Practice-entering research
NADINA — neoadjuvant ipi+nivo vs adjuvant nivo in stage III melanoma
Multicenter Phase 3 Trial Comparing Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma — NADINA
- Phase
- Phase III
- Recruitment
- Active, not recruiting
- Results maturity
- Primary analysis
- Publication
- Peer-reviewed
- Regulatory approval
- No regulatory approval
- NCT
- NCT04949113
- Registry checked
- 2026-10-29
- Editorial update
- 2026-10-29
Not a treatment recommendation. Experimental or ongoing research does not by itself replace standard care.
For patients
What is being studied? Immunotherapy before surgery for stage III melanoma may improve disease control versus immunotherapy after surgery. Side effects may increase.
Why promising? Phase III: neoadjuvant combination IO prolonged EFS versus adjuvant nivolumab.
What is not proven? All melanoma stages; net benefit without toxicity; identical protocol in every center.
Is this standard care today? This listing alone does not replace standard care; approval and guideline context require clinician judgment.
For clinicians
n=423; 12-mo EFS 83.7% vs 57.2%; HR 0.32. Grade ≥3 treatment-related AE 29.7% vs 14.7%.
Cancer / population: Melanoma — Rezeke edilebilir makroskopik evre III melanom
Intervention: 2 siklus neoadjuvan ipi+nivo → cerrahi (± yanıt güdümlü adjuvan)
Primary endpoint: Olay-sız sağkalım (EFS)
Source-verified summary: 12-mo EFS 83.7% vs 57.2%; HR 0.32 (99.9% CI 0.15–0.66).
Limitations: Erken izlem medyanı (~10 ay) ilk raporda; uzun dönem güncelleme izlenmeli.
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