In light of the evolving regulatory landscape and growing indications that major Health Authorities will move towards a streamlined clinical development, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.

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.