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Sponsor: Hoffmann-La Roche
Conditions: Pancreatic Adenocarcinoma
Interventions: Nab-Paclitaxel, Gemcitabine, Oxaliplatin, Leucovorin, Fluorouracil
Countries: United States, Germany, Japan, South Korea, Spain
A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of patients who have received one line of prior systemic therapy for PDAC. In each cohort, eligible patients will be assigned to one of several treatment arms.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma * For patients in Cohort 1: no prior systemic treatment for PDAC * For patients in Cohort 2: disease progression during administration of either 5-FU- or gemcitabine-based first-line chemotherapy * 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: * 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
- Duarte, California, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- New York, New York, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Milwaukee, Wisconsin, United States
- Essen, Germany
- Chiba, Japan
- Kanagawa, Japan
- Tokyo, Japan
- Seoul, South Korea
- Seoul, South Korea
- Seoul, South Korea
- Pamplona, Navarre, Spain
- Barcelona, Spain
- Madrid, Spain
- Madrid, Spain