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Title:
A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination with Oxaliplatin plus Fluoropyrimidine versus Oxaliplatin plus Fluoropyrimdine in Subjects with Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer (CA209-649)
Protocol Number:
J16140
Phase:
Phase III
Physician:
Kristen Marrone
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
To evaluate the safety and tolerability and to compare the overall survival of patients with advanced or metastatic gastric or gastroesophageal junction cancer when treated with the combination of nivolumab plus ipilimumab or nivolumab in combination with oxaliplatin plus a fluoropyrimidine versus oxaliplatin plus a fluoropyrimidine.
Eligibility:
Patients with inoperable advanced or metastatic gastric or gastroesophageal junction cancers confirmed as adenocarcinoma and previously untreated with systemic therapy.Prior adjuvant or neoadjuvant chemotherapy, radiotherapy and/or chemoradiotherapy is allowed if completed at least 6 months prior.Good physical condition with good blood counts and organ function Measurable diseaseTumor tissue available for biomarker analysisHER2 positive disease is not allowedBrain metastases are allowed as long as they have been treated and controlled for at least 2 weeksNo prior treatment with anti-PD-1 or other drug targeting checkpoint pathwaysNo prior malignancy within 3 yearsNo known autoimmune diseaseNo conditions requiring treatment with steroids ( greater than 10 mg daily prednisone) or other immunosuppressive medications within 14 days of study drugPeripheral neuropathy effecting function is not allowedNo serious or uncontrolled medical conditions, active infections, or known HIV, hepatitis B, or hepatitis C positive
Treatment:
Patients will be randomized to one of three treatment arms:Nivolumab-plus-Ipilimumab Arm: Nivolumab administered IV over 30 minutes followed by ipilimumab administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks for 4 doses, followed by nivolumab monotherapy administered IV over 30 minutes every 2 weeks.Nivolumab-plus-Chemotherapy Arm (XELOX or FOLFOX): Nivolumab plus XELOX: Nivolumab administered IV over 30 minutes on Day 1 of each treatment cycle every 3 weeks. XELOX (Oxaliplatin administered IV every 3 weeks + Capecitabine taken orally twice daily for 14 days every 3 weeks) ORNivolumab plus FOLFOX: Nivolumab administered IV over 30 minutes on Day 1 of each treatment cycle every 2 weeks. FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil each administered IV on Day 1 every 2 weeks, and Fluorouracil administered IV as a continuous infusion over 24 hours Days 1-2 every 2 weeks). Chemotherapy Arm (XELOX or FOLFOX): XELOX (Oxaliplatin administered IV every 3 weeks + Capecitabine taken orally twice daily for 14 days every 3 weeks) ORFOLFOX (Oxaliplatin + Leucovorin + Fluorouracil each administered IV on Day 1 every 2 weeks, and Fluorouracil administered IV as a continuous infusion over 24 hours Days 1-2 every 2 weeks).
Population:
Adult
Last Update
03/05/2019 05:03 AM