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

Sandoz

Status and phase: Enrolling; Phase 3

Conditions: Melanoma

Treatments: Drug: JPB898 (Induction and Maintenance); Drug: Opdivo-EU (Maintenance); Drug: Opdivo-US (Induction); Drug: Yervoy-EU (Induction); Drug: Opdivo-EU (Induction)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06587451

CJPB898A12301

Details and patient eligibility

About

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.

Enrollment: 720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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720 participants in 3 patient groups

JPB898

Experimental group

Description:

Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase.

Treatment:

Drug: Yervoy-EU (Induction)

Drug: JPB898 (Induction and Maintenance)

Opdivo-EU

Active Comparator group

Description:

Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.

Treatment:

Drug: Yervoy-EU (Induction)

Drug: Opdivo-EU (Induction)

Drug: Opdivo-EU (Maintenance)

Opdivo-US

Active Comparator group

Description:

Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.

Treatment:

Drug: Yervoy-EU (Induction)

Drug: Opdivo-US (Induction)

Drug: Opdivo-EU (Maintenance)