ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-05-15

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06153238

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Sandoz Investigational Site

Orange, California, 92868

United States

Sandoz Investigational Site

Clermont, Florida, 34711

United States

Sandoz Investigational Site

Orange City, Florida, 32763

United States

Collaborators and Investigators

Sponsor: Sandoz

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-15

Study Completion Date2026-06

Study Record Updates

Study Start Date2024-05-15

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Melanoma