A Pilot Study of Short-course Nivolumab and Low-dose Ipilimumab for Adjuvant Treatment of Melanoma Brown University Oncology Research Group Trial, BrUOG 324

被引:2
作者
Constantinou, Maria [1 ]
Miner, Thomas J. [1 ]
Vatkevitch, John M. [1 ]
Naboush, Ali [1 ]
Dionson, Sopha [1 ]
Anderson, Jasmine [1 ]
Kolvek, Taylor [1 ]
Medeiros, Maria [1 ]
MacKinnon, Kelsey [1 ]
Wood, Roxanne [1 ]
Safran, Howard [1 ]
机构
[1] Rhode Isl Hosp, Lifespan Canc Inst, Providence, RI 02906 USA
来源
AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS | 2021年 / 44卷 / 06期
关键词
nivolumab; ipilimumab; adjuvant treatment; melanoma; immune checkpoint inhibitors; cutaneous oncology; immunotherapy; PD-1; inhibitors; CTLA-4; STAGE-III; PLUS IPILIMUMAB;
D O I
10.1097/COC.0000000000000820
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: Combined cytotoxic T-lymphocyte-associated antigen 4 and programmed death 1 inhibitor blockade is a promising strategy in advanced melanoma and other solid tumors. This pilot study assessed the safety and toxicity of nivolumab plus low-dose ipilimumab in patients with high-risk completely resected melanoma. Patients and Methods: Patients received ipilimumab, 1 mg/kg every 6 weeks, and nivolumab, 3 mg/kg every 2 weeks, for a total of 24 weeks (4 cycles). The primary objective was to assess the toxicity of the combined regimen. Results: Twenty-one patients with resected melanoma were enrolled. One patient was stage IIC, 16 patients were stage III and 4 patients had resected stage 4 disease. Ten of 21 (48%) had grade 3 treatment-related toxicities but there was no grade 4 or grade 5 toxicities. The rate of grade 3 nonhematologic toxicities exceeded the toxicity limits defined by the study. Fifteen of 21 patients (71%) completed all 4 cycles of therapy. The median follow-up is 41 months. The 2-year recurrence-free survival is 85.7% and the 2-year overall survival is 90.5%. Conclusion: A 6-month course of nivolumab and low-dose ipilimumab may be a promising adjuvant treatment for patients with resected melanoma. Further studies of this regimen are indicated.
引用
收藏
页码:254 / 257
页数:4
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