Brief Title: RO7247669 Alone or in Combination With Tiragolumab vs Atezolizumab in Participants With Untreated Locally Advanced or Metastatic Urothelial Cancer

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: Up to approximately 30 months

CONDITION

• Urothelial Cancer

ELIGIBILITY

Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2

- Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium

- Ineligible ("unfit") to receive platinum-based chemotherapy

- No prior chemotherapy for inoperable locally advanced or metastatic or recurrent urothelial carcinoma (UC)

- Measurable disease; at least one measurable lesion as defined by response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1)

- Availability of a representative leftover tumor specimen that is suitable for determination of PD-L1 status as assessed by a central laboratory

- Adequate hematologic and end organ function

- Negative for hepatitis B and hepatitis C virus (HCV)

- Adequate cardiovascular function
Exclusion Criteria:
Pregnancy or breastfeeding

- GFR <15 mL/min/1.73 m2 - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - History of leptomeningeal disease - Uncontrolled tumor-related pain - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures - Uncontrolled or symptomatic hypercalcemia - 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 on screening chest computed tomography (CT) scan - Active tuberculosis (TB) or Epstein-Barr virus (EBV) - Significant cardiovascular/cerebrovascular disease within 3 months prior to initiation of study treatment - Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study - History of another primary malignancy other than urothelial carcinoma within 5 years prior to Cycle 1, Day 1, with the exception of malignancies with a negligible risk of metastasis or death - Severe infection within 4 weeks prior to initiation of study treatment - Treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment - Prior allogeneic stem cell or solid organ transplantation - Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment or within 5 months after the final dose of atezolizumab, 4 months after the final dose of RO7247669, or 90 days after the final dose of tiragolumab - Current treatment with anti-viral therapy for HBV - Treatment with any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment - Treatment with investigational therapy within 28 days prior to initiation of study treatment - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-TIGIT and anti-LAG3 therapeutic antibodies or pathways targeting agents - Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment - Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment - History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Clinical Trials

Role: Study Director

Affiliation: Hoffmann-LaRoche

Overall Contact

Name: Clinical Trials

Phone: 888-662-6728

Email: global-roche-genentech-trials@gene.com

LOCATION