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Recruiting Phase 2 NCT04887805

Lenvatinib and Pembrolizumab Maintenance Therapy for the Treatment of Patients of Advanced Unresectable Pancreatic Cancer

Trial Parameters

Condition Advanced Pancreatic Ductal Adenocarcinoma
Sponsor City of Hope Medical Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 28
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-07-21
Completion 2026-11-05
Interventions
Lenvatinib MesylatePembrolizumab

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Documented informed consent by the participant * Willingness to provide tissue and blood samples for correlative studies * Age: \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 * Must have a confirmed histologic or cytologic diagnosis of advanced unresectable pancreatic ductal adenocarcinoma (PDA) * Must have received at least 16 weeks of 1st or 2nd line therapy and achieved partial response or stable disease (by computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) with no signs of progression within 30 days before start of treatment * Last chemotherapy treatment must be within 30 days prior to start of treatment * No prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) * Measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. Lesions situ

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