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Clinical Trial Summary

This phase II trial studies how well lenvatinib mesylate works with pembrolizumab in treating patients with gastric or gastroesophageal cancer that has spread to other places in the body or has come back. Lenvatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving lenvatinib mesylate and pembrolizumab may work better at treating at gastric or gastroesophageal cancer.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the overall response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for the combination of lenvatinib mesylate (lenvatinib) and pembrolizumab in patients with metastatic gastroesophageal cancer who have progressed on first or subsequent line(s) therapies.

SECONDARY OBJECTIVES:

I. To determine the progression free survival (PFS), overall survival (OS), and toxicity rates in advanced gastroesophageal patients treated with lenvatinib and pembrolizumab.

TERTIARY OBJECTIVES:

I. To characterize changes in the immune cell phenotype, immune pathway activity, and immune response following lenvatinib only, and then with the addition of pembrolizumab.

OUTLINE:

Patients receive lenvatinib mesylate orally (PO) on days 1-7 of course 1, then on days 1-21 of subsequent courses. Patients also receive pembrolizumab intravenously (IV) over 30 minutes on day 8 of course 1, then on day 1 of subsequent courses. Courses 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 every 9 and 12 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03413397
Study type Interventional
Source New York University School of Medicine
Contact Benson Joseph
Phone 212-731-5076
Email Benson.Joseph@nyumc.org
Status Recruiting
Phase Phase 2
Start date November 8, 2017
Completion date November 2021

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