Status:
SUSPENDED
Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®
Lead Sponsor:
Sandoz
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Yervo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT06587451
Start Date
December 19 2024
End Date
February 1 2026
Last Update
August 7 2025
Active Locations (57)
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1
Sandoz Investigational Site
Sofia, Bulgaria
2
Sandoz Investigational Site
Providencia, Chile
3
Sandoz Investigational Site
Santiago, Chile
4
Sandoz Investigational Site
Viña del Mar, Chile