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

May 27, 2026 updated by: Sandoz

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

322

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina
        • Sandoz Investigational Site
      • Mostar, Bosnia and Herzegovina
        • Sandoz Investigational Site
      • Sarajevo, Bosnia and Herzegovina
        • Sandoz Investigational Site
      • Tuzla, Bosnia and Herzegovina
        • Sandoz Investigational Site
  • Brazil
      • Barretos, Brazil
        • Sandoz Investigational Site
      • Belo Horizonte, Brazil
        • Sandoz Investigational Site
      • Canoas, Brazil
        • Sandoz Investigational Site
      • Caxias do Sul, Brazil
        • Sandoz Investigational Site
      • Curitiba, Brazil
        • Sandoz Investigational Site
      • Florianópolis, Brazil
        • Sandoz Investigational Site
      • Fortaleza, Brazil
        • Sandoz Investigational Site
      • Itajaí, Brazil
        • Sandoz Investigational Site
      • Porto Alegre, Brazil
        • Sandoz Investigational Site
      • Porto Velho, Brazil
        • Sandoz Investigational Site
      • Salvador, Brazil
        • Sandoz Investigational Site
      • São José do Rio Preto, Brazil
        • Sandoz Investigational Site
  • France
      • Besançon, France
        • Sandoz Investigational Site
      • Nantes, France
        • Sandoz Investigational Site
  • Georgia
      • Batumi, Georgia
        • Sandoz Investigational Site
      • Tbilisi, Georgia
        • Sandoz Investigational Site
  • Germany
      • Mainz, Germany
        • Sandoz Investigational Site
      • Münster, Germany
        • Sandoz Investigational Site
      • Tübingen, Germany
        • Sandoz Investigational Site
  • Italy
      • Catanzaro, Italy
        • Sandoz Investigational Site
      • Rozzano, Italy
        • Sandoz Investigational Site
  • Lithuania
      • Klaipėda, Lithuania
        • Sandoz Investigational Site
      • Vilnius, Lithuania
        • Sandoz Investigational Site
  • Malaysia
      • George Town, Malaysia
        • Sandoz Investigational Site
      • Johor Bahru, Malaysia
        • Sandoz Investigational Site
      • Kuala Lumpur, Malaysia
        • Sandoz Investigational Site
      • Kuching, Malaysia
        • Sandoz Investigational Site
      • Malacca, Malaysia
        • Sandoz Investigational Site
      • Putrajaya, Malaysia
        • Sandoz Investigational Site
  • Mexico
      • Mexico City, Mexico
        • Sandoz Investigational Site
      • Oaxaca City, Mexico
        • Sandoz Investigational Site
      • San Luis Potosí City, Mexico
        • Sandoz Investigational Site
      • Veracruz, Mexico
        • Sandoz Investigational Site
  • Moldova
      • Chisinau, Moldova
        • Sandoz Investigational Site
  • North Macedonia
      • Skopje, North Macedonia
        • Sandoz Investigational Site
  • Philippines
      • Bacolod, Philippines
        • Sandoz Investigational Site
  • Romania
      • Bucharest, Romania
        • Sandoz Investigational Site
      • Cluj-Napoca, Romania
        • Sandoz Investigational Site
  • Serbia
      • Belgrade, Serbia
        • Sandoz Investigational Site
      • Kamenitz, Serbia
        • Sandoz Investigational Site
      • Niš, Serbia
        • Sandoz Investigational Site
  • South Africa
      • Johannesburg, South Africa
        • Sandoz Investigational Site
      • Phoenix, South Africa
        • Sandoz Investigational Site
  • Spain
      • Badalona, Spain
        • Sandoz Investigational Site
      • Barcelona, Spain
        • Sandoz Investigational Site
      • Cáceres, Spain
        • Sandoz Investigational Site
      • Madrid, Spain
        • Sandoz Investigational Site
      • Murcia, Spain
        • Sandoz Investigational Site
      • Santiago de Compostela, Spain
        • Sandoz Investigational Site
      • Seville, Spain
        • Sandoz Investigational Site
      • Valencia, Spain
        • Sandoz Investigational Site
      • Zaragoza, Spain
        • Sandoz Investigational Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Sandoz Investigational Site
      • Yüreğir, Turkey (Türkiye)
        • Sandoz Investigational Site
  • United States
    • California
      • Orange, California, United States, 92868
        • Sandoz Investigational Site
    • Florida
      • Clermont, Florida, United States, 34711
        • Sandoz Investigational Site
      • Orange City, Florida, United States, 32763
        • Sandoz Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GME751
Subjects will receive GME751 via intravenous (IV) infusion.
Drug: GME751
400 mg Q6W, i.v. infusion, over 24 weeks period
Active Comparator: Keytruda - EU
Subjects will receive Keytruda-EU via intravenous (IV) infusion.
Drug: Keytruda - EU
400 mg Q6W, i.v. infusion, over 24 weeks period
Active Comparator: Keytruda - US
Subjects will receive Keytruda-US via intravenous (IV) infusion.
Drug: Keytruda - US
400 mg Q6W, i.v. infusion, over 24 weeks period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d)
Time Frame: 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.
Day 1 (Postdose) through Day 42
Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State
Time Frame: 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.
Week 19 through Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Actual)

December 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGME751A12101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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