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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06153238.
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.
