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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153238
• Other study ID #: CGME751A12101
• Status: Recruiting
• Phase: Phase 1
• Start date: May 15, 2024
• Est. completion date: June 20, 2025

Study information

• Verified date: March 2024
• Source: Sandoz
• Contact: Clinical Disclosure Representative
• Phone: +49 8024 / 908 0
• Email: sandoz.disclosure[@]sandoz.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318
• Est. completion date: June 20, 2025
• Est. primary completion date: June 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• GME751
400 mg Q6W, i.v. infusion, over 24 weeks period
• Keytruda - EU
400 mg Q6W, i.v. infusion, over 24 weeks period
• Keytruda - US
400 mg Q6W, i.v. infusion, over 24 weeks period

Locations

Country	Name	City	State
Romania	Sandoz Investigational Site	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

Romania, 

Outcome

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