Gastric Adenocarcinoma Clinical Trial
Official title:
A Phase II Study of Lenvatinib, a Multi-Targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies
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.
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.
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