{"entity":{"id":"nct02362594","kind":"trial","name":"Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)","aka":["KEYNOTE-054"],"tldr":"A phase 3 trial of Pembrolizumab in melanoma, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054) is a phase 3 interventional study registered as NCT02362594 by Merck Sharp & Dohme LLC, with 1019 participants enrolled, started 2015-07-16 and due to reach its primary completion in 2018-01-08. Interventions recorded: pembrolizumab, placebo. Conditions listed: Melanoma. Results were posted on ClinicalTrials.gov in 2019; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02362594","url":"https://clinicaltrials.gov/study/NCT02362594"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","stage-iii-melanoma"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-keynote-054-eggermont-nejm-2018","paper-nct02362594-lancet-oncol-2021-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02362594","phase":"3","setting":"Adjuvant Immunotherapy With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-risk Stage III Melanoma: A Randomized, Double- Blind Phase 3 Trial of the EORTC Melanoma Group","sponsor":"Merck Sharp & Dohme LLC","started":"2015-07-16","startedType":"actual","yearReported":2019,"enrolled":1019,"enrolledBasis":"registry","outcomes":[{"endpoint":"Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":514,"value":82.2,"note":"95% CI 78.6 to 85.3; Figures from the ClinicalTrials.gov results section (first posted 2019-01-04), not from a publication"},{"name":"Placebo","n":505,"value":73.3,"note":"95% CI 69.2 to 77.0"}],"hr":0.57,"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT02362594?tab=results"},{"endpoint":"Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression","primary":true,"unit":"%","arms":[{"name":"Pembrolizumab","n":428,"value":83.8,"note":"95% CI 80.0 to 87.0; Figures from the ClinicalTrials.gov results section (first posted 2019-01-04), not from a publication"},{"name":"Placebo","n":425,"value":75.4,"note":"95% CI 71.0 to 79.2"}],"hr":0.54,"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT02362594?tab=results"}]},"route":"/trials/nct02362594/","neighbours":{"cancer":[{"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/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"paper":[{"id":"paper-nct02362594-lancet-oncol-2021-update","kind":"paper","name":"Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial","route":"/key-papers/paper-nct02362594-lancet-oncol-2021-update/"},{"id":"paper-keynote-054-eggermont-nejm-2018","kind":"paper","name":"KEYNOTE-054 (EORTC 1325): adjuvant pembrolizumab versus placebo in resected stage III melanoma","route":"/key-papers/paper-keynote-054-eggermont-nejm-2018/"}]}}