Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of JPB898 (Proposed Nivolumab Biosimilar) and US-licensed and EU-authorized Opdivo® in Combination With Yervoy® in Participants With Untreated Advanced (Unresectable/Metastatic) Melanoma

The purpose of the study is to demonstrate similar PK and efficacy and to show comparable safety and immunogenicity between JPB898, Opdivo-EU, and Opdivo-US, all administered in combination with Yervoy-EU (induction phase only), in participants with advanced (unresectable Stage III or metastatic Stage IV) melanoma.

Inclusion Criteria

• Male or female participants must be 18 years or older.
• Histologically confirmed melanoma.
• Unresectable or metastatic melanoma measurable by Computerized tomography (CT) or Magnetic resonance imaging (MRI).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Known Programmed cell death ligand 1 (PD-L1) and BRAF mutational status or consent to testing.
• Sexually active participants must agree to use effective contraception.

Exclusion Criteria

• Active brain or leptomeningeal metastases unless stable for 8 weeks.
• Ocular melanoma.
• Prior active malignancy within the last year untreated or still requiring treatment.
• Severe and uncontrolled conditions, active Hepatitis B/C, Human immunodeficiency virus (HIV), or autoimmune diseases requiring systemic treatment.
• Previous treatment with specific immune checkpoint inhibitors, systemic anticancer therapy, or radiotherapy for melanoma.