Stage IV Pancreatic Cancer AJCC v8 Clinical Trial
Official title:
Phase II Trial of Lenvatinib-Pembrolizumab Maintenance Therapy in Patients With Advanced Unresectable Pancreatic Cancer
This phase II trial studies the effects of lenvatinib and pembrolizumab maintenance therapy in treating patients with pancreatic cancer that has spread to other places in the body (advanced) and cannot be removed by surgery (unresectable). Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenvatinib and pembrolizumab may be effective as a maintenance therapy in patients with pancreatic cancer.
PRIMARY OBJECTIVE: I. To evaluate the progression free survival (PFS) of lenvatinib mesylate (lenvatinib)-pembrolizumab as maintenance therapy in patients with advanced unresectable pancreatic cancer who have achieved partial response or stable disease following 1st or 2nd line therapy. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability associated with the combination of lenvatinib-pembrolizumab as maintenance therapy for patients with advanced unresectable pancreatic cancer. II. To evaluate the overall response rate (ORR), including confirmed and unconfirmed, complete and partial response and duration of response, of patients treated with lenvatinib-pembrolizumab in the subset of patients with measurable disease. III. To evaluate if potential gains in PFS translates into an overall survival (OS) benefit for patients with pancreatic cancer being treated with lenvatinib-pembrolizumab in the maintenance setting. EXPLORATORY OBJECTIVES: I .To investigate whether lenvatinib-pembrolizumab induces measurable immune-related systemic changes in peripheral blood over the course of therapy by flow cytometry using T cell markers (e.g. CD4+, CD8+, PD1, TIM-3, LAG-3, TOX nuclear factor). II. To conduct an exploratory study to identify global changes in expression of tumor-related genes using needle biopsy samples of PDA tumors obtained prior to and within one week after the 3rd cycle of pembrolizumab. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and lenvatinib mesylate orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then up to 1 year. ;
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