NCT04006262

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

Peri-operative Association of Immunotherapy (Pre-operative Association of Nivolumab and Ipilimumab, Post-operative Nivolumab Alone) in Localized Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR) Oeso-gastric Adenocarcinoma: An Open-label GERCOR Phase II Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In patients with resectable oeso-gastric adenocarcinoma, radical surgery is the only curative option. Despite the evolution in treatment with multimodality treatment strategies, oeso-gastric cancer remains one of the most lethal malignancies with 5-year survival rates reaching only 22%. When the disease is localized, perioperative chemotherapy with cytotoxic agents is the preferred strategy since it increases the overall survival (OS) rate. However, in oeso-gastric cancers with microsatellite instability (MSI), is a favorable prognostic factor, the recommended cytotoxic chemotherapy combination seems inefficient and even deleterious. It is now well established that dMMR and or the MSI phenotype are the surrogate markers of response to immunotherapy. The combination of nivolumab and ipilimumab had shown promising efficacy in multiple tumor types (dMMR/MSI). Based on the data above, we have designed this phase II study to evaluate the complete pathological response rate (cPRR) in patients with non-metastatic MSI/dMMR oeso-gastric adenocarcinoma treated with neoadjuvant nivolumab and ipilimumab treatment.

Conditions

• Localized Oesogastric Adenocarcimona
• MSI and or dMMR

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-10-23
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2019-07-05
• Last updated: 2025-06-15

Locations

15 sites across 1 country: France