{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:28:18Z","timestamp":1792787298637,"version":"4.5.0"},"reference-count":50,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T00:00:00Z","timestamp":1772496000000},"content-version":"unspecified","delay-in-days":2,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100017397","name":"UVA Cancer Center","doi-asserted-by":"publisher","award":["Rebecca Harris Fellowship (EKN)"],"award-info":[{"award-number":["Rebecca Harris Fellowship (EKN)"]}],"id":[{"id":"10.13039\/100017397","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Philanthropic Gift","award":["Alice and Bill Goodwin"],"award-info":[{"award-number":["Alice and Bill Goodwin"]}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["2P30 CA044579"],"award-info":[{"award-number":["2P30 CA044579"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000005","name":"U.S. Department of Defense","doi-asserted-by":"publisher","award":["Translational Team Science Award CA181046"],"award-info":[{"award-number":["Translational Team Science Award CA181046"]}],"id":[{"id":"10.13039\/100000005","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2026,2,9]]},"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      For patients with high-risk melanoma who are unresponsive or intolerant to immune checkpoint inhibitors, cancer vaccines may provide benefit with a favorable toxicity profile. CD4\n                      <jats:sup>+<\/jats:sup>\n                      T cells provide essential help to dendritic cells (DCs) for optimal CD8\n                      <jats:sup>+<\/jats:sup>\n                      T cell priming in the antitumor response, and induction of tumor-cognate CD4\n                      <jats:sup>+<\/jats:sup>\n                      T cell responses may enhance vaccine efficacy. We report on a first-in-human approach to treat patients with high-risk melanoma using a vaccine composed of six non-mutated melanoma-specific helper peptides (6MHP) and a shared mutated BRAF-V600E neoantigen helper peptide (mBRAF) co-administered locally with a TLR3 agonist (poly-ICLC) and agonistic CD40 antibody (CDX-1140).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Adults with high-risk melanoma arising from cutaneous, mucosal, or ocular primary sites who were rendered clinically free of disease after definitive treatment were enrolled to this nonrandomized phase I\/II trial (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04364230\">NCT04364230<\/jats:ext-link>\n                      ) designed to assess safety and immunogenicity. Participants received vaccine (6MHP+mBRAF+poly-ICLC) with a dose-escalation allocation of CDX-1140 into the vaccine mixture at one of four dose levels (50, 200, 800, 3000 \u03bcg). Vaccines were administered at 3-week intervals for four doses. Primary endpoints were safety and peripheral CD4\n                      <jats:sup>+<\/jats:sup>\n                      T cell response. Exploratory analysis to characterize the vaccine site microenvironment was performed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 22 eligible participants, 11 (50%) had ocular melanoma. Sixteen (73%) received the maximum CDX-1140 dose. Toxicities were limited to grade 1 or 2 treatment-related adverse events, with no dose-limiting toxicities reported. Peripheral CD4\n                      <jats:sup>+<\/jats:sup>\n                      T cell responses to 6MHP were found ex vivo in six (27%, 95%\u2009CI 11% to 50%), including four with the maximum CDX-1140 dose. One had a durable and persistent T cell response to week 25. T cell responses to mBRAF did not meet criteria for positivity ex vivo, but one participant had a durable response after in vitro stimulation, with expansion of multifunctional Th1-polarized CD4\n                      <jats:sup>+<\/jats:sup>\n                      T cells. Favorable immune-related changes were observed at the vaccine site, including CDX-1140-mediated increases in mature (DC-LAMP\n                      <jats:sup>+<\/jats:sup>\n                      ) DCs.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      The vaccine was safe, well-tolerated, and immunogenic. Optimization of vaccines that include agonistic CD40 antibody is needed to enhance immunogenicity. Induction of a multifunctional CD4\n                      <jats:sup>+<\/jats:sup>\n                      T cell response to mBRAF supports targeting shared mutated neoantigens with melanoma vaccines.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04364230\">NCT04364230<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/jitc-2025-013613","type":"journal-article","created":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T13:15:42Z","timestamp":1772543742000},"page":"e013613","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Phase I\/II clinical trial of a melanoma vaccine targeting shared non-mutated antigens and a shared mutated BRAF neoantigen with an agonistic CD40 antibody (CDX-1140) plus TLR3 agonist (poly-ICLC)"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct04364230","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04364230","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04364230","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-2973-9883","authenticated-orcid":false,"given":"Emily K","family":"Ninmer","sequence":"first","affiliation":[{"name":"Department of Surgery\/Division of Surgical Oncology, University of Virginia Health System, Charlottesville, Virginia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gina R","family":"Petroni","sequence":"additional","affiliation":[{"name":"Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian R","family":"Gastman","sequence":"additional","affiliation":[{"name":"Plastic Surgery, Cleveland Clinic, Cleveland, Ohio, USA"},{"name":"Iovance Biotherapeutics Inc, San Carlos, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth M","family":"Gaughan","sequence":"additional","affiliation":[{"name":"Department of Medicine\/Division of Hematology\/Oncology, University of Virginia Health System, Charlottesville, Virginia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James M","family":"Isaacs","sequence":"additional","affiliation":[{"name":"Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen","family":"Haden","sequence":"additional","affiliation":[{"name":"Department of Surgery\/Division of Surgical Oncology, University of Virginia Health System, Charlottesville, Virginia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Varinder","family":"Kaur","sequence":"additional","affiliation":[{"name":"Department of Medicine\/Division of Hematology\/Oncology, University of Virginia Health System, Charlottesville, Virginia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nolan A","family":"Wages","sequence":"additional","affiliation":[{"name":"Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA"},{"name":"Present Affiliation: Department of Biostatistics, School of Public Health, Virginia Commonwealth University, Richmond, Virginia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly A","family":"Chianese-Bullock","sequence":"additional","affiliation":[{"name":"Department of Surgery\/Division of Surgical Oncology, University of Virginia Health System, Charlottesville, 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