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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• At least 18 years of age

• Advanced Melanoma

• Completely removed melanoma by surgery performed within 13 weeks of randomization

• Adequate organ function

• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

• Known history or evidence of ocular or uveal melanoma

• Known history of hypersensitivity (grade ≥3) to pembrolizumab or its excipients

• Known History of auto-immune disease

• Received live vaccine ≤30 days before the first study treatment

• Prior treatment with anti-PD-1 agents or agent against another stimulatory or co-inhibitory T cell receptor

• Active autoimmune disease that has necessitated chronic systemic treatment within 2 years before the first study treatment

Other protocol-defined inclusion/exclusion criteria apply