Actively Recruiting
Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
10
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age over 18 years at time of consent
- Ability to follow study procedures
- Confirmed muscle invasive urothelial cancer requiring bladder or tumor removal surgery
- High-risk tumor features such as micropapillary, sarcomatoid, plasmacytoid, lymphovascular invasion, or hydronephrosis
- Considered ineligible for cisplatin chemotherapy or refused cisplatin-based neoadjuvant therapy
- Transurethral resection of bladder tumor tissue performed at MD Anderson or within 3 months with tissue available for research
- Eligible for complete tumor removal surgery with curative intent
- Adequate lung function as assessed by pulmonary tests within 6 months
- ECOG performance status of 0 or 1
- Normal life expectancy excluding lung cancer risk
- Adequate blood counts and organ function based on recent laboratory tests
- Negative tests for HIV, hepatitis B and C
- Women of childbearing potential agree to abstain or use effective contraception during and after treatment
- Men agree to abstain or use condoms and refrain from sperm donation during and after treatment
You will not qualify if you...
- Any condition interfering with ability to follow study procedures
- Prior treatment for urothelial cancer including immunotherapy, chemotherapy, or radiation
- History of leptomeningeal disease
- Active or history of autoimmune diseases except controlled hypothyroidism, controlled type 1 diabetes, or limited skin conditions meeting specific criteria
- History or evidence of lung inflammation or pneumonitis
- Active tuberculosis
- Significant recent cardiovascular disease
- Major surgery within 4 weeks before study treatment
- History of other malignancies within 5 years except certain low-risk cancers
- Severe infection within 4 weeks before study treatment
- Recent therapeutic antibiotic treatment within 2 weeks
- Prior stem cell or organ transplantation
- Conditions or lab findings contraindicating investigational drugs
- Recent live vaccine administration
- Current antiviral treatment for hepatitis B
- Positive Epstein-Barr virus IgM or PCR test
- Recent treatment with other investigational drugs or immune therapies
- Recent systemic immunostimulatory or immunosuppressive medication use with exceptions
- Severe allergic reactions to similar antibodies
- Known allergy to study drug components
- Pregnancy, breastfeeding, or intention to become pregnant during and shortly after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Padmanee Sharma, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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