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Pre-operative Nivolumab and Ipilimumab, Followed by Post-operative Nivolumab, for MSI/dMMR Oeso-gastric Adenocarcinoma.

NCT04006262 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-06-15

No results posted yet for this study

Summary

This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate the complete pathologic response rate (cPRR) with neoadjuvant nivolumab and ipilimumab combination in patients with MSI and/or dMMR localized oeso-gastric cancer.

Conditions

  • Localized Oesogastric Adenocarcimona
  • MSI and or dMMR

Interventions

DRUG

Nivolumab 10 MG/ML

Neo-adjuvant treatment : 240 mg intravenous (I.V.) in 30 minutes - every 2 weeks - 6 cycles \- Adjuvant treatment : 480mg I.V. in 30 minutes - every 4 weeks - 9 cycles

DRUG

Ipilimumab 200 MG in 40 ML Injection

Neo-adjuvant treatment : 1mg/kg over 30 minutes every 6 cycles - 2 cycles

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Principal Investigators

  • Thierry ANDRE, MD · Hôpital Saint Antoine PARIS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • France

Study Locations

More Related Trials

Entities

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 NCT04006262 on ClinicalTrials.gov