NADINA trial: neoadjuvant ipilimumab + nivolumab vs. adjuvant nivolumab in stage III melanoma

Minke W. Lucas, MD, from the Netherlands Cancer Institute, Amsterdam, discusses the rationale of the NADINA trial (NCT04949113), a Phase III randomized study assessing neoadjuvant ipilimumab plus nivolumab for resectable, macroscopic stage III melanoma. This trial builds on prior Phase I and II studies, such as the Phase II OpACIN-neo (NCT02977052) and PRADO (NCT02977052) trials, which demonstrated the safety and effectiveness of the combination. Preclinical and Phase I data suggested that neoadjuvant immune checkpoint blockade was superior to adjuvant use. The trial employs a personalized, response-driven adjuvant strategy based on pathological responses, offering a targeted approach to improve patient outcomes. At the first interim analysis, with a median follow-up of 10 months, the NADINA trial showed a significant improvement in event-free survival (EFS) with neoadjuvant ipilimumab plus nivolumab compared to adjuvant nivolumab. The updated EFS and distant metastasis-free survival (DMFS) were reported at ESMO 2024. This interview took place at the European Society for Medical Oncology (ESMO) 2024 Congress in Barcelona, Spain.

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