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

Phase 1

Recruiting

• Conditions: Melanoma
• Interventions: Drug: GME751; Drug: Keytruda - US; Drug: Keytruda - EU

• Registration Number: NCT06153238
• Lead Sponsor: Sandoz

Brief 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.

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-11-22
• Study First Posted: 2023-12-01
• Study Start: 2024-05-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 318

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GME751	GME751	Subjects will receive GME751 via intravenous (IV) infusion.
Keytruda - US	Keytruda - US	Subjects will receive Keytruda-US via intravenous (IV) infusion.
Keytruda - EU	Keytruda - EU	Subjects will receive Keytruda-EU via intravenous (IV) infusion.

Primary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d)	Day 1 (Postdose) through Day 42	The PK similarity (AUC0-42d) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State	Week 19 through Week 24	The PK similarity (AUCtau_ss) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.

Trial Locations

Locations (1)

Sandoz Investigational Site; 🇹🇷 Ankara, Turkey