Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma

Required: PD-L1 (CD274) positive (≥1% to <5% or ≥5%) (≥1% to <5% or ≥5%)

All samples must be classified as PD-L1 positive (≥1% to <5% or ≥5%)

Allowed: BRAF any status

Any BRAF mutation status is allowed (BRAF-mutated, BRAF wild-type or non-mutated, or BRAF status unknown)

Cannot have received: systemic therapy

Exception: for advanced, unresectable, or metastatic Stage III or Stage IV melanoma (except for palliative radiotherapy, in accordance with Inclusion Criteria #9)

Subjects receiving any prior systemic therapy for advanced, unresectable, or metastatic Stage III or Stage IV melanoma (except for palliative radiotherapy, in accordance with Inclusion Criteria #9)

Cannot have received: immunotherapy (anti-PD-1 therapy, anti-PD-L1 therapy, anti-PD-L2 therapy, anti-CD137 therapy, anti-LAG therapy, anti-CTLA-4 therapy, ipilimumab, any other antibody or drug that specifically targets costimulation of T-cells or immune checkpoints)

Subjects receiving any prior immunotherapy (regardless of the melanoma stage), such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-LAG or anti-CTLA-4 therapy (including ipilimumab or any other antibody or drug that specifically targets costimulation of T-cells or immune checkpoints)

Cannot have received: BRAF-targeted therapy

and/or BRAF-targeted therapy