# NADINA

Source: https://onco.cc/trials/nadina/  
OnCo record `nadina` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Giving the immunotherapy doublet before surgery, instead of nivolumab after, cut the risk of recurrence by about two thirds and let most patients skip further treatment.

## Summary

Presented at the ASCO 2024 plenary and published in NEJM (June 2024). 12-month EFS 83.7% vs 57.2%; HR for progression, recurrence or death 0.32. Around 59% of the neoadjuvant arm had a major pathological response and received no adjuvant therapy. The first phase 3 in oncology to test an immunotherapy-only neoadjuvant regimen against standard of care; adopted into NCCN and ESMO guidance as a preferred option for resectable nodal disease.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT04949113
- Phase: 3
- Setting: Resectable macroscopic stage III melanoma: two cycles neoadjuvant ipilimumab + nivolumab then surgery (adjuvant only if incomplete response) vs surgery then 12 cycles adjuvant nivolumab
- Sponsor: Netherlands Cancer Institute / Melanoma Institute Australia
- Enrolled: 423
- Result: 12-month EFS 83.7% vs 57.2%; HR 0.32.
- Outcomes: Event-free survival at 12 months: Neoadjuvant ipilimumab + nivolumab 83.7% vs Adjuvant nivolumab 57.2%, HR 0.32
- Replication: SWOG S1801 (neoadjuvant pembrolizumab) independently showed an EFS benefit for the neoadjuvant sequence, with a different drug.

## Sources

- ClinicalTrials.gov NCT04949113: https://clinicaltrials.gov/study/NCT04949113
- NEJM 2024: https://www.nejm.org/doi/full/10.1056/NEJMoa2402604

## Connected records

- cancers: [Acral melanoma](https://onco.cc/cancers/acral-melanoma/), [BRAF V600-mutant melanoma](https://onco.cc/cancers/braf-v600-melanoma/), [Melanoma](https://onco.cc/cancers/melanoma/), [Stage III melanoma (after surgery)](https://onco.cc/cancers/stage-iii-melanoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [CTLA-4](https://onco.cc/targets/ctla4/), [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Ipilimumab](https://onco.cc/drugs/ipilimumab/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- institutions: [Netherlands Cancer Institute (NKI-AvL)](https://onco.cc/institutions/nki/)
- terms: [Event-free / disease-free survival (EFS, DFS, iDFS, RFS)](https://onco.cc/terms/efs/), [Major pathological response (MPR)](https://onco.cc/terms/major-pathological-response/), [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/)
- people: [Christian Blank](https://onco.cc/people/christian-blank/), [Georgina V. Long](https://onco.cc/people/georgina-long/)
- key papers: [NADINA: two doses of ipilimumab plus nivolumab before surgery beat a year of nivolumab after surgery in stage III melanoma](https://onco.cc/key-papers/paper-nadina-nejm-2024/)
- pairings: [Neoadjuvant immunotherapy → response-adapted adjuvant](https://onco.cc/pairings/neoadjuvant-io-response-adapted/)
- ideas: [Pre-surgery platform trials that test combinations on pathological response in months](https://onco.cc/ideas/idea-tr2-neoadjuvant-combo-platform/), [Treat the draining lymph node before removing it](https://onco.cc/ideas/idea-bio2-lymph-node-immune-priming/), [Use pre-surgery immunotherapy windows as the field's biomarker engine](https://onco.cc/ideas/idea-bio2-neoadjuvant-biomarker-engine/)
- roadmaps: [Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work](https://onco.cc/roadmaps/surgery-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/nadina.json