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

NCT03783936 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-12-19

Study results available
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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

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

Sponsors & Collaborators

  • EMD Serono

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Ashwin Somasundaram

    lead OTHER

Principal Investigators

  • Ashwin Somasundaram, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2020-09-11
Completion
2022-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03783936 on ClinicalTrials.gov