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

NCT06153238 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CGME751A12101
• Study Type: interventional
• Target: 322
• Locations: 18 countries
• Sites: 61

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

GME751

EXPERIMENTAL

Subjects will receive GME751 via intravenous (IV) infusion.

Drug: GME751

Keytruda - EU

ACTIVE COMPARATOR

Subjects will receive Keytruda-EU via intravenous (IV) infusion.

Drug: Keytruda - EU

Keytruda - US

ACTIVE COMPARATOR

Subjects will receive Keytruda-US via intravenous (IV) infusion.

Drug: Keytruda - US

Interventions

GME751 DRUG

400 mg Q6W, i.v. infusion, over 24 weeks period

GME751

Keytruda - EU DRUG

400 mg Q6W, i.v. infusion, over 24 weeks period

Keytruda - EU

Keytruda - US DRUG

400 mg Q6W, i.v. infusion, over 24 weeks period

Keytruda - US

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sandoz: lead

Study Sites (61)

Sandoz Investigational Site

Orange, California, 92868, United States

Location

Sandoz Investigational Site

Clermont, Florida, 34711, United States

Location

Sandoz Investigational Site

Orange City, Florida, 32763, United States

Location

Sandoz Investigational Site

Banja Luka, Bosnia and Herzegovina

Location

Sandoz Investigational Site

Mostar, Bosnia and Herzegovina

Location

Sandoz Investigational Site

Sarajevo, Bosnia and Herzegovina

Location

Sandoz Investigational Site

Tuzla, Bosnia and Herzegovina

Location

Sandoz Investigational Site

Barretos, Brazil

Location

Sandoz Investigational Site

Belo Horizonte, Brazil

Location

Sandoz Investigational Site

Canoas, Brazil

Location

Sandoz Investigational Site

Caxias do Sul, Brazil

Location

Sandoz Investigational Site

Curitiba, Brazil

Location

Sandoz Investigational Site

Florianópolis, Brazil

Location

Sandoz Investigational Site

Fortaleza, Brazil

Location

Sandoz Investigational Site

Itajaí, Brazil

Location

Sandoz Investigational Site

Porto Alegre, Brazil

Location

Sandoz Investigational Site

Porto Velho, Brazil

Location

Sandoz Investigational Site

Salvador, Brazil

Location

Sandoz Investigational Site

São José do Rio Preto, Brazil

Location

Sandoz Investigational Site

Besançon, France

Location

Sandoz Investigational Site

Nantes, France

Location

Sandoz Investigational Site

Batumi, Georgia

Location

Sandoz Investigational Site

Tbilisi, Georgia

Location

Sandoz Investigational Site

Mainz, Germany

Location

Sandoz Investigational Site

Münster, Germany

Location

Sandoz Investigational Site

Tübingen, Germany

Location

Sandoz Investigational Site

Catanzaro, Italy

Location

Sandoz Investigational Site

Rozzano, Italy

Location

Sandoz Investigational Site

Klaipėda, Lithuania

Location

Sandoz Investigational Site

Vilnius, Lithuania

Location

Sandoz Investigational Site

George Town, Malaysia

Location

Sandoz Investigational Site

Johor Bahru, Malaysia

Location

Sandoz Investigational Site

Kuala Lumpur, Malaysia

Location

Sandoz Investigational Site

Kuching, Malaysia

Location

Sandoz Investigational Site

Malacca, Malaysia

Location

Sandoz Investigational Site

Putrajaya, Malaysia

Location

Sandoz Investigational Site

Mexico City, Mexico

Location

Sandoz Investigational Site

Oaxaca City, Mexico

Location

Sandoz Investigational Site

San Luis Potosí City, Mexico

Location

Sandoz Investigational Site

Veracruz, Mexico

Location

Sandoz Investigational Site

Chisinau, Moldova

Location

Sandoz Investigational Site

Skopje, North Macedonia

Location

Sandoz Investigational Site

Bacolod, Philippines

Location

Sandoz Investigational Site

Bucharest, Romania

Location

Sandoz Investigational Site

Cluj-Napoca, Romania

Location

Sandoz Investigational Site

Belgrade, Serbia

Location

Sandoz Investigational Site

Kamenitz, Serbia

Location

Sandoz Investigational Site

Niš, Serbia

Location

Sandoz Investigational Site

Johannesburg, South Africa

Location

Sandoz Investigational Site

Phoenix, South Africa

Location

Sandoz Investigational Site

Badalona, Spain

Location

Sandoz Investigational Site

Barcelona, Spain

Location

Sandoz Investigational Site

Cáceres, Spain

Location

Sandoz Investigational Site

Madrid, Spain

Location

Sandoz Investigational Site

Murcia, Spain

Location

Sandoz Investigational Site

Santiago de Compostela, Spain

Location

Sandoz Investigational Site

Seville, Spain

Location

Sandoz Investigational Site

Valencia, Spain

Location

Sandoz Investigational Site

Zaragoza, Spain

Location

Sandoz Investigational Site

Ankara, Turkey (Türkiye)

Location

Sandoz Investigational Site

Yüreğir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: December 1, 2023
• Study Start: May 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); PH (1); US (3); BR (12); ZA (2); ME (4); SE (3); LI (2); ES (9); TU (2); DE (3); RO (2); BO (4); MO (1); MY (6); GE (2); NO (1); FR (2)