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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

197

Participants

Timeline

Start Date

July 17, 2019

Primary Completion Date

December 12, 2023

Study Completion Date

June 30, 2026

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).

Trial Locations (28)

Unknown

Masaryk Memorial Cancer Institute, Brno

University Hospital Hradec Kralove, Hradec Králové

CHRU de Lille - Hopital Huriez, Lille

Hôpital Privé Jean Mermoz, Lyon

Gustave Roussy, Villejuif

Charite - Universitaetsmedizin Berlin, Berlin

Kliniken Essen-Mitte, Essen

Universitaetsklinikum Freiburg, Freiburg im Breisgau

Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center, Hamburg

SLK-Kliniken Heilbronn, Heilbronn

Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden, Leipzig

Klinikum Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar, München

Universitaetsklinikum Tuebingen-Uni Kliniken Berg, Tübingen

Rambam Health Care Campus, Oncology Institute, Haifa

Rabbin Medical Centre - Tel Aviv, Tel Aviv

Azienda Ospedaliera a Papa Giovanni XXIII, Bergamo

Istituto Europeo di Oncologia, Milan

"Istituto Nazionale Tumori IRCCS Fondazione G. Pascale", Napoli

Oslo University Hospital - Ullevaal Hospital, Oslo

Institut Catalan d'Oncologia - ICO Badalona, Badalona

Hospital Universitario 12 de Octubre, Madrid

Complejo Hospitalario A, Pamplona

Hospital Clinico Universitario de Valencia, Valencia

Cambridge University Hospital NHS, Cambridge

Royal Marsden Hospital, London

University College London Hospitals NHS Foundation Trust, London

Royal Marsden Hospital, Sutton

02 781

Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw

All Listed Sponsors
lead

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

NCT03443856 - Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence | Biotech Hunter | Biotech Hunter