Advanced Gastric Cancer: Triple Combination Second-Line Immunotherapy

Phase I/II Multicenter Trial

• August 30, 2019

Phase I/II trial (ESMO GI 2019) evaluates nivolumab plus ramucirumab plus paclitaxel for second-line treatment of advanced unresectable/recurrent gastric and gastroesophageal junction cancer.

Treatment Regimen

4-week cycles:

• Nivolumab 3 mg/kg (Days 1, 15)
• Ramucirumab 8 mg/kg (Days 1, 15)
• Paclitaxel 80 mg/m² (Days 1, 8, 15)

Efficacy Results

6-Month Progression-Free Survival: 46.4% (exceeded target >35%)

Median PFS: 5.1 months

By PD-L1 Expression:

• PD-L1 Negative: 6-mo PFS 48.5%
• PD-L1 Positive: 6-mo PFS 66.7%

Objective Response Rate: 37.2%

Safety Profile

Grade 3+ Adverse Events: 93.0%

Immune-Related AEs (Grade 3+): 32.6%

Treatment-Related Mortality: 1 (thrombocytopenia)

Clinical Note

PD-L1 expression appears predictive of improved response, suggesting potential patient enrichment strategy.

Data Source

Phase I/II study of nivolumab combined with paclitaxel plus ramucirumab as second-line treatment in advanced gastric cancer. ESMO Gastrointestinal Cancers 2019, Abstract #SO-001.

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Figure 1