{"entity":{"id":"nadina","kind":"trial","name":"NADINA","aka":[],"tldr":"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.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04949113","url":"https://clinicaltrials.gov/study/NCT04949113"},{"label":"NEJM 2024","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2402604"}],"tags":[],"related":[],"cancers":["melanoma","stage-iii-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1","ctla4"],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":["nki"],"pathways":[],"terms":["neoadjuvant-adjuvant","efs","major-pathological-response"],"trials":[],"people":["georgina-long","christian-blank"],"bottlenecks":[],"keyPapers":["paper-nadina-nejm-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"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","result":"12-month EFS 83.7% vs 57.2%; HR 0.32.","started":"2021-07-08","startedType":"actual","yearReported":2024,"enrolled":423,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 12 months","primary":true,"unit":"%","arms":[{"name":"Neoadjuvant ipilimumab + nivolumab","value":83.7},{"name":"Adjuvant nivolumab","value":57.2}],"hr":0.32,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2402604"}],"replication":"SWOG S1801 (neoadjuvant pembrolizumab) independently showed an EFS benefit for the neoadjuvant sequence, with a different drug."},"route":"/trials/nadina/","neighbours":{"cancer":[{"id":"acral-melanoma","kind":"cancer","name":"Acral melanoma","route":"/cancers/acral-melanoma/"},{"id":"braf-v600-melanoma","kind":"cancer","name":"BRAF V600-mutant melanoma","route":"/cancers/braf-v600-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"stage-iii-melanoma","kind":"cancer","name":"Stage III melanoma (after surgery)","route":"/cancers/stage-iii-melanoma/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"ctla4","kind":"target","name":"CTLA-4","route":"/targets/ctla4/"},{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"institution":[{"id":"nki","kind":"institution","name":"Netherlands Cancer Institute (NKI-AvL)","route":"/institutions/nki/"}],"term":[{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"},{"id":"major-pathological-response","kind":"term","name":"Major pathological response (MPR)","route":"/terms/major-pathological-response/"},{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"}],"person":[{"id":"christian-blank","kind":"person","name":"Christian Blank","route":"/people/christian-blank/"},{"id":"georgina-long","kind":"person","name":"Georgina V. Long","route":"/people/georgina-long/"}],"paper":[{"id":"paper-nadina-nejm-2024","kind":"paper","name":"NADINA: two doses of ipilimumab plus nivolumab before surgery beat a year of nivolumab after surgery in stage III melanoma","route":"/key-papers/paper-nadina-nejm-2024/"}],"pairing":[{"id":"neoadjuvant-io-response-adapted","kind":"pairing","name":"Neoadjuvant immunotherapy → response-adapted adjuvant","route":"/pairings/neoadjuvant-io-response-adapted/"}],"idea":[{"id":"idea-tr2-neoadjuvant-combo-platform","kind":"idea","name":"Pre-surgery platform trials that test combinations on pathological response in months","route":"/ideas/idea-tr2-neoadjuvant-combo-platform/"},{"id":"idea-bio2-lymph-node-immune-priming","kind":"idea","name":"Treat the draining lymph node before removing it","route":"/ideas/idea-bio2-lymph-node-immune-priming/"},{"id":"idea-bio2-neoadjuvant-biomarker-engine","kind":"idea","name":"Use pre-surgery immunotherapy windows as the field's biomarker engine","route":"/ideas/idea-bio2-neoadjuvant-biomarker-engine/"}],"roadmap":[{"id":"surgery-roadmap","kind":"roadmap","name":"Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work","route":"/roadmaps/surgery-roadmap/"}]}}