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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509136-25-00

Acronym

MK3475-054

Enrollment

572

Registered

2024-07-09

Start date

2015-07-16

Completion date

Unknown

Last updated

2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

2010): Stage IIIA with metastasis > 1 mm; any Stage IIIB or IIIC (no in-transit metastases), classified as (AJCC, Stage III melanoma (AJCC R0) with histologically confirmed cutaneous melanoma metastatic to lymph node

Brief summary

♦ Recurrence-free survival (RFS), ♦ RFS for patients with PD-L1-positive expression

Detailed description

♦ Distant metastases-free survival (DMFS), ♦ DMFS for patients with PD-L1-positive expression, ♦ Overall survival (OS), ♦ OS for patients with PD-L1-positive expression, ♦ Pharmacokinetics (PK) of pembrolizumab

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGSaline Solution

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
♦ Recurrence-free survival (RFS), ♦ RFS for patients with PD-L1-positive expression	—

Secondary

Measure	Time frame
♦ Distant metastases-free survival (DMFS), ♦ DMFS for patients with PD-L1-positive expression, ♦ Overall survival (OS), ♦ OS for patients with PD-L1-positive expression, ♦ Pharmacokinetics (PK) of pembrolizumab	—

Countries

Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026