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Patients with low intra-tumoral interferon-\u03b3 (IFN-\u03b3) signatures are less likely to benefit. We show that domatinostat (a class I histone deacetylase inhibitor) addition to anti-PD-1 + anti-CTLA-4 increased the IFN-\u03b3 response and reduced tumor growth in our murine melanoma model, rationalizing evaluation in patients. To stratify patients into IFN-\u03b3 high and low cohorts, we developed a baseline IFN-\u03b3 signature expression algorithm, which was prospectively tested in the DONIMI trial. Patients with stage III melanoma and high intra-tumoral IFN-\u03b3 scores were randomized to neoadjuvant nivolumab or nivolumab + domatinostat, while patients with low IFN-\u03b3 scores received nivolumab + domatinostat or ipilimumab + nivolumab + domatinostat. Domatinostat addition to neoadjuvant nivolumab \u00b1 ipilimumab did not delay surgery but induced unexpected severe skin toxicity, hampering domatinostat dose escalation. At studied dose levels, domatinostat addition did not increase treatment efficacy. The baseline IFN-\u03b3 score adequately differentiated patients who were likely to benefit from nivolumab alone versus patients who require other therapies.<\/jats:p>","DOI":"10.1084\/jem.20221952","type":"journal-article","created":{"date-parts":[[2023,2,3]],"date-time":"2023-02-03T02:21:03Z","timestamp":1675390863000},"update-policy":"https:\/\/doi.org\/10.1084\/jem.crossmarkpolicy","source":"Crossref","is-referenced-by-count":83,"title":["IFN-\u03b3 signature enables selection of neoadjuvant treatment in patients with stage III melanoma"],"prefix":"10.1084","volume":"220","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7103-3219","authenticated-orcid":true,"given":"Irene L.M.","family":"Reijers","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03xqtf034","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Medical Oncology, Netherlands Cancer Institute 1 , Amsterdam, 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