Urothelial Cancer Clinical Trials

• Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures

• Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA

• At least 5mm of marker lesion left behind

• Participants must have previous genomic report or archival/fresh tissue in addition to urine sample for retrospective genomic testing

• Identification of marker lesion(s) within 8 weeks prior to randomization (refer to Inclusion Criterion #2)

• If synchronous NMIBC, NMIBC must be fully resected and low-grade Ta or T1

• No prior BCG administration within 1 year of date of consent.

• No intravesical chemotherapy within 8 weeks prior to C1D1 (including UGN-101).

• No systemic chemotherapy within 3 months prior to C1D1

⁃ ECOG 0-2

⁃ Pathology consists of pure urothelial carcinoma

⁃ Adequate bone marrow, liver, and renal function:

∙ i. Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL

‣ i. Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN

‣ Estimated glomerular filtration rate \>60 mL/min

‣ Serum Phosphate level ≤ ULN prior to starting treatment

‣ International normalized ratio (INR) ≤1.5 × ULN