NCT03783936

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Ashwin Somasundaram · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Adenocarcinoma
• Esophageal Adenocarcinoma
• Metastasis
• HER-2 Gene Amplification

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Oxaliplatin 85 mg/m2
DRUG	Leucovorin	Leucovorin 400 mg/m2
DRUG	5 fluorouracil	5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion
DRUG	Trastuzumab	Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1
DRUG	Avelumab	Avelumab 800 mg

Timeline

• Start date: 2019-01-24
• Primary completion: 2020-09-11
• Completion: 2022-08-30
• First posted: 2018-12-21
• Last updated: 2023-12-19
• Results posted: 2023-12-19

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study