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Ipilimumab or FOLFOX in Combination With Nivolumab and Trastuzumab in HER2 Positive EsophagoGastric Adenocarcinoma

NCT03409848 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2022-05-18

No results posted yet for this study

Summary

The INTEGA study assesses therapy Options for advanced or metastatic esophagogastric Adenocarcinoma in patients overexpressing human epidermal receptor type 2 (HER2 positive patients). Current treatment options in this situation include chemotherapy based palliative treatment in combination withTrastuzumab.

Recent studies have shown that immunotherapy with Nivolumab or Ipilimumab after previous chemotherapy can also improve survival in esophagogastric cancer.

This study assesses the efficacy of two experimental first line treatment strategies: A) Chemo-free immunotherapy with Trastuzumab, Nivolumab and Ipilimumab and B) addition of Nivolumab to the standard regimen (FOLFOX chemotherapy and Trastuzumab).

Conditions

Interventions

DRUG

Nivolumab

Addition of Nivolumab to Standard therapy (chemotherapy and Trastuzumab)

DRUG

Nivolumab

Chemo-free immunotherapy with Nivolumab, Ipilimumab, Trastuzumab

DRUG

Ipilimumab

Chemo-free immunotherapy with Nivolumab, Ipilimumab, Trastuzumab

Sponsors & Collaborators

Principal Investigators

  • Alexander Stein, Dr. · HOPE - Hämatologisch-onkologische Praxis Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2022-03-05
Completion
2022-03-05

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03409848 on ClinicalTrials.gov