NCT05394337

Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if the combination of atezolizumab and tiragolumab can help to control bladder cancer when it is given before surgery to remove the bladder and tumor.

Detailed description

Primary Safety Objective: •To evaluate the safety and tolerability oftiragolumab and atezolizumab in patients with muscle-invasive, high-risk UC who are ineligible for neoadjuvant cisplatin-containing chemotherapies. Secondary Efficacy Objectives: * To evaluate pathologic T0 rate after neoadjuvant treatment with tiragolumab and atezolizumab in patients with muscle-invasive, high-risk UC comparing to historical data (about 10% in patients with high-risk disease). * To evaluate relapse-free survival (RFS) and overall survival (OS). Exploratory Biomarker Objective : • To assess immunologic/molecular responses to tiragolumab and atezolizumab in patients with muscleinvasive, high-risk UC who are ineligible for neoadjuvant cisplatin-containing chemotherapies.

Conditions

• Metastatic Malignancy

Interventions

Type	Name	Description
DRUG	Atezolizumab	Given by vein (IV)
DRUG	Tiragolumab	Given by vein (IV)

Timeline

• Start date: 2023-02-23
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-05-27
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study