This is a multicenter, randomized, double-blind, parallel-group, 2 treatment group, repeated dose study to compare the PK, efficacy, safety, and immunogenicity of AVT32-DRL\_PB (proposed Keytruda® biosimilar) versus Keytruda (pembrolizumab) when administered as monotherapy in participants with fully resected Stage IIB/C or Stage III melanoma requiring adjuvant treatment with pembrolizumab. Eligible participants will be randomized in a 1:1 ratio to the AVT32-DRL\_PB or Keytruda treatment group and stratified by sex (female versus male) and body weight category (≤75 kg versus \>75 kg). Study treatments will be administered every 3 weeks (Q3W) as an intravenous (IV) infusion over 30 minutes (1 administration Q3W is 1 treatment cycle). The administered pembrolizumab dose will be 200 mg Q3W for both treatment groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
AVT32-DRL\_PB at a dose 200 mg administered intravenously every 3 weeks.
Keytruda at a dose 200 mg administered intravenously every 3 weeks.
Site number 07010
Kiev, Ukraine
RECRUITINGTo demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
AUC0-3w (Cycle 1)
Time frame: Cycle 1 (each cycle is 21 days)
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
AUCtau,ss (Cycle 6)
Time frame: Cycle 6 (each cycle is 21 days)
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