Ipilimumab or FOLFOX in Combination With Nivolumab and Trastuzumab in HER2 Positive EsophagoGastric Adenocarcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Adenocarcinoma Gastric
- Esophageal Cancer
- Gastric Cancer
- Gastroesophageal Cancer
- HER2 Positive Gastric Cancer
- Metastatic Gastric Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Gastric cancer is the fifth most common cancer in the world, and the third leading cause of cancer death in both sexes worldwide. Surgical resection is currently the only curative treatment option for gastric cancer; however, ~50% of patients have metastatic disease at the time of diagnosis and chem...
Gastric cancer is the fifth most common cancer in the world, and the third leading cause of cancer death in both sexes worldwide. Surgical resection is currently the only curative treatment option for gastric cancer; however, ~50% of patients have metastatic disease at the time of diagnosis and chemotherapy is the mainstay of palliation in this setting. Trastuzumab, in combination with chemotherapy, significantly improved survival in patients with overexpression of HER2. In regard of the very limited therapeutic landscape of HER2 positive EGA, compared to breast cancer, further treatment options to relevantly improve the outcome is warranted. The integration of check-point inhibitors (e.g. Nivolumab, Ipilimumab) into the first line setting either within a chemotherapy-free combination arm or within an intensified standard arm of FOLFOX and trastuzumab with nivolumab may be able to improve the current limited survival of median 14 months.
Tracking Information
- NCT #
- NCT03409848
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Alexander Stein, Dr. HOPE - Hämatologisch-onkologische Praxis Eppendorf