Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Gastric Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

November 7, 2018

Primary Completion Date

July 19, 2024

Study Completion Date

July 19, 2024

Conditions
Adenocarcinoma of the StomachGastroEsophageal Cancer
Interventions
DRUG

Nivolumab

"Nivolumab 240mg Flatdose i.v. d1 over 30 minutes every 2 weeks"

DRUG

Ipilimumab

1mg/kg i.v. d1 over 30 minutes every 6 weeks

DRUG

mFOLFOX

Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin at a dose of 400 mg/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg/m² iv bolus (day 1), and Fluorouracil at a dose of 2400 mg/m² iv continuous infusion over 44 hours (day 1+2) every 2 weeks

DRUG

FLOT

"Docetaxel at a dose of 50 mg/m² iv over one hour (day 1), Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin\* at a dose of 200 mg/m² iv over one hour (day 1), Fluorouracil at a dose of 2600 mg/m² iv over 24 hours (day 1) every 2 weeks~\* Note: Leucovorin can be replaced by sodium folinate that is given according to local guideline."

Trial Locations (27)

60488

Krankenhaus Nordwest, Frankfurt

Unknown

Klinikum St. Marien Amberg, Amberg

Klinikum Aschaffenburg, Aschaffenburg

HELIOS Klinikum Bad Saarow, Bad Saarow

Charité CVK, Berlin

HELIOS Klinikum Berlin Buch, Berlin

Klinikum Bielefeld, Bielefeld

Städtisches Klinikum Dresden, Dresden

Universitätsklinikum TU Dresden, Dresden

Agaplesion Markus KH Frankfurt, Frankfurt am Main

Frankfurt Universitätsklinikum, Frankfurt am Main

Hamburg Onkologische Schwerpunktpraxis Eppendorf, Hamburg

Hämatologisch-Onkologische Praxis Altona (HOPA), Hamburg

Universitätsklinikum Jena, Jena

Ortenau Klinikum Lahr, Lahr

Klinikum Ludwigsburg, Ludwigsburg

Universitätsklinikum Lübeck, Lübeck

Universitätsmedizin Mannheim, Mannheim

Universitätsklinikum Marburg, Marburg

Klinikum der Universität München Großhadern, München

Klinikum r.d. Isar, München

Studienzentrum Onkologie Ravensburg, Ravensburg

Universitätsklinikum Tübingen, Tübingen

Universitätsklinikum Ulm, Ulm

Klinikum Weiden, Weiden

Helios Dr. Horst Schmidt Kliniken, Wiesbaden

Klinikum Wolfsburg, Wolfsburg

All Listed Sponsors
lead

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER

NCT03647969 - Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Gastric Cancer | Biotech Hunter | Biotech Hunter