切除 IIB/C 期黑色素瘤的患者复发风险很高，与切除 IIIA/B 期黑色素瘤的患者相似。 3 期双盲 CheckMate 76K 试验对 790 名已切除的 IIB/C 期黑色素瘤患者进行了评估，这些患者按 2:1（按肿瘤类别分层）随机分配至纳武单抗 480mg 或安慰剂组，每 4 周一次，持续 12 个月。主要终点是研究者评估的无复发生存期（RFS）。次要终点包括无远处转移生存期（DMFS）和安全性。在最短随访 7.8 个月时，纳武单抗与安慰剂相比显着改善 RFS（风险比 (HR) = 0.42；95% 置信区间 (CI)：0.30-0.59；P < 0.0001），12 个月 RFS 为 89.0% 79.4% 并在各个亚组中观察到益处； DMFS 也得到改善（HR = 0.47；95% CI：0.30-0.72）。 10.3%（纳武单抗）和 2.3%（安慰剂）的患者发生与治疗相关的 3/4 级不良事件。纳武利尤单抗治疗期间发生了 1 例治疗相关死亡 (0.2%)。对于已切除的 IIB/C 期黑色素瘤患者，纳武单抗是一种有效且普遍耐受性良好的辅助治疗。 ClinicalTrials.gov 标识符：NCT04099251 .© 2023。作者。

Patients with resected stage IIB/C melanoma have high recurrence risk, similar to those with resected stage IIIA/B disease. The phase 3, double-blind CheckMate 76K trial assessed 790 patients with resected stage IIB/C melanoma randomized 2:1 (stratified by tumor category) to nivolumab 480 mg or placebo every 4 weeks for 12 months. The primary endpoint was investigator-assessed recurrence-free survival (RFS). Secondary endpoints included distant metastasis-free survival (DMFS) and safety. At 7.8 months of minimum follow-up, nivolumab significantly improved RFS versus placebo (hazard ratio (HR) = 0.42; 95% confidence interval (CI): 0.30-0.59; P < 0.0001), with 12-month RFS of 89.0% versus 79.4% and benefit observed across subgroups; DMFS was also improved (HR = 0.47; 95% CI: 0.30-0.72). Treatment-related grade 3/4 adverse events occurred in 10.3% (nivolumab) and 2.3% (placebo) of patients. One treatment-related death (0.2%) occurred with nivolumab. Nivolumab is an effective and generally well-tolerated adjuvant treatment in patients with resected stage IIB/C melanoma. ClinicalTrials.gov identifier: NCT04099251 .© 2023. The Author(s).