NCT06153238

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

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics of GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU Authorized Keytruda® in Participants With Stage II and III Melanoma Requiring Adjuvant Treatment With Pembrolizumab

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible subjects will be randomized in a 1:1:1 ratio to receive either GME751, Food and Drug Administration (FDA)-licensed pembrolizumab (Keytruda-US) or European Union (EU)-authorized pembrolizumab (Keytruda-EU). The maximum study duration for a participant will be approximately 28 weeks including screening. Treatment duration is 24 weeks (4 treatment cycles, each of 6 weeks duration). However, subject should discontinue study participation in case of disease recurrence, unacceptable toxicity or other reasons. Participants who are benefiting from treatment with pembrolizumab without signs of recurrence or unacceptable toxicity will be eligible for continued pembrolizumab treatment via most suitable option based on the respective country regulations.

Conditions

• Melanoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-05-15
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-12-01
• Last updated: 2026-02-05

Locations

61 sites across 18 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)

Regulatory

• FDA-regulated drug study