Research & Trial Information
Protocol#: Alliance – A031501
Cancer Type: Bladder
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract or LN+ disease. Variant histology allowed as long as urothelial carcinoma is predominant (any amount of squamous differentiation is allowed). Pure small-cell carcinoma is excluded.
- Paraffin tissue samples obtained by transurethral resection of muscle-invasive bladder tumor, upper tract resection, or radical cystectomy/nephrectomy/ureterectomy/nephroureterectomy must be available. This specimen submission is mandatory prior to registration as results will be used for stratification. Specimens from radical/definitive surgery (radical ystectomy/nephrectomy/ureterectomy/nephroureterectomy and LN dissection) are preferred over transuretheral resection, if available.
- Patient must fit into one of the following three categories: surgical resection is ≥ pT2 and/or N+Patients who received neoadjuvant chemotherapy and pathologic stage at OR Patients who are not cisplatin-eligible (according to ≥ 1 of the following criteria: ECOG performance status of 2, creatinine clearance < 60 mL/min, grade ≥ 2 hearing loss, grade ≥ 2 neuropathy, or New York Heart Association Class III heart failure ) and pathologic stage at surgical resection is ≥ pT3 or pN+) OR Patients that decline adjuvant cisplatin-based or other systemic chemotherapy based on an informed discussion with the physician and pathologic stage at surgical resection is ≥ pT3 or pN+.
- Patient must have had radical cystectomy, nephrectomy, nephroureterectomy or ureterectomy ≥4 weeks but ≤ 16 weeks prior to pre-registration.
- No gross cancer at the surgical margins. Microscopic invasive positive margins are allowed. CIS at margins is considered negative margins.
- No evidence of residual cancer or metastasis after surgery.
- No postoperative/adjuvant systemic therapy.
- No prior treatment with any therapy on the PD-1/PD-L1 axis.
- No treatment with any other type of investigational agent ≤ 4 weeks before preregistration.
- No major surgery ≤ 4 weeks before pre-registration.
- No radiation therapy ≤ 4 weeks before pre-registration.
- No neoadjuvant chemotherapy ≤ 4 weeks before pre-registration.
- Not currently requiring hemodialysis.
- Age ≥ 18 years
- ECOG Performance Status ≤ 2.
- Results of central PD-L1 testing available.