Primary Outcomes:

Primary Outcome 1 - Measure: Objective Response Rate (ORR)

Primary Outcome 1 - Time Frame: Baseline until disease progression or loss of clinical benefit (approximately 4 years)

Condition:

• Urothelial Carcinoma

Eligibility

Criteria:
Inclusion Criteria:

- Histologically documented, locally advanced or metastatic UC (also termed TCC or
urothelial cell carcinoma of the urinary tract; including renal pelvis, ureters,
urinary bladder, and urethra)

- Availability of a representative tumor specimen that is suitable for determination of
PD-L1 and/or additional biomarker status by means of central testing

- Disease progression during or following treatment with no more than one
platinum-containing regimen for inoperable, locally advanced or metastatic UC or
disease recurrence

- ECOG Performance Status of 0 or 1

- Measurable disease (at least one target lesion) according to RECIST v1.1

- Adequate hematologic and end-organ function

- Negative HIV test at screening

- Negative total hepatitis B core antibody (HBcAb) test and hepatitis C virus (HCV)
antibody at screening

- Tumor accessible for biopsy

- For women of childbearing potential: agreement to remain abstinent or use
contraceptive measures and agreement to refrain from donating eggs

- For men: agreement to remain abstinent or use contraceptive measures, and agreement to
refrain from donating sperm

Exclusion Criteria:

- Prior treatment with a T-cell co-stimulating therapy or a CPI including anti-CTLA-4,
anti-PD-1, and anti-PD-L1 therapeutic antibodies

- Prior treatment with any of the protocol-specified study treatments including
treatment with poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor,
nectin-4 targeting agents, signal regulatory protein alpha-targeting agents, or agents
that block CD38

- Treatment with investigational therapy within 28 days prior to initiation of study
treatment

- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3
weeks prior to initiation of study treatment

- Eligibility only for the control arm

- Prior allogeneic stem cell or solid organ transplantation

- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the
drug (whichever is longer) prior to the initiation of study treatment

- Treatment with systemic immunosuppressive medication within 2 weeks prior to
initiation of study treatment or anticipation of need for systemic immunosuppressant
medication during study treatment

- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study
treatment, or anticipation of need for such a vaccine during atezolizumab treatment or
within 5 months after the last dose of atezolizumab

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures

- Uncontrolled tumor-related pain

- Uncontrolled or symptomatic hypercalcemia

- Symptomatic, untreated, or actively progressing CNS metastases

- History of leptomeningeal disease

- Active or history of autoimmune disease or immune deficiency

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis

- History of malignancy other than UC within 2 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death

- Active tuberculosis

- Severe infection within 4 weeks prior to initiation of study treatment

- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation
of study treatment

- Significant cardiovascular disease

- Grade 3 or greater hemorrhage or bleeding event within 28 days prior to initiation of
study treatment

- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation
of study treatment

- Pregnancy or breastfeeding, or intention of becoming pregnant during the study

- Additional drug-specific exclusion criteria might apply
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No