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A Single Arm, Multi-center Phase 2 Trial of mFOLFOX6 + Trastuzumab + Avelumab in First-line, Metastatic, HER2-amplified Gastric and Esophageal Adenocarcinomas

Status
Active
Cancer Type
Colon/Rectal Cancer
Head and Neck Cancer
Stomach/ Gastric Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Female
Study Type
Treatment
NCD ID
NCT03783936
Protocol IDs
HCRN GI17-319 (primary)
NCI-2018-03813
Study Sponsor
Michael Sangmin Lee

Summary

This study will be a prospective, open-label, single arm, multi-center phase 2 clinical trial of mFOLFOX6 + trastuzumab + avelumab in first-line, metastatic, HER2-amplified gastric and esophageal adenocarcinomas. The primary objective of this study is to estimate the best objective response rate (CR or PR, ORR) in these patients within 24 weeks by RECIST 1.1 criteria. Secondary objectives include; estimating PFS by both RECIST 1.1 and iRECIST criteria, estimating OS, estimating the disease control rate (DCR) at 24 weeks by RECIST 1.1 and iRECIST, and characterizing the safety issues associated with this regimen.
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