Metastatic Gastroesophageal Junction Adenocarcinoma Clinical Trial
Official title:
A Pilot Study of Pembrolizumab and Lenvatinib Combination Therapy in Patients With Previously Treated Advanced Gastroesophageal Adenocarcinoma
This early phase I trial studies the effect of pembrolizumab and lenvatinib in treating patients with gastroesophageal adenocarcinoma that has spread to other places in the body (advanced/metastatic) or cannot be removed by surgery (unresectable). 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. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and lenvatinib may kill more tumor cells.
PRIMARY OBJECTIVE: I. To estimate the overall response rate (ORR) of pembrolizumab plus lenvatinib by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in adult subjects with previously treated advanced (unresectable and/or metastatic) gastroesophageal adenocarcinoma. SECONDARY OBJECTIVES: I. To evaluate the duration of response (DOR), disease control rate (DCR), time-to-progression (TTP), progression-free survival (PFS), using RECIST 1.1 and immune-related (i)RECIST criteria and overall survival (OS). II. To determine the safety and tolerability of pembrolizumab plus lenvatinib in adult subjects with previously treated advanced (unresectable and/or metastatic) gastroesophageal adenocarcinoma. EXPPLORATORY OBJECTIVES: I. To perform exploratory biomarker analyses to study the correlation between immunological and molecular changes in tumor tissues and peripheral blood with clinical outcomes (DOR, DCR, TTP, PFS, and OS) using RESIST 1.1 and iRECIST. II. To explore the association between PD-L1 expression by immunohistochemistry (IHC), shed PD-L1 levels, somatic gene expression profiling (18-gene T-cell inflamed GEP) and antitumor efficacy of pembrolizumab based on RECIST 1.1 imaging criteria as well as OS. III. To explore the relationship between genomic variation and response to the treatment administered. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and lenvatinib orally (PO) once daily (QD). Treatment repeats every 42 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks. ;
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