Protocol: Alliance A031701
Please Note: Below is a partial list of eligibility, please contact GHCI Research Department for full eligibility requirements. Thank you!
Eligibility:
- 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.
- A single muscle-invasive bladder tumor measuring ≤5 cm in size as defined by the surgeons at cystoscopic evaluation. When documented, pathologic size at
cystoscopy and TURBT will take precedence over radiographic measurements of tumor size. - No clinical or radiographic evidence for locally advanced or metastatic disease.
- No prior anti-PD-1 or anti PD-L1 therapies, or systemic chemotherapy within the past 5 years (prior intravesical induction immunotherapy for non-muscle invasive
disease is allowed, defined as BCG x6 doses and maintenance therapy); BCG refractory disease, defined as disease recurrence within 3 months of BCG therapy,
is not allowed. Intravesical chemotherapy is allowed. - No prior radiation therapy to the bladder or prostate.
- Age ≥ 18 years.
- ECOG Performance Status 0-1.