Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JPB898 (Induction and Maintenance) | Drug | — | UNRESOLVED |
| Opdivo-EU (Induction) | Drug | — | UNRESOLVED |
| Opdivo-EU (Maintenance) | Drug | — | UNRESOLVED |
| Opdivo-US (Induction) | Drug | — | UNRESOLVED |
| Yervoy-EU (Induction) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- JPB898
- description
- Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase.
- interventionNames
- Drug: JPB898 (Induction and Maintenance)
- Drug: Yervoy-EU (Induction)
- type
- ACTIVE_COMPARATOR
- label
- Opdivo-EU
- description
- Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
- interventionNames
- Drug: Opdivo-EU (Induction)
- Drug: Yervoy-EU (Induction)
- Drug: Opdivo-EU (Maintenance)
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available