drugset / Trial / NCT06587451
Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-12-19
- Primary completion
- 2026-01-23
- Completion
- 2026-01-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JPB898 | Unknown | — | Intravenous |
| Comparator | Nivolumab | Monoclonal antibody | — | Intravenous |
| Background | Ipilimumab | Monoclonal antibody | — | Intravenous |