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
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Completed
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Participants
322
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Lead sponsor
Sandoz
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Start date
2024-05-15
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Number of sites
61
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma
clinicaltrials.gov
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2026-05-05
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First posted
2023-12-01
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Registry last updated
2026-07-07
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Primary completion date
2026-05-05
clinicaltrials.gov
Start date
2024-05-15
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Actual participants
322
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Participants
322
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Participant count basis
Actual
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Protocol amendments
1
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Randomisation ratio
1:1:1
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Number of sites
61
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sandoz
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06153238
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06153238
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d)

    Timeframe: 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

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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

Sources for eligibility
clinicaltrials.gov

  • Sandoz Investigational SiteOrange, United States
  • Sandoz Investigational SiteClermont, United States
  • Sandoz Investigational SiteOrange City, United States
  • Sandoz Investigational SiteBanja Luka, Bosnia and Herzegovina
  • Sandoz Investigational SiteMostar, Bosnia and Herzegovina
  • Sandoz Investigational SiteSarajevo, Bosnia and Herzegovina
  • Sandoz Investigational SiteTuzla, Bosnia and Herzegovina
  • Sandoz Investigational SiteBarretos, Brazil
  • Sandoz Investigational SiteBelo Horizonte, Brazil
  • Sandoz Investigational SiteCanoas, Brazil
  • Sandoz Investigational SiteCaxias do Sul, Brazil
  • Sandoz Investigational SiteCuritiba, Brazil
  • Sandoz Investigational SiteFlorianópolis, Brazil
  • Sandoz Investigational SiteFortaleza, Brazil
  • Sandoz Investigational SiteItajaí, Brazil
  • Sandoz Investigational SitePorto Alegre, Brazil
  • Sandoz Investigational SitePorto Velho, Brazil
  • Sandoz Investigational SiteSalvador, Brazil
  • Sandoz Investigational SiteSão José do Rio Preto, Brazil
  • Sandoz Investigational SiteBesançon, France
  • Sandoz Investigational SiteNantes, France
  • Sandoz Investigational SiteBatumi, Georgia
  • Sandoz Investigational SiteTbilisi, Georgia
  • Sandoz Investigational SiteMainz, Germany
  • Sandoz Investigational SiteMünster, Germany

And 36 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)