NCT03409848

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

Ipilimumab or FOLFOX in Combination With Nivolumab and Trastuzumab in Previously Untreated HER2 Positive Locally Advanced or Metastatic EsophagoGastric Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 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.

Conditions

• Gastric Cancer
• Esophageal Cancer
• Adenocarcinoma Gastric
• HER2 Positive Gastric Cancer
• Metastatic Gastric Cancer
• GastroEsophageal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-01
• Primary completion: 2022-03-05
• Completion: 2022-03-05
• First posted: 2018-01-24
• Last updated: 2022-05-18

Locations

35 sites across 1 country: Germany