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 or upper tract.
- Paraffin tissue available for PD-L1 analysis.
- 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
• 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+ .
- Radical resection of bladder cancer ≤16 weeks prior to preregistration.
- No evidence of residual cancer or mets after surgery.
- No measurable disease on cross-sectional imaging.
- No active autoimmune disease or history of autoimmune disease that may recur.
- No postoperative/adjuvant systemic therapy.
- No prior treatment with any therapy on the PD-1 Or PD-L1 axis.
- No, treatment with an investigational agent, major surgery,
radiation therapy or neoadjuvant chemotherapy ≤4 weeks prior to pre-registration.
- Age ≥18 years.
Registration Eligibility Criteria:
- Central PD-L1 results available.