A solid tumor/cancer is an abnormal tissue mass that arises from uncontrolled growth of cells and continues to grow locally or spread to other parts of the body (metastatic).
Conditions
Interventions
Ventana PD-L1 SP142 assay, Ventana PD-L1 SP263 assay
Sponsors
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Life expectancy >= 12 weeks - Adequate hematologic and end-organ function - Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy - Availability of representative tumor specimens - Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of RO7501275, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab (whichever is longer). - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - History of leptomeningeal disease - Significant cardiovascular disease within 3 months prior to initiation of study treatment - History of malignancy other than disease under study within 3 years prior to screening - Any immune-mediated adverse events related to prior cancer immunotherapy that have not resolved completely to baseline - Active or history of autoimmune disease or immune deficiency - Active tuberculosis, hepatitis B or acute or chronic active EBV infection - Positive test for human immunodeficiency virus (HIV) infection - Positive hepatitis C virus (HCV) antibody test - Known infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) - Major surgical procedure or significant traumatic injury within 28 days prior to first study drug infusion - Prior allogeneic stem cell or organ transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of the study is to determine PD-L1 expression of potential study subjects to be used for enrollment of all Expansion Cohorts in study GO43860. The clinical performance of the PD-L1 assays is not under investigation in the context of the pharmaceutical study endpoints. | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Netherlands
Contacts
Public ContactF. F. Hoffmann-La Roche
Hoffmann-La Roche
Outcome results
None listed