Phase 3
N=2,031
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
Gastric Cancer · Gastroesophageal Junction Cancer · Esophageal Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02872116 ↗Enrolled (actual)
2,031
Serious AEs
65.8%
Results posted
Jun 2022
Primary outcome: Primary: Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 — 14.39; 11.10 Months — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab (Drug); Ipilimumab (Drug); Oxaliplatin (Drug); Capecitabine (Drug); Leucovorin (Drug); Fluorouracil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 |
14.39; 11.10 | <0.0001 sig |
| PRIMARY Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5 |
7.69; 6.05 | <0.0001 sig |
| SECONDARY OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy |
13.73; 11.63; 13.80; 11.37; 14.39; 11.14 | — |
| SECONDARY PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy |
7.75; 6.93; 7.52; 6.93; 8.31; 6.14 | — |
| SECONDARY Objective Response Rate in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy |
48.8; 38.0; 50.1; 38.2; 48.8; 37.7 | — |
| SECONDARY Time to Symptom Deterioration (TTSD) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy |
NA; 21.03 | — |
| SECONDARY OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy |
11.83; 11.73; 11.47; 11.73; 11.63; 11.24 | — |
| SECONDARY PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy |
7.06; 2.83; 6.93; 2.79; 6.28; 2.83 | — |
| SECONDARY Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy |
37.3; 21.7; 37.7; 23.1; 35.9; 24.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or Female at least 18 years of age
- Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
- Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
- Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
- Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study
Exclusion Criteria
- Presence of tumor cells in the brain or spinal cord that have not been treated
- Active known or suspected autoimmune disease
- Any serious or uncontrolled medical disorder or active infection
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Any positive test result for hepatitis B or C indicating acute or chronic infection
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02872116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.