Inclusion Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of locally advanced/unresectable
or mUC of the renal pelvis, ureter (upper urinary tract), bladder, or urethra.
- PD-1/L1 refractory locally advanced or mUC as evidenced by:
EITHER disease progression while on treatment or after treatment with an anti-PD-1/L1
monoclonal antibody (mAb) for locally advanced/unresectable or mUC administered either as
monotherapy, or in combination with other checkpoint inhibitors or other therapies OR
disease recurrence while on treatment or after treatment with an anti-PD-1/L1 mAb for
muscle-invasive urothelial carcinoma (MIUC) administered as monotherapy.
- Participants must provide an archival tumor tissue sample or newly obtained core or
excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and
adequate for biomarker evaluation.
Exclusion Criteria:
- Known additional nonurothelial malignancy that is progressing or has required active
treatment within 3 years prior to study randomization/allocation.
- Received prior systemic anticancer therapy including investigational agents within 4
weeks before randomization/allocation.
- Active infection requiring systemic therapy.
- Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines are allowed.
- Known history of human immunodeficiency virus (HIV).
- Known history of hepatitis B or known hepatitis C virus infection.