Pre-Registration Eligibility Criteria
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, urethra, upper tract, or LN+ disease. Variant histology allowed as long as urothelial carcinoma is predominant (any amount of squamous differentiation is allowed). Any component of neuroendocrine carcinoma is excluded.
- Patient must have had radical cystectomy (cystoprostatectomy for men) and lymph node dissection (for bladder primary), or nephrectomy, nephroureterectomy or ureterectomy (for uppertract tumors) or urethrectomy (in addition to a radical cystectomy-either simultaneously or in the past) ≥4 weeks but ≤ 16 weeks prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible.
- No evidence of residual cancer or metastasis after surgery.
- No metastatic disease (or radiologic findings "concerning" for metastatic disease) on cross-sectional imaging.
- 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 pre-registration
- No major surgery ≤ 4 weeks before pre-registration
- No radiation therapy ≤ 4 weeks before pre-registration
- No neoadjuvant chemotherapy ≤ 4 weeks before pre-registration
- Age ≥ 18 years
- ECOG Performance Status ≤ 2
Please contact Legacy Oncology Research for additional study inclusion/exclusion information.