Spots Global Cancer Trial Database for Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma

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Trial Identification

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

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

Study ID: NCT05394337

Conditions

Metastatic Malignancy

Interventions

Atezolizumab

Tiragolumab

Study Description

Brief 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.