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

Description

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.

Conditions

Melanoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Melanoma
Intervention / Treatment

-

Contacts and Locations

Orange

Sandoz Investigational Site, Orange, California, United States, 92868

Clermont

Sandoz Investigational Site, Clermont, Florida, United States, 34711

Orange City

Sandoz Investigational Site, Orange City, Florida, United States, 32763

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sandoz,

Study Record Dates

2026-07