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A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma

NCT06153238 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2026-04-23

No results posted yet for this study

Summary

The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring adjuvant treatment with pembrolizumab.

Conditions

Interventions

DRUG

GME751

400 mg Q6W, i.v. infusion, over 24 weeks period

DRUG

Keytruda - EU

400 mg Q6W, i.v. infusion, over 24 weeks period

DRUG

Keytruda - US

400 mg Q6W, i.v. infusion, over 24 weeks period

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Bosnia and Herzegovina
  • Brazil
  • France
  • Georgia
  • Germany
  • Italy
  • Lithuania
  • Malaysia
  • Mexico
  • Moldova
  • North Macedonia
  • Philippines
  • Romania
  • Serbia
  • South Africa
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06153238 on ClinicalTrials.gov