Clinical Trial Information
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or EUA. The diagnostic TURBT sample must have been obtained within 60 days prior to registration.
- Clinical stage T2-T4aN0/xM0 disease.
- Medically appropriate candidate for radical cystectomy as assessed by surgeon.
- No concomitant multifocal carcinoma in situ; a single focus is allowed.
- One focus of muscle-invasive bladder cancer and/or a tumor <5 cm in size.
- No clinical or radiographic evidence for locally advanced or metastatic disease.
- No prior anti-PD-1, anti PD-L1 therapies, or systemic chemotherapy (prior intravesical induction immunotherapy for non-muscle invasive disease is allowed, defined as BCG x6 treatments; BCG refractory disease, defined as disease recurrence within 3 months of BCG therapy, is not allowed).
- No prior radiation therapy to the bladder.
- No major surgery or radiation therapy <4 weeks of registration.
- Age ≥ 18 years.
- ECOG Performance Status 0-1.