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

Study Identifier:
CGME751A12101
CT.gov Identifier:
NCT06153238
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-506881-30-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

Considering participating in a START clinical trial?

Get Started

Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Melanoma
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: GME751
    • Read More
  • Drug: Active Comparator: Keytruda - EU
  • Drug: Active Comparator: Keytruda - US
  • Drug: INTERVENTIONS
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Manuel Pedregal Trujillo
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Melanoma