An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy

Phase 2 Completed 143 enrolled Bristol-Myers Squibb

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2012-07
Primary completion: 2014-07
Completion: 2015-04

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Ipilimumab vs All Best Supportive Care (BSC); p = 0.0972; NCT01585987 ↗

registry MEDIAN Ipilimumab: 2.9240 (1.6100 to 5.1580) Months MEDIAN All Best Supportive Care (BSC): 4.8950 (3.4500 to 6.5380) Months NCT01585987 ↗

Publications

Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	10 mg/kg	Intravenous