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

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.