{"entity":{"id":"interpath-001","kind":"trial","name":"INTerpath-001 (V940-001)","aka":[],"tldr":"INTerpath-001 was the first positive phase 3 trial of a personalised cancer vaccine, announced 19 August 2026.","summary":"INTerpath-001, also V940-001, trial NCT05933577 sponsored by Moderna and Merck and announced on 19 August 2026, was the first positive phase 3 trial of a personalised cancer vaccine, testing intismeran autogene plus pembrolizumab against pembrolizumab alone after resection of stage IIB to IV melanoma. It randomised 1,137 patients, met its primary recurrence-free survival endpoint and its key secondary distant metastasis-free survival endpoint with no new safety signals, and full data are expected at a late-2026 congress with filings to follow; sister trials run in lung, kidney, bladder and skin squamous cancers. It confirms the phase 2b KEYNOTE-942 signal, and whether the effect size justifies bespoke manufacturing for every patient is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05933577","url":"https://clinicaltrials.gov/study/NCT05933577"},{"label":"Merck press release","url":"https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/"}],"tags":[],"related":[],"cancers":["melanoma","stage-iii-melanoma","stage-ii-melanoma"],"sections":[],"technologies":["neoantigen-mrna-vaccine"],"targets":[],"drugs":["intismeran-autogene","pembrolizumab"],"companies":["moderna"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["jeffrey-weber"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05933577","phase":"3","setting":"Adjuvant resected stage IIB-IV melanoma: intismeran autogene + pembrolizumab vs pembrolizumab","sponsor":"Moderna / Merck","result":"RFS and DMFS significantly improved (HRs pending presentation).","started":"2023-07-19","startedType":"actual","yearReported":2026,"enrolled":1137,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival","primary":true,"arms":[{"name":"Intismeran autogene + pembrolizumab","note":"Met; hazard ratio and medians not yet disclosed (topline 19 August 2026)."},{"name":"Placebo + pembrolizumab"}],"source":"https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/"},{"endpoint":"Distant metastasis-free survival","arms":[{"name":"Intismeran autogene + pembrolizumab","note":"Met; numbers pending presentation."},{"name":"Placebo + pembrolizumab"}]}],"replication":"Confirms the phase 2b KEYNOTE-942 signal (RFS HR 0.51 at 3 years) in a randomised phase 3; full data pending."},"route":"/trials/interpath-001/","neighbours":{"cancer":[{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"stage-ii-melanoma","kind":"cancer","name":"Stage IIB and IIC melanoma","route":"/cancers/stage-ii-melanoma/"},{"id":"stage-iii-melanoma","kind":"cancer","name":"Stage III melanoma (after surgery)","route":"/cancers/stage-iii-melanoma/"}],"technology":[{"id":"neoantigen-mrna-vaccine","kind":"technology","name":"Personalised neoantigen (mRNA) vaccines","route":"/technologies/neoantigen-mrna-vaccine/"}],"drug":[{"id":"intismeran-autogene","kind":"drug","name":"Intismeran autogene","route":"/drugs/intismeran-autogene/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"moderna","kind":"company","name":"Moderna","route":"/companies/moderna/"}],"person":[{"id":"jeffrey-weber","kind":"person","name":"Jeffrey S. Weber","route":"/people/jeffrey-weber/"}],"term":[{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"}],"pairing":[{"id":"vaccine-plus-pd1","kind":"pairing","name":"Personalised neoantigen vaccine + PD-1 blockade","route":"/pairings/vaccine-plus-pd1/"}],"roadmap":[{"id":"immunotherapy-roadmap","kind":"roadmap","name":"Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity","route":"/roadmaps/immunotherapy-roadmap/"}],"bottleneck":[{"id":"b-tme-immunosuppression","kind":"bottleneck","name":"Cold tumours and the immunosuppressive microenvironment","route":"/bottlenecks/b-tme-immunosuppression/"}],"idea":[{"id":"idea-bio1-clonal-neoantigen-vaccines","kind":"idea","name":"Vaccines aimed only at mutations shared by every tumour cell","route":"/ideas/idea-bio1-clonal-neoantigen-vaccines/"}],"paper":[{"id":"paper-keynote-942-lancet-2024","kind":"paper","name":"KEYNOTE-942: a personalised mRNA cancer vaccine plus pembrolizumab after melanoma surgery","route":"/key-papers/paper-keynote-942-lancet-2024/"},{"id":"paper-rojas-mrna-neoantigen-vaccine-pancreatic-nature-2023","kind":"paper","name":"Rojas 2023: a personalised mRNA vaccine trained T cells against each patient's pancreatic cancer, and those who responded stayed cancer-free longer","route":"/key-papers/paper-rojas-mrna-neoantigen-vaccine-pancreatic-nature-2023/"}]}}