At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction - A Randomized Phase 2 Trial.
In Brief
A Phase 2 clinical trial evaluating Nivolumab, Ipilimumab, and 2 other interventions for Adenocarcinoma of the Stomach and GastroEsophageal Cancer. Completed, enrolled 262 participants across 27 sites.
Detailed Summary
Patients with Her2 negative, previously untreated metastatic esophagogastric adenocarcinoma will be treated with modified FOLFOX, with modified FOLFOX plus Nivolumab and Ipilimumab or FLOT plus Nivolumab. The groups will be compared for time until progression of the disease (primary endpoint) as well as for response to the treatment, overall survival, safety/tolerability of the treatment and quality of life.
Study Details
Timeline
Interventions
Nivolumab 240mg "Flatdose" i.v. d1 over 30 minutes every 2 weeks
1mg/kg i.v. d1 over 30 minutes every 6 weeks
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
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.