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

Conditions

• Gastric and Esophagogastric Junction Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab and Ipilimumab — DRUG
  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
• chemotherapy — OTHER
  Completion of the perioperative treatment according to the 2016 ESMO guidelines (change of regimen is not allowed).

Study Details

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

Key Dates

Start date

Jul 17, 2019

Status verified

Jan 2024

Primary completion

Dec 12, 2023

Completion

Jun 30, 2026

Study Design

Enrollment

197 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: chemotherapy arm
  Completion of the perioperative treatment according to the 2016 ESMO guidelines (change of regimen is not allowed).
• Experimental: immunotherapy arm
  Treatment: 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. No chemotherapy.

Primary Outcome Measure

Disease free survival (DFS) [ Time Frame: 22 months after last patient in ]