Primary Outcomes:

Primary Outcome 1 - Measure: Phase 1b: Percentage of Participants with Dose-Limiting Toxicity (DLT)

Primary Outcome 1 - Time Frame: Approximately up to 8 weeks

Primary Outcome 2 - Measure: Phase 1b: Number of Participants with Adverse Events (AEs)

Primary Outcome 2 - Time Frame: Approximately up to 2 years

Primary Outcome 3 - Measure: Phase 2: Overall Response Rate (ORR) (Partial Response [PR] or Better) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment

Primary Outcome 3 - Time Frame: Approximately up to 2 years

Primary Outcome 4 - Measure: Phase 2: Number of Participants with AEs

Primary Outcome 4 - Time Frame: Approximately up to 2 years

Condition:

• Urothelial Carcinoma

Eligibility

Criteria:
Inclusion Criteria:

- Histologic demonstration of transitional cell carcinoma of the urothelium. Variant
urothelial carcinoma histologies such as glandular or squamous differentiation, or
evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change
are acceptable

- Metastatic or locally advanced urothelial cancer

- Must have measurable disease by radiological imaging according to the Response
Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline

- Prior systemic therapy for metastatic urothelial cancer: (a) Phase 1b: Any number of
lines of prior therapy; (b) Phase 2: No prior systemic therapy for metastatic disease
and cisplatin-ineligible

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: 0, 1, or 2

Exclusion Criteria:

- Treatment with any other investigational agent or participation in another clinical
study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b,
participants who have received the following prior antitumor therapy: received
nitrosoureas and mitomycin C within 6 weeks

- Chemotherapy within 3 weeks of Cycle 1 Day 1

- Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1),
or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant
checkpoint inhibitor therapy is allowed if the last dose was given more than (>)12
months prior to recurrent disease progression and did not result in drug-related
toxicity leading to treatment discontinuation

- Active malignancies requiring concurrent therapy other than urothelial cancer

- Symptomatic central nervous system metastases
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No