Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma
M.D. Anderson Cancer Center
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.
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/m…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed Informed Consent Form 2. Age \>18 years at time of signing Informed Consent Form 3. Ability to comply with the study protocol 4. Histologically or cytologically confirmed proof of muscle invasive urothelial cancer. This may include any patient requiring cystectomy (or nephroureterectomy to resect tumors), including muscle invasive disease (cT2-4aN0M0). Patients with the following high-risk features who are not candidates for traditional neoadjuvant chemotherapy will be included for this trial: micropapillary, sarcomatoid and plasmacytoid features; 3-D mass on exa…
Interventions
- DrugAtezolizumab
Given by vein (IV)
- DrugTiragolumab
Given by vein (IV)
Location
- M D Anderson Cancer CenterHouston, Texas