2022-04-20
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study