CA209-649: Nivo/Ipi vs SOC in gastric cancer patients
Research type
Research Study
Full title
A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab versus Oxaliplatin plus Fluoropyrimidine in Subjects with Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
IRAS ID
212194
Contact name
Ian Chau
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2016-001018-76
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 15 days
Research summary
This is a phase 3 study of Nivolumab plus Ipilimumab combination treatment compared to the current standard of care of oxaliplatin plus fluoropyrimidine, in patients with previously untreated advanced or metastatic gastroesophageal junction or gastric cancer. The aim of this study is to determine if the combination treatment will improve overall survival of these patients compared to current standard of care chemotherapy.
Globally, approximately 750 patients will be randomised to receive either Nivolumab plus Ipilimumab combination treatment, or either one of the current standard of care treatment options, Xelox or Folfox, as determined by the study doctor, with around 16 patients in the UK. The study is sponsored by Bristol-Myers Squibb (BMS).
Following a screening period, the Nivolumab plus Ipilimumab combination treatment will be administered every 3 weeks for 4 doses followed by Nivolumab monotherapy administered every 2 weeks, until the end of treatment. Administration of the standard of care chemotherapy will be every 2 weeks or every 3 weeks depending on whether the patient receives Folfox or Xelox, respectively. All patients will receive treatment until the disease worsens or an unacceptable toxicity. After the treatment phase, patients will be followed for survival, over the phone or through hospital visits.
Patients will undergo CT scans, physical exams, vital signs such as blood pressure, height, weight, body temperature, blood samples for routine safety testing and study specific testing. Patients will also be required to complete questionnaires regularly throughout the study. A fresh tumour biopsy or archival tumour biopsy is required.
REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/2043
Date of REC Opinion
6 Jan 2017
REC opinion
Further Information Favourable Opinion