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.
Participants (male/female) ≥18 years of age at the time of signing the ICF.
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment.
Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma
Have had a solid organ transplant or bone marrow (stem cell) transplant that used donor stem cells (allogenic).
Has received prior systemic anticancer therapy for melanoma including investigational agents.
Participants with a history of mucosal or uveal melanoma, even if diagnosis and treatment were completed >5 years ago.
Parallel
AVT32-DRL_PB
Biological/VaccineAVT32-DRL\_PB at a dose 200 mg administered intravenously every 3 weeks.
Keytruda
Biological/VaccineKeytruda at a dose 200 mg administered intravenously every 3 weeks.
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
AUC0-3w (Cycle 1)
To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)
AUCtau,ss (Cycle 6)
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Alvotech Swiss AG
Lead sponsor
Dr. Reddy's Laboratories Limited
Collaborator