Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas
Status:
Active, not recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
The initial intent of the study was to be a multi-center single-arm open-label Simon's
two-stage Phase II clinical trial of first-line mFOLFOX6 + trastuzumab + avelumab in
metastatic HER2-amplified gastric and esophageal adenocarcinomas.
Accrual will halt after completion of Stage I (enrollment of 18 patients). This decision is
not due to safety issues. Subjects currently on treatment will continue until criteria as
defined in the protocol is met.
Phase:
Phase 2
Details
Lead Sponsor:
Autumn McRee, MD Michael Sangmin Lee
Collaborators:
EMD Serono University of North Carolina, Chapel Hill