# Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)

Source: https://onco.cc/trials/nct02362594/  
OnCo record `nct02362594` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Also known as: KEYNOTE-054
- Tags: ctgov-ingest
- Registry id: 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
- Enrolled: 1019
- Outcomes: Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants: Pembrolizumab 82.2% vs Placebo 73.3%, HR 0.57; Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression: Pembrolizumab 83.8% vs Placebo 75.4%, HR 0.54

## Sources

- ClinicalTrials.gov NCT02362594: https://clinicaltrials.gov/study/NCT02362594

## Connected records

- cancers: [Melanoma](https://onco.cc/cancers/melanoma/), [Stage III melanoma (after surgery)](https://onco.cc/cancers/stage-iii-melanoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)
- key papers: [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](https://onco.cc/key-papers/paper-nct02362594-lancet-oncol-2021-update/), [KEYNOTE-054 (EORTC 1325): adjuvant pembrolizumab versus placebo in resected stage III melanoma](https://onco.cc/key-papers/paper-keynote-054-eggermont-nejm-2018/)

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