Trials / Terminated
TerminatedNCT06587451
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JPB898 (Induction and Maintenance) | Induction and Maintenance: Intravenous (IV) |
| DRUG | Opdivo-EU (Induction) | Induction: Intravenous (IV) |
| DRUG | Opdivo-US (Induction) | Induction: Intravenous (IV) |
| DRUG | Yervoy-EU (Induction) | Induction: Intravenous (IV) |
| DRUG | Opdivo-EU (Maintenance) | Maintenance: Intravenous (IV) |
Timeline
- Start date
- 2024-12-19
- Primary completion
- 2026-01-23
- Completion
- 2026-01-23
- First posted
- 2024-09-19
- Last updated
- 2026-02-24
Locations
22 sites across 11 countries: Chile, Georgia, Greece, Italy, Lithuania, Malaysia, Philippines, Poland, Portugal, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06587451. Inclusion in this directory is not an endorsement.