Metastatic Pancreatic Ductal Adenocarcinoma
Conditions
Interventions
Experimental/Tiragolumab arm: Atezolizumab 840 mg and Tiragolumab 420 mg IV infusion on days 1 and 15 of each 28 day cycle. Nab-paclitaxel 125 mg/m2 and Gemcitabine 1000 mg/m2 IV infusion on days 1, 8
Sponsors
Shreya Badhrinarayanan, B.M.B.S.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma - no prior systemic treatment for PDAC - Life expectancy greater than or equal to 3 months - Availability of a representative tumor specimen that is suitable for determination of programmed death-ligand 1 (PD-L1) and/or additional biomarker status via central testing - Measurable disease (at least one target lesion) according to RECIST v1.1 - Adequate hematologic and end-organ function test results - Tumor accessible for biopsy - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as outlined for each specific treatment arm - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
Exclusion criteria
Exclusion criteria: - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage procedure (i.e., more than one time per month) - Symptomatic, untreated, or actively progressing central nervous system (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 on screening chest computed tomography (CT) scan - Positive human immunodeficiency (HIV) test at screening or at any time prior to screening - Active hepatitis B or C virus infection or active tuberculosis - Severe infection within 4 weeks prior to initiation of study treatment - Prior allogeneic stem cell or solid organ transplantation - History of malignancy other than pancreatic carcinoma within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, Efficacy Observation/Inspection, RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Efficacy Observation/Inspection, RECIST v1.1 | — |
Countries
Germany, Japan, South Korea, Spain, United States
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed