Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas

Phase 2 Completed 18 enrolled Hoosier Cancer Research Network EMD Serono · collab University of North Carolina, Chapel Hill · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2019-01-24
Primary completion: 2020-09-11
Completion: 2022-08-30

Publications

Lee MS, Chao J, Mulcahy MF, Kasi PM, Alistar AT, Mukherjee S, Akce M, Moore DT, McRee AJ, Somasundaram A. Phase II study of avelumab and trastuzumab with FOLFOX chemotherapy in previously untreated HER2-amplified metastatic gastroesophageal adenocarcinoma. Oncologist. 2025 Jul 4;30(7):oyaf195. doi: 10.1093/oncolo/oyaf195.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avelumab	Monoclonal antibody	800 mg	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	Trastuzumab	Monoclonal antibody	4 mg/kg	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas

Summary

Timeline

Publications

Drugs

Indications