Randomized, Open-Label Phase II Study Evaluating the Efficacy and Safety of Talimogene Laherparepvec in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced, Unresectable Melanoma
Randomized, Open-Label Phase II Study Evaluating the Efficacy and Safety of Talimogene Laherparepvec in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced, Unresectable Melanoma
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DOI：
10.1200/jco.2017.73.7379
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发表时间：
2018-06-10
影响因子：
45.3
通讯作者：
Kaufman, Howard L.
中科院分区：
文献类型：
--
作者：
Chesney, Jason;Puzanov, Igor;Kaufman, Howard L.
目的：我们在一项II期研究中评估了拉他莫基联合伊匹单抗与单用伊匹单抗治疗晚期黑色素瘤患者的疗效。据我们所知，这是第一个评估将溶瘤病毒添加到检查点抑制剂的随机试验。1例接受Talimogene Laherparepvec加伊匹单抗或单独伊匹单抗。Laherparepvec治疗在第1周开始（第一次剂量，
PurposeWe evaluated the combination of talimogene laherparepvec plus ipilimumab versus ipilimumab alone in patients with advanced melanoma in a phase II study. To our knowledge, this was the first randomized trial to evaluate addition of an oncolytic virus to a checkpoint inhibitor.MethodsPatients with unresectable stages IIIB to IV melanoma, with no more than one prior therapy if BRAF wild-type, no more than two prior therapies if BRAF mutant, measurable/injectable disease, and without symptomatic autoimmunity or clinically significant immunosuppression were randomly assigned 1:1 to receive talimogene laherparepvec plus ipilimumab or ipilimumab alone. Talimogene laherparepvec treatment began in week 1 (first dose,