Pre-operative Nivolumab and Ipilimumab, Followed by Post-operative Nivolumab, for MSI/dMMR Oeso-gastric Adenocarcinoma.
- Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Study ID
- NCT04006262
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Localized Oesogastric Adenocarcimona
- MSI and or dMMR
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab 10 MG/ML — DRUGNeo-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
- Ipilimumab 200 MG in 40 ML Injection — DRUGNeo-adjuvant treatment : 1mg/kg over 30 minutes every 6 cycles - 2 cycles
Study Details
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.
Key Dates
- Start date
- Oct 23, 2019
- Status verified
- Jun 2025
- Primary completion
- Oct 31, 2025
- Completion
- Oct 31, 2025
Study Design
- Enrollment
- 32 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental arm* Neo-adjuvant treatment (6 cycles - 12 weeks) * Surgery * Adjuvant treatment (9 cycles - 9 months)
Primary Outcome Measure
Complete pathological response (cPRR) rate [ Time Frame: time point when the tumor is examined after the surgery (up to 30 months) ]