None listed
Conditions
Interventions
(1)Dosage form:
MPDL3208A: Vial, MPDL3280A, 1200 mg/20 mL (concentration: 60 mg/ml) solution for I.V.
Bevacizumab: Vial, Bevacizumab 400 mg/16 ml (concentration: 25 mg/ml) solution for I.V.
(
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: • Signed Informed Consent Form • Male or female, 18 years of age or older • ECOG performance status of 0 or 1 • Histologically or cytologically confirmed, Stage IV non-squamous NSCLC • No prior treatment for Stage IV non-squamous NSCLC • Patients with a history of treated asymptomatic central nervous system (CNS) metastases are eligible. • Known PD-L1 tumor status as determined by an IHC assay performed by a central laboratory on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening • Measurable disease, as defined by RECIST v1.1 • Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to randomization. • For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: Cancer-Specific Exclusions • Active or untreated CNS metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >2 weeks prior to randomization • Leptomeningeal disease • Uncontrolled tumor-related pain • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) • Uncontrolled or symptomatic hypercalcemia (>1.5 mmol/L ionized calcium or Ca >12 mg/dL or corrected serum calcium >ULN) • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death. General Medical Exclusions • Women who are pregnant, lactating, or intending to become pregnant during the study • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins • Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the MPDL3280A formulation • History of autoimmune disease. • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan • Positive test for HIV • Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C • Active tuberculosis • Severe infections within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia • Received therapeutic oral or IV antibiotics within 2 weeks prior to randomization. • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina • Major surgical procedure other than for diagnosis within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study • Prior allogeneic bone marrow transplantation or solid organ transplant • Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications Exclusion Criteria Related to Medications • Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment. • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to randomization • Prior treatment with CD137 agonists or immune checkpoint bl
Countries
Australia, Austria, Belgium, Brazil, Bulgaria, Canada, France, Germany, Italy, Japan, Lithuania, Netherlands, Portugal, Russian Federation, Singapore, Spain, Switzerland, Turkey, Ukraine, United States
Contacts
Public ContactAndres Cesar Martin Bayona
PPD Peru S.A.C.
Outcome results
None listed