A Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytruda® as an Adjuvant Treatment in Participants with Stage IIB/C-III Melanoma Following Complete Resection

Stage IIB/C-III Melanoma

Area under the concentration-time curve from time 0 to 3 weeks (AUC0-3w) (Cycle 1), Area under the concentration-time curve over the dosing interval at steady-state (AUCtau) (Cycle 6)

PK: Maximum concentration after the first dose (Cmax,0-3w) (Cycle 1) and at steady-state (Cmax,tau) (Cycle 6), PK: Observed concentration before the next dose during multiple dosing cycles (Ctrough), PK: Time to maximum concentration after the first dose (Tmax,0-3w) (Cycle 1) and at steady-state (Tmax,tau) (Cycle 6), PK: Apparent clearance after the first dose (CL0-3w) (Cycle 1) and at steady-state (CLtau) (Cycle 6), PK: Terminal elimination half-life (t½) (Cycle 1 and Cycle 6), PK: Apparent volume of distribution after the first dose (Vz0-3w) (Cycle 1) and at steady-state (Vztau) (Cycle 6), Efficacy: Recurrence-free survival (RFS) assessed up to Week 51, Safety: Adverse events (AEs): incidence, nature (ie, description of the event), and severity including treatment-related AEs, serious adverse events, and adverse events of special interest, graded according to Common Terminology Criteria for Adverse Events grading, Safety: Absolute values and changes from baseline in: o Clinical laboratory assessments: hematology, biochemistry, and thyroid hormones o Vital signs o 12-lead electrocardiograms (ECGs) o Physical examination findings, Immunogenicity: Incidence and titer of anti-drug antibodies (ADAs) against AVT32-DRL_PB and Keytruda, Immunogenicity: Incidence of neutralizing antibodies (nAbs)

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