Phase 2
Completed N=114
An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy
Source: ClinicalTrials.gov NCT01585987 ↗Enrolled (actual)
114
Serious AEs
47.2%
Results posted
Nov 2015
Primary outcomePrimary: Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines — 2.9240; 4.8950 Months — p=0.0972
Summary
The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines |
2.9240; 4.8950 | 0.0972 |
| SECONDARY Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria |
2.7270; 4.8950 | 0.0336 sig |
| SECONDARY Overall Survival (OS) at Primary Endpoint |
16.7560; 12.0570 | 0.6433 |
| SECONDARY Overall Survival (OS) at Study Completion |
12.68; 12.06 | — |
| SECONDARY Percentage of Participants With Immune-Related Best Overall Response (irBOR) |
1.8; 7.0 | 0.3686 |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Key Inclusion Criteria
- Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction
- Received first-line chemotherapy using fluoropyrimidine and platinum combination without disease progression
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable disease by modified WHO criteria (unless complete response from previous chemotherapy)
Key Exclusion Criteria
- Known Human Epidermal growth factor Receptor2 (HER2) positive status
- Radiological evidence of brain metastases
- History of severe autoimmune or immune mediated disease requiring prolonged immunosuppressive treatment
- Inadequate hematologic, renal and hepatic function
Data sourced from ClinicalTrials.gov (NCT01585987). 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. Informational only — not medical advice.