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Clinical Trial 19207
Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT03290079
Phase: Phase II
Prinicipal Investigator: Jonathan Strosberg
Study Title
Phase II study of pembrolizumab and lenvatinib in advanced well-differentiated neuroendocrine tumors
Summary
The purpose of this study is to: - Assess overall radiographic response rate (ORR) which is the portion of patients with a tumor size reduction of a predefined amount for a minimum time period - Assess progression-free survival (PFS) - Test the safety and tolerability of pembrolizumab in combination with lenvatinib
Objective
Objective: To assess the overall radiographic response rate (ORR) associated with pembrolizumab in patients with advanced, progressive high-grade and/or poorly differentiated extrapulmonary neuroendocrine cancers. Objective: To assess progression-free survival (PFS) in this population based on RECIST 1.1 and irRECIST. Objective: To assess duration of response (DOR) by RECIST 1.1. Objective: To assess overall survival (OS) in this population. Objective: To assess safety and tolerability.
Therapies
Medications
E7080 (Lenvatinib); Lenvatinib (Lenvima); Pembrolizumab (Keytruda)
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