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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06153238
Recruitment Status : Not yet recruiting
First Posted : December 1, 2023
Last Update Posted : March 27, 2024
Sponsor:
Information provided by (Responsible Party):
Sandoz

Study Description
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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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: GME751 Drug: Keytruda - EU Drug: Keytruda - US Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 26, 2024
Estimated Primary Completion Date : June 20, 2025
Estimated Study Completion Date : June 20, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06153238


Contacts
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Contact: Clinical Disclosure Representative +49 8024 / 908 0 sandoz.disclosure@sandoz.com

Sponsors and Collaborators
Sandoz
More Information
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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT06153238    
Other Study ID Numbers: CGME751A12101
First Posted: December 1, 2023    Key Record Dates
Last Update Posted: March 27, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
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
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action