Urothelial Cancer Clinical Trials

• Participant must be \> 18 years of age at the time of signing the ICF.

• Histologically confirmed MIUC of the bladder or upper tract.

• Completed R0 radical resection 28 to 120 days before randomisation, with negative margins and no residual or metastatic disease.

• Pathologic evidence of urothelial carcinoma at high-risk of recurrence and

‣ not received neoadjuvant therapy and has pT3-pT4aN0, or any pT with pN+ stage

⁃ completed neoadjuvant treatment and has ypT2-ypT4a, or any ypT with ypN+ stage

• No evidence of disease at screening,

• ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation.

• Minimum life expectancy of \> 12 weeks at time of screening.

• An archival surgical tumour sample must be available pre-randomisation for central testing.

• Adequate organ and bone marrow function within 28 days before randomisation.