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NCT06153238CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
322 (actual)
First submitted
11 Oct 2023
Start date
15 May 2024
Primary completion date
5 May 2026
Lead sponsor
Sandoz
Diseases
Melanoma
NCT number
NCT06153238

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 322
  • From 15 May 2024 to the primary completion date, 5 May 2026
  • 61 sites in 18 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Known history of hypersensitivity (grade ≥3) to pembrolizumab or its excipients
  • Known History of auto-immune disease
  • Active autoimmune disease that has necessitated chronic systemic treatment within 2 years before the first study treatment
    • Other protocol-defined inclusion/exclusion criteria apply

Other

  • Known history or evidence of ocular or uveal melanoma

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sandoz Investigational Site
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BarretosBrazilUnknown status
Sandoz Investigational Site
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Belo HorizonteBrazilUnknown status
Sandoz Investigational Site
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CanoasBrazilUnknown status
Sandoz Investigational Site
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Caxias do SulBrazilUnknown status
Sandoz Investigational Site
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CuritibaBrazilUnknown status
Sandoz Investigational Site
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FlorianópolisBrazilUnknown status
Sandoz Investigational Site
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FortalezaBrazilUnknown status
Sandoz Investigational Site
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ItajaíBrazilUnknown status
Sandoz Investigational Site
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Porto AlegreBrazilUnknown status
Sandoz Investigational Site
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Porto VelhoBrazilUnknown status
Sandoz Investigational Site
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SalvadorBrazilUnknown status
Sandoz Investigational Site
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São José do Rio PretoBrazilUnknown status
Sandoz Investigational Site
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MainzGermanyUnknown status
Sandoz Investigational Site
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MünsterGermanyUnknown status
Sandoz Investigational Site
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TübingenGermanyUnknown status
Sandoz Investigational Site
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BadalonaSpainUnknown status
Sandoz Investigational Site
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BarcelonaSpainUnknown status
Sandoz Investigational Site
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CáceresSpainUnknown status
Sandoz Investigational Site
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MadridSpainUnknown status
Sandoz Investigational Site
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MurciaSpainUnknown status
Sandoz Investigational Site
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Santiago de CompostelaSpainUnknown status
Sandoz Investigational Site
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SevilleSpainUnknown status
Sandoz Investigational Site
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ValenciaSpainUnknown status
Sandoz Investigational Site
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ZaragozaSpainUnknown status
Sandoz Investigational Site
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BesançonFranceUnknown status
Sandoz Investigational Site
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NantesFranceUnknown status
Sandoz Investigational Site
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BatumiGeorgiaUnknown status
Sandoz Investigational Site
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TbilisiGeorgiaUnknown status
Sandoz Investigational Site
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CatanzaroItalyUnknown status
Sandoz Investigational Site
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RozzanoItalyUnknown status
Sandoz Investigational Site
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KlaipėdaLithuaniaUnknown status
Sandoz Investigational Site
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VilniusLithuaniaUnknown status
Sandoz Investigational Site
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ChisinauMoldovaUnknown status
Sandoz Investigational Site
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SkopjeNorth MacedoniaUnknown status
Sandoz Investigational Site
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Mexico CityMexicoUnknown status
Sandoz Investigational Site
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Oaxaca CityMexicoUnknown status
Sandoz Investigational Site
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San Luis Potosí CityMexicoUnknown status
Sandoz Investigational Site
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VeracruzMexicoUnknown status
Sandoz Investigational Site
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George TownMalaysiaUnknown status
Sandoz Investigational Site
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Johor BahruMalaysiaUnknown status
Sandoz Investigational Site
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Kuala LumpurMalaysiaUnknown status
Sandoz Investigational Site
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KuchingMalaysiaUnknown status
Sandoz Investigational Site
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MalaccaMalaysiaUnknown status
Sandoz Investigational Site
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PutrajayaMalaysiaUnknown status
Sandoz Investigational Site
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BacolodPhilippinesUnknown status
Sandoz Investigational Site
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BucharestRomaniaUnknown status
Sandoz Investigational Site
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Cluj-NapocaRomaniaUnknown status
Sandoz Investigational Site
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BelgradeSerbiaUnknown status
Sandoz Investigational Site
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KamenitzSerbiaUnknown status
Sandoz Investigational Site
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NišSerbiaUnknown status
Sandoz Investigational Site
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ClermontUnited StatesUnknown status
Sandoz Investigational Site
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OrangeUnited StatesUnknown status
Sandoz Investigational Site
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Orange CityUnited StatesUnknown status
Sandoz Investigational Site
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JohannesburgSouth AfricaUnknown status
Sandoz Investigational Site
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PhoenixSouth AfricaUnknown status
Sandoz Investigational Site
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AnkaraTurkey (Türkiye)Unknown status
Sandoz Investigational Site
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Banja LukaBosnia and HerzegovinaUnknown status
Sandoz Investigational Site
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MostarBosnia and HerzegovinaUnknown status
Sandoz Investigational Site
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SarajevoBosnia and HerzegovinaUnknown status
Sandoz Investigational Site
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TuzlaBosnia and HerzegovinaUnknown status
Sandoz Investigational Site
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YüreğirTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.