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. 2021 Jun 1;44(6):254-257.
doi: 10.1097/COC.0000000000000820.

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

Maria Constantinou  1 , Thomas J Miner, John M Vatkevitch, Ali Naboush, Sopha Dionson, Jasmine Anderson, Taylor Kolvek, Maria Medeiros, Kelsey MacKinnon, Roxanne Wood, Howard Safran
Affiliations

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

Maria Constantinou et al. Am J Clin Oncol. .

Abstract

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.

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Conflict of interest statement

The authors declare no conflicts of interest.

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