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

Part of paid clinical trials in Orange, California.

Sponsor
Sandoz
Study ID
NCT06153238
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GME751 — DRUG
    400 mg Q6W, i.v. infusion, over 24 weeks period
  • Keytruda - EU — DRUG
    400 mg Q6W, i.v. infusion, over 24 weeks period
  • Keytruda - US — DRUG
    400 mg Q6W, i.v. infusion, over 24 weeks period

Study Details

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.

Key Dates

Start date
May 15, 2024
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
322 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GME751
    Subjects will receive GME751 via intravenous (IV) infusion.
  • Active Comparator: Keytruda - EU
    Subjects will receive Keytruda-EU via intravenous (IV) infusion.
  • Active Comparator: Keytruda - US
    Subjects will receive Keytruda-US via intravenous (IV) infusion.

Primary Outcome Measure

Area Under the Serum Concentration-time Curve from Time Zero to 42 Days (AUC0-42d) [ Time Frame: Day 1 (Postdose) through Day 42 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Sandoz Investigational SiteOrangeCalifornia92868-
Sandoz Investigational SiteClermontFlorida34711-
Sandoz Investigational SiteOrange CityFlorida32763-

Find similar trials in Orange, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Sandoz Investigational Site· Orange, CASandoz Investigational Site· Clermont, FLSandoz Investigational Site· Orange City, FL

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