NCT03443856

Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence

Adjuvant Immunotherapy in Patients With Resected Gastric Cancer Following Preoperative Chemotherapy With High Risk for Recurrence (N+ and/or R1): an Open Label Randomized Controlled Phase-2-study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3 and/or R1 status) following neoadjuvant chemotherapy and resection. Other study objectives: * To investigate the safety and effect of adjuvant immunotherapy on long term oncologic outcomes and quality of life of patients in the study * To correlate nutritional status assessment on outcomes and quality of life of patients

Conditions

• Gastric and Esophagogastric Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab and Ipilimumab	Nivolumab 1 mg/kg IV Q3W plus Ipilimumab 3 mg/kg IV Q3W for 4 cycles (3 months) followed by nivolumab 240 mg flat-dose IV Q2W for 9 months.Total treatment time 1 year
OTHER	chemotherapy	Completion of the perioperative treatment according to the 2016 ESMO guidelines (change of regimen is not allowed).

Timeline

• Start date: 2019-07-17
• Primary completion: 2023-12-12
• Completion: 2026-06-01
• First posted: 2018-02-23
• Last updated: 2024-01-05

Locations

28 sites across 9 countries: Czechia, France, Germany, Israel, Italy, Norway, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study