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Dosing Schedule for Neoadjuvant Ipilimumab and Nivolumab in Stage III Melanoma

By: Lauren Harrison, MS
Posted: Tuesday, September 3, 2019

The OpACIN-neo trial successfully identified a dosing schedule for neoadjuvant ipilimumab plus nivolumab, generating a pathologic response in a high proportion of patients with stage III melanoma. Elisa A Rozeman, MD, of the Netherlands Cancer Institute, and colleagues published the results of the phase II trial in The Lancet Oncology.

“When more mature data confirm these early observations, this schedule should be tested in randomized phase III studies vs adjuvant therapies, which are the current standard-of-care systemic therapy for patients with stage III melanoma,” the investigators commented.

From November 2016 through June 2018, patients with resectable stage III melanoma involving lymph nodes alone were enrolled in this study. A total of 86 patients, who were from three sites in Australia, Sweden, and the Netherlands, were randomly assigned 1:1:1 to receive one of three dosing schedules. Group A (30 patients) received 2 cycles of ipilimumab at 3 mg/kg plus nivolumab at 1 mg/kg once every 3 weeks; group B (30 patients) received 2 cycles of ipilimumab at 1 mg/kg plus nivolumab at 3 mg/kg once every 3 weeks; and group C (26 patients) received 2 cycles of ipilimumab at 3 mg/kg once every 3 weeks followed by 2 cycles of nivolumab at 3 mg/kg once every 2 weeks.

A radiologic objective response was found in 63% of patients in group A, 57% of patients in group B, and 35% of patients in group C. In addition, pathologic responses were seen in 80% of patients in group A, 77% of patients in group B, and 65% of patients in group C.

In the first 12 weeks of the study, grade 3 or 4 immune-related adverse events were seen in 40% of patients in group A, 20% of patients in group B, and 50% of patients in group C. Common adverse events included elevated liver enzymes in group A (20%) and colitis in group C (19%). No more than one patient had any of these grade 3 or 4 adverse events in group B.

Disclosure: The study authors’ disclosure information may be found at thelancet.com.



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