A randomized phase 2 study of ipilimumab, nivolumab, and brentuximab vedotin in patients with relapsed Hodgkin lymphoma.

A total of 147 patients aged ≥12 years were randomized between BV/Nivo and BV/Ipi/Nivo; 132 patients were included in the primary efficacy analysis.

共有147名年龄≥12岁的患者在BV/Nivo和BV/Ipi/Nivo之间进行了随机分组；132名患者被纳入主要疗效分析。

The complete response (CR) rate, was 64.7% (52.2, 75.9) for BV/Nivo and 70.3% (57.6, 81.1) for BV/Ipi/Nivo (1-sided P = .29).

完全缓解（CR）率，BV/Nivo组为64.7%（52.2，75.9），而BV/Ipi/Nivo组为70.3%（57.6，81.1）（单侧P = .29）。

The median survival follow-up was 38.0 months (interquartile range, 32.6-48.1).

中位生存随访时间为38.0个月（四分位数范围，32.6-48.1）。

Progression-free survival(PFS) did not significantly differ between the 2 arms (hazard ratio[HR], 0.78, confidence interval[CI], 0.39-1.57; 1-sided P = .24).

无进展生存期（PFS）在两组之间没有显著差异（风险比[HR]，0.78，置信区间[CI]，0.39-1.57；单侧P = .24）。

Treatment-related grade 3+ toxicities in the adult cohort, excluding rash, were similar between both arms (38.5% BV/Nivo and 39.3% BV/Ipi/Nivo); there was a higher frequency of grade 3 rash with BV/Ipi/Nivo (24.6%) compared with BV/Nivo (9.2%).

在成人队列中，排除皮疹外，两组治疗相关的3级及以上毒性反应相似（BV/Nivo组为38.5%，BV/Ipi/Nivo组为39.3%）；与BV/Nivo组的9.2%相比，BV/Ipi/Nivo组的3级皮疹发生频率更高（24.6%）。

We compared PFS by stem cell transplantation (SCT) status in a planned before hoc comparison; 58 patients received SCT, and 36-month PFS (from SCT) was >90% for both arms.

我们计划性地进行了造血干细胞移植（SCT）状态的无进展生存期（PFS）比较；58名患者接受了SCT，两组的36个月PFS（从SCT起算）均>90%。

Sixty-six patients were progression free after the first scan and did not undergo SCT.

首次扫描后，66名患者无进展，并且没有接受SCT。

The 36-month PFS was 73.0% (54.5, 85.0) for BV/Ipi/Nivo compared with 45.8% (26.3, 63.4) for BV/Nivo (HR, 0.45; CI, 0.19-1.08; 1-sided P = .03).

36个月无进展生存期（PFS）对于BV/Ipi/Nivo组为73.0%（54.5，85.0），而BV/Nivo组为45.8%（26.3，63.4）（风险比HR，0.45；置信区间CI，0.19-1.08；单侧P = .03）。

The study did not meet its primary end point of superior CR rate for the triplet, but it supports the use of checkpoint antibody-drug conjugate induction prior to auto SCT, and there is an intriguing signal of disease control for patients wishing to defer or avoid SCT with the triplet of BV/Ipi/Nivo.

该研究未达到三联疗法优越的完全缓解（CR）率的主要终点，但支持在自体干细胞移植（auto SCT）前使用检查点抗体药物偶联物进行诱导治疗，并且对于希望推迟或避免进行SCT的患者，BV/Ipi/Nivo三联疗法显示出疾病控制的有趣信号。

This trial was registered at www.clinicaltrials.gov as NCT01896999.

该试验已在www.clinicaltrials.gov上注册，注册号为NCT01896999。