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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06153238
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sandoz
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Romania
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Melanoma
Additional Details

Eligible subjects will be randomized in a 1:1:1 ratio to receive either GME751, Food and Drug Administration (FDA)-licensed pembrolizumab (Keytruda-US) or European Union (EU)-authorized pembrolizumab (Keytruda-EU). The maximum study duration for a participant will be approximately 28 weeks including screening. Treatment duration is 24 weeks (4 treatment cycles, each of 6 weeks duration). However, subject should discontinue study participation in case of disease recurrence, unacceptable toxicity or other reasons. Participants who are benefiting from treatment with pembrolizumab without signs of recurrence or unacceptable toxicity will be eligible for continued pembrolizumab treatment via most suitable option based on the respective country regulations.

Arms & Interventions

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.

Interventions

Drug: - GME751

400 mg Q6W, i.v. infusion, over 24 weeks period

Drug: - Keytruda - EU

400 mg Q6W, i.v. infusion, over 24 weeks period

Drug: - Keytruda - US

400 mg Q6W, i.v. infusion, over 24 weeks period

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sandoz Investigational Site, Bucharest, Romania

Status

Recruiting

Address

Sandoz Investigational Site

Bucharest, ,

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