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HEALTH PROFESSIONAL · SOURCE READING

Nivolumab

Source: Gastric Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: February 21, 2025 · Captured 2026-09-09.

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Context: Treatment of Stage IV, Inoperable, and Recurrent Gastric Cancer / Treatment Options for Stage IV, Inoperable, and Recurrent Gastric Cancer / Third-line palliative systemic therapy / Immunotherapy

Nivolumab has been approved by the Japanese Ministry of Health, Labor, and Welfare for treatment of advanced gastric cancer, regardless of PD-L1 CPS status.

Evidence (nivolumab):

A randomized, double-blinded, placebo-controlled, phase III trial (ONO-4538-12 [ATTRACTION-2] [NCT02267343]) enrolled 493 patients with refractory gastroesophageal/gastric cancer from Japan, South Korea, and Taiwan.[38] Patients were randomly assigned 2:1 to receive either nivolumab (3 mg/kg every 2 weeks) or placebo.

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A randomized, double-blinded, placebo-controlled, phase III trial (ONO-4538-12 [ATTRACTION-2] [NCT02267343]) enrolled 493 patients with refractory gastroesophageal/gastric cancer from Japan, South Korea, and Taiwan.[38] Patients were randomly assigned 2:1 to receive either nivolumab (3 mg/kg every 2 weeks) or placebo.

The median OS was 5.26 months (95% CI, 4.60–6.37) in the nivolumab group compared with 4.14 months (95% CI, 3.42–4.86) in the placebo group.

A randomized, double-blinded, placebo-controlled, phase III trial (ONO-4538-12 [ATTRACTION-2] [NCT02267343]) enrolled 493 patients with refractory gastroesophageal/gastric cancer from Japan, South Korea, and Taiwan.[38] Patients were randomly assigned 2:1 to receive either nivolumab (3 mg/kg every 2 weeks) or placebo.

Serious treatment-related adverse events occurred in 10% of the patients.[38][Level of evidence A1]

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Studies cited in this source section

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Preserved source evidence · Not medical advice