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To test the efficacy and safety of combining a novel vaccine (TriMixDC-MEL) with the anti-CTLA-4 antibody ipilimumab for melanoma, investigators in Europe conducted an open-label, single-arm, single-center, phase II trial involving 39 pretreated patients with advanced disease.
TriMixDC-MEL was administered intradermally and intravenously on the same dates as ipilimumab intravenous administration (10 mg/kg every 3 weeks for 4 cycles and then every 12 weeks as maintenance until progression or unacceptable toxicity).
Adverse events were as expected with ipilimumab, and the added toxicity from the vaccine was minimal. The study met its primary endpoint, as slightly more than half of patients (51%) achieved disease control at 6 months. Overall, 15…