NADINA
Neoadjuvant nivolumab and ipilimumab versus surgery followed by adjuvant nivolumab in resectable, macroscopic stage III melanoma
Phase 3N = 423NCT04949113
- Population
- Patients with resectable, macroscopic stage III melanoma
- Design
- Randomised phase 3 trial. Neoadjuvant group: two cycles of ipilimumab plus nivolumab, surgery, and adjuvant treatment only for patients with a partial response or nonresponse. Adjuvant group: surgery followed by 12 cycles of adjuvant nivolumab. Primary endpoint event-free survival.
- Primary endpoint
- EFS
- Arms
- Neoadjuvant ipilimumab plus nivolumab (experimental): Two cycles of neoadjuvant ipilimumab plus nivolumab, surgery, then response-driven adjuvant therapy (partial response or nonresponse only)
- Adjuvant nivolumab (control): Surgery followed by 12 cycles of adjuvant nivolumab
- People
- Blank CU, senior author Long GV
EFSHR 0.32Δ 12-month EFS+26.5 points
Show the numbers
| Endpoint | Analysis | Neoadjuvant ipilimumab plus nivolumab | Adjuvant nivolumab | Effect |
|---|---|---|---|---|
| EFSAll randomised patients (the abstract does not name the analysis population) | primarymedian follow-up 9.9 monthsBlank 2024 | 83.7% at 12 mo | 57.2% at 12 mo | HR 0.32P<0.001Estimated 12-month event-free survival with 99.9% confidence intervals of 73.8 to 94.8 (neoadjuvant) and 45.1 to 72.7 (adjuvant). Hazard ratio for progression, recurrence, or death 0.32 with a 99.9% confidence interval of 0.15 to 0.66. Difference in restricted mean survival time 8.00 months (99.9% CI 4.94 to 11.05; P<0.001; the abstract attaches this P value to the restricted-mean-survival-time difference, not separately to the hazard ratio). Grade 3 or higher treatment-related adverse events 29.7% (neoadjuvant) vs 14.7% (adjuvant). The abstract does not state the analysis population or the event definition. |
| MPRNeoadjuvant group | exploratoryBlank 2024 | 59% | — | Single-arm descriptive result within the neoadjuvant group: major pathological response 59.0%, partial response 8.0%, nonresponse (more than 50% residual viable tumour) 26.4%, progression 2.4%; surgery not yet performed or omitted in 4.2%. Estimated 12-month recurrence-free survival 95.1% (major pathological response), 76.1% (partial response), 57.0% (nonresponse); these are response-defined subgroups, not randomised comparisons. |
| Endpoint | Analysis | Neoadjuvant ipilimumab plus nivolumab | Adjuvant nivolumab | Effect |
|---|---|---|---|---|
| EFSAll randomised patients (the abstract does not name the analysis population) | primarymedian follow-up 9.9 monthsBlank 2024 | 83.7% at 12 mo | 57.2% at 12 mo | HR 0.32P<0.001Estimated 12-month event-free survival with 99.9% confidence intervals of 73.8 to 94.8 (neoadjuvant) and 45.1 to 72.7 (adjuvant). Hazard ratio for progression, recurrence, or death 0.32 with a 99.9% confidence interval of 0.15 to 0.66. Difference in restricted mean survival time 8.00 months (99.9% CI 4.94 to 11.05; P<0.001; the abstract attaches this P value to the restricted-mean-survival-time difference, not separately to the hazard ratio). Grade 3 or higher treatment-related adverse events 29.7% (neoadjuvant) vs 14.7% (adjuvant). The abstract does not state the analysis population or the event definition. |
| MPRNeoadjuvant group | exploratoryBlank 2024 | 59% | — | Single-arm descriptive result within the neoadjuvant group: major pathological response 59.0%, partial response 8.0%, nonresponse (more than 50% residual viable tumour) 26.4%, progression 2.4%; surgery not yet performed or omitted in 4.2%. Estimated 12-month recurrence-free survival 95.1% (major pathological response), 76.1% (partial response), 57.0% (nonresponse); these are response-defined subgroups, not randomised comparisons. |