Multicenter phase 3 trial comparing NeoADjuvant Ipilimumab + Nivolumab versus standard Adjuvant nivolumab in macroscopic stage III melanoma – NADINA

Stage III melanoma

EFS, defined as time from randomization to melanoma progression (irresectable stage III or stage IV disease), melanoma recurrence, treatment-related death, or melanoma-related death, whichever occurs first.

OS, defined as time between date of randomization and date of death from any cause;, RFS, defined as time between date of surgery and date of melanoma recurrence, treatment-related death or melanoma-related death, whichever occurs first;, DMFS, defined as time between date of randomization and date of first distant metastasis, treatment-related death or melanoma-related death, whichever occurs first;, EFS including new primary melanoma, defined as time from randomization to a new primary melanoma (excluding melanoma in situ), melanoma progression (irresectable stage III or stage IV disease), melanoma recurrence, treatment-related death, or melanoma-related death, whichever occurs first;, Pathologic response rate (categorized into pCR, near-pCR, MPR, pPR, pNR, according to INMC criteria70, see 7.1.1) in the neoadjuvant arm;, Correlation of pathologic response in the neoadjuvant arm to RFS, DMFS, and OS;, Frequency and duration of all grade and grade 3-5 treatment-related adverse events according to CTCAE 5.0;, Surgical complication rates according to Clavien-Dindo surgical classification;, Quality of life as measured by EORTC QLQ C30, the Melanoma Subscale and Melanoma Surgery Subscale of FACT-M, the Cancer Worry Scale, HADS questionnaire, EQ-5D-5L, the immunotherapy-specific questionnaire, an assessment of work performance, sexual health, and Amsterdam Cognition Scan;, Performing health technology assessments comparing the neoadjuvant arm with the standard adjuvant arm.

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