A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma - Trial NCT06153238
Access comprehensive clinical trial information for NCT06153238 through Pure Global AI's free database. This Phase 1 trial is sponsored by Sandoz and is currently Not yet recruiting. The study focuses on Melanoma. Target enrollment is 318 participants.
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Study Focus
Sponsor & Location
Sandoz
Timeline & Enrollment
Phase 1
Feb 28, 2024
Jun 20, 2025
Primary Outcome
Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d),Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06153238
Non-Device Trial