Study
| Single-arm phase II study [NO LIMIT, WJOG13320G]. |
| Microsatellite instability-high advanced gastric or esophagogastric junction cancer. |
| Nivolumab (240 mg every 2 weeks) plus low-dose ipilimumab (1 mg/kg every 6 weeks), n=29. |
Efficacy
| ORR: 62.1% [42.3-79.3], CR: 10.3% |
| mPFS: 13.8 mos [13.7-NR] |
| mOS: NR [13.7-NR], 12-month OS rate: 79.5% [56.8-91.1] |
Safety
| Grade >=3 AEs: 37.9% |
| Hypopituitarism (6.9%), maculopapular rash (6.9%), pneumonitis, thrombocytopenia, lymphocytopenia, diarrhea, gastritis, decreased appetite, hypoalbuminemia, rhabdomyolysis (3.4% each) |
| TRAEs led to discontinuation in 41.4% of patients. |
J Clin Oncol 2025;43:2184-2195
http://doi.org/10.1200/JCO-24-02463
Reviewed by Elvin Chalabiyev, MD on Sep 3, 2025
