Last updated 33 days ago
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma
318 patients around the world
Available in Brazil, United States
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.
Sandoz
318Patients around the world
This study is for people with
Skin cancer
Melanoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
SponsorSandoz
Study typeInterventional
Conditions
Melanoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06153238
