Overview

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

Status:
Recruiting

Trial end date:
2025-06-20

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Sandoz

Treatments:

Pembrolizumab