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

Conditions

• Metastatic Malignancy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Given by vein (IV)
• Tiragolumab — DRUG
  Given by vein (IV)

Study Details

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.

Key Dates

Start date

Feb 23, 2023

Status verified

Apr 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

10 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Atezolizumab
  Atezolizumab will be administered at a fixed dose of 1200 mg Q3W (1200 mg on Day 1 of each 21 day cycle),
• Experimental: Tiragolumab
  Tiragolumab will be administered at a fixed dose of 600 mg intravenously Q3W on Day 1 of each 21-day cycle.

Primary Outcome Measure

To evaluate relapse-free survival (RFS) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

• Padmanee Sharma, MD, PhD
  713-792-2830
  [email protected]

Locations (1)

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