Acronym:
CA209-649
ACTRN/NCT /ethics:
NCT02872116
Scientific title:
A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Summary of trial and patient characteristics
| Cancer Type | Stomach & Oesophageal | ||
|---|---|---|---|
| Trial Type | Treatment | ||
| Phase | Phase III | Tumour Stream | Gastric Cancer Gastroesophageal Junction Cancer |
| Age Range | 18 years and older | Cancer Stage | Locally Recurrent or Locally Advanced, Metastatic or Widespread |
| Sex | Both | Anticipated Start Date | 2016-10-04 |
| Molecular Target | Anticipated End Date | 2020-10-11 | |
| Cancer Type | Stomach & Oesophageal |
|---|---|
| Trial Type | Treatment |
| Phase | Phase III |
| Age Range | 18 years and older |
| Sex | Both |
| Molecular Target | |
| Tumour Stream | Gastric Cancer Gastroesophageal Junction Cancer |
| Cancer Stage | Locally Recurrent or Locally Advanced, Metastatic or Widespread |
| Anticipated Start Date | 2016-10-04 |
| Anticipated End Date | 2020-10-11 |
Trial Summary
The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.
Lay Summary
A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Sponsor / Cooperative group
Bristol-Myers Squibb
Participating Hospitals
| Hospital | Clinical Trial Coordinator | Phone | Principal Investigator | Recruitment Status | |
|---|---|---|---|---|---|
| Royal Adelaide Hospital | Anne Milton | anne.milton@sa.gov.au | 08 7074 2342 | Nimit Singhal | Recruitment on Hold |