NCT06153238Not yet recruiting

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

Name: Clinical Trial NCT06153238
Creator: Sandoz
Keywords: Melanoma, GME751, Phase 1, drug, clinical trial

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

SandozPhase 1ClinicalTrials.govdrug

Verified

Study focus

Disease/Condition: Melanoma
Drug/Device/Intervention: GME751
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Sandoz

Timeline & enrollment

Phase: Phase 1
Start date: Feb 28, 2024
End date: Jun 20, 2025
Enrollment: 318 participants

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

Malignant melanoma of skinMelanoma in situ, unspecifiedMelanoma in situMelanoma and other malignant neoplasms of skinMalignant neoplasm: Malignant melanoma of skin, unspecified

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06153238
Type: Non-Device Trial

About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.