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IMMUNED Trial: Neoadjuvant Immunotherapy for Stage IV Melanoma With No Evidence of Disease

By: Joseph Fanelli
Posted: Wednesday, November 27, 2019

For patients diagnosed with stage IV melanoma with no evidence of disease, adjuvant therapy with nivolumab alone or in combination with ipilimumab resulted in longer recurrence-free survival than treatment with placebo, according to findings from the phase II IMMUNED trial presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona (Abstract LBA67). Dirk Schadendorf, MD, of the University Hospital Essen, Germany, and colleagues also reported a higher frequency of grade 3 and 4 treatment-related adverse events in this trial compared than in the CheckMate 067 trial of patients with unresectable melanoma.

In this double-blind trial, the investigators enrolled 167 patients across 20 German health centers who had stage IV cutaneous or unknown primary melanoma and had received neoadjuvant surgery or radiation therapy. Patients were administered 3 mg/kg of nivolumab once every 2 weeks (n = 59), 1 mg/kg of nivolumab plus 3 mg/kg of ipilimumab once every 3 weeks for 4 doses followed by 3 mg/kg of nivolumab every 2 weeks (n = 56), or placebo (n = 52). Of the study patients, 162 had received at least one infusion.

At a median follow-up of 28.4 months, patients treated with nivolumab experienced significantly longer recurrence-free survival (hazard ratio = 0.56) than those who received placebo (hazard ratio = 0.23). The results from a prespecified subgroup analysis showed a consistent hazard ratio favoring nivolumab and nivolumab plus ipilimumab over placebo.

Patients treated with nivolumab and ipilimumab reported higher rates of grade 3 and 4 treatment-related adverse events (71%) than those treated with nivolumab alone (27%). Treatment-related adverse events of any grade resulted in treatment discontinuation in 13% of those treated with nivolumab alone, 62% of patients treated with nivolumab and ipilimumab, and 2% of those treated with a placebo. No treatment-related deaths were reported.

Disclosure: For full disclosures of the study authors, visit

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