Neoadjuvant Nivolumab for Upper Tract Urothelial Carcinoma

Inclusion criteria

• . Have a histologically or clinically confirmed diagnosis of locally advanced (cT2-T4 and N0M0) urothelial carcinoma of the renal pelvis and/or ureter (UTUC). Pure urothelial carcinoma or urothelial carcinoma mixed with other histological variant are allowed, but urothelial carcinoma must be the predominant histology.
• . Have at least a measurable lesion based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
• . Voluntarily agree to participate by providing written informed consent/assent for the trial.
• . Age (at the time of informed consent): 20 years and older
• . Have received no prior systemic chemotherapy for advanced urothelial carcinoma, with the following exceptions:
• . Platinum-based chemotherapy for previous a history of ipsilateral UTUC or bladder cancer in purpose of neoadjuvant or adjuvant treatment with recurrence \> 6 months from completion of therapy is permitted.
• . Low-dose chemotherapy (e.g., low-dose cisplatin, cisplatin plus 5-FU, mitomycin plus 5-FU, or cisplatin plus paclitaxel) given concurrently with radiation to urothelial carcinoma of bladder is not considered systemic therapy.
• . Have willing to provide tissue for exploratory biomarker analysis from a newly obtained core or excisional biopsy of a tumor lesion from the renal pelvis or ureter tumor.

Exclusion criteria