| Eligibility |
Inclusion Criteria:
1. Histologically or cytologically confirmed,locally advanced(T4b,any N or any T,N2-3 or
metastatic carcinoma(including renal pelvic, ureter bladder and urethra);
2. Cohort 1:Patients with First-line platinum ineligible must meet criteria for either
option a or option b (below):
1. Has a tumor(s) with PD-L1 combined positive and is considered ineligible to
receive cisplatin-based combination therapy, based on 1 of the following:
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 2
within 7 days prior to randomization
- National Cancer Institute (NCI) Common Terminology Criteria for Adverse
Events (CTCAE) Version 5.0 Grade =2 audiometric hearing loss
- NCI CTCAE Version 5.0 Grade =2 peripheral neuropathy OR
2. In the opinion of the investigator, is considered ineligible to receive any
platinum-based chemotherapy (i.e., ineligible for cisplatin and carboplatin)
based on:
- ECOG PS of 2 within 7 days prior to randomization. and =1 of the following:
- Documented visceral metastatic disease
- NCI CTCAE Version 5.0 Grade =2 audiometric hearing loss
- NCI CTCAE Version 5.0 Grade =2 peripheral neuropathy
Cohort 2: Inoperable Patients in sencond line(or beyond)with locally advanced or metastatic
urothelial carcinoma who have disease recurrence or progression during or after a
platinum-based chemotherapy regimen;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
- Calculated creatinine clearance = 30 milliliter (mL)/min (Cockcroft-Gault formula)
Exclusion Criteria:
1. Has received prior therapy with an anti-PD-1, anti-PD-L1 agent or with CTLA-4
receptor;
2. Has a known hypersensitivity to anti-PD-1 / PD-L1 agent;
3. Known pia meningeal metastasis or active central nervous system (CNS) metastasis
revealed by CT or MRI. Participants with asymptomatic brain metastases may participate
without evidence of progression for at least 1 month.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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