Research & Trial Information
Protocol #: A031501
Cancer Type: GU Bladder
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract. Variant histology allowed as long as urothelial carcinoma is predominant (>50%). Pure small-cell carcinoma is excluded.
- Paraffin tissue samples obtained by transurethral resection of muscle-invasive bladder tumor, upper tract resection, cystectomy/nephrectomy/ureterectomy, or nephroureterectomy must be available. This specimen submission is mandatory prior to registration as results will be used for stratification. See Section 6.2 for details on specimen submission.
- Patient must fit into one of the following three categories:• Patients who received neoadjuvant chemotherapy and pathologic stage at surgical resection is ≥ pT2 and/or N+
• 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+)
• 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 surgical resection of their bladder cancer ≥4 weeks but ≤ 16 weeks prior to pre-registration. No invasive cancer at the surgical margins. No evidence of residual cancer or metastasis after surgery.
- No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids.
- No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years.
- Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
- Patients with rheumatoid arthritis and other arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
- 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