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Multicenter Phase 3 Trial Comparing Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma - NADINA
Bristol-Myers Squibb (BMS)
Other Non-Commercial Sponsor
Netherlands Cancer Institute
Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive 2 cycles of neoadjuvant ipilimumab (80mg) and nivolumab (240mg) every 3 weeks, followed by a total lymph node dissection (TLND), and if applicable, surgical removal of in-transit metastases. Participants with a pathologic partial or non-response will also then receive adjuvant nivolumab (480mg) every 4 weeks for 46 weeks. In the case of BRAF V600E/K mutation-positivity, participants with a pathologic partial or non-response will be treated with adjuvant dabrafenib plus trametinib for 46 weeks. In the Active Comparator Arm, participants will receive a standard upfront TLND, and if applicable, surgical removal of in-transit metastases, followed by 12 cycles of adjuvant nivolumab (480mg) every 4 weeks. All study participants will be treated until melanoma progression to irresectable stage III or stage IV disease, disease recurrence, unacceptable toxicity, participant withdrawal of consent or until the end of study treatment.