Solid Tumor
Conditions
Interventions
investigational material(s)
Generic name etc : Atezolizumab
INN of investigational material : Atezolizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investig
Sponsors
Chugai Pharmaceutical Co., Ltd.
F. Hoffmann-La Roche, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Measurable disease per RECIST v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate hematologic and end organ function - Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade less than or equal to (</=) 1 prior to study entry, with the exception of alopecia - Ready to use reliable contraceptive procedures
Exclusion criteria
Exclusion criteria: - Uncontrolled pleural effusion, pericardial effusion, or ascites - Uncontrolled tumor-related pain - Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy - Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases - Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or other recombinant human antibodies - Positive test for Human Immunodeficiency Virus (HIV) - Active tuberculosis - Severe infections within 4 weeks prior to Day 1 - Signs or symptoms of significant infection within 2 weeks prior to Day 1 - Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1 - Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to Day 1, unstable arrhythmias, or unstable angina - History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to Day 1 - Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study - Any serious medical condition or abnormality in clinical laboratory tests that, in the investigators judgment, precludes the participants safe participation in and completion of the study - Malignancies other than pancreatic carcinoma within 2 years prior to study start, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS >90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)"
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Observation, RECIST ver1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics other other(Anti-Therapeutic Antibodies) Observation, RECIST ver1.1, immune-modified RECIST | — |
Countries
Asia except Japan, Japan, North America, Oceania
Outcome results
None listed