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

Sponsor
Sandoz
Study ID
NCT06587451
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JPB898 (Induction and Maintenance) — DRUG
    Induction and Maintenance: Intravenous (IV)
  • Opdivo-EU (Induction) — DRUG
    Induction: Intravenous (IV)
  • Opdivo-US (Induction) — DRUG
    Induction: Intravenous (IV)
  • Yervoy-EU (Induction) — DRUG
    Induction: Intravenous (IV)
  • Opdivo-EU (Maintenance) — DRUG
    Maintenance: Intravenous (IV)

Study Details

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.

Key Dates

Start date
Dec 19, 2024
Status verified
Feb 2026
Primary completion
Jan 23, 2026
Completion
Jan 23, 2026

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JPB898
    Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase.
  • Active Comparator: Opdivo-EU
    Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
  • Active Comparator: Opdivo-US
    Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.

Primary Outcome Measure

Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU [ Time Frame: Days 1 to 22 ]

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