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

NCT03443856 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2024-01-05

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Florian Lordick · Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden, Leipzig, Germany

  • Maren Knoedler · Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden, Leipzig, Germany

  • Elizabeth Smyth · Cambridge University Hospital NHS - Cambridge, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2023-12-12
Completion
2026-06-30
FDA Drug
Yes

Countries

  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Norway
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03443856 on ClinicalTrials.gov