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Trial Title:
Integrated Pharmacokinetics (PK)/efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination with Yervoy®
NCT ID:
NCT06587451
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Nivolumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
JPB898 (Induction and Maintenance)
Description:
Induction and Maintenance: Intravenous (IV)
Arm group label:
JPB898
Intervention type:
Drug
Intervention name:
Opdivo-EU (Induction)
Description:
Induction: Intravenous (IV)
Arm group label:
Opdivo-EU
Intervention type:
Drug
Intervention name:
Opdivo-US (Induction)
Description:
Induction: Intravenous (IV)
Arm group label:
Opdivo-US
Intervention type:
Drug
Intervention name:
Yervoy-EU (Induction)
Description:
Induction: Intravenous (IV)
Arm group label:
JPB898
Arm group label:
Opdivo-EU
Arm group label:
Opdivo-US
Intervention type:
Drug
Intervention name:
Opdivo-EU (Maintenance)
Description:
Maintenance: Intravenous (IV)
Arm group label:
Opdivo-EU
Arm group label:
Opdivo-US
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 1, 2025
Completion date:
July 31, 2027
Lead sponsor:
Agency:
Sandoz
Agency class:
Industry
Source:
Sandoz
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06587451
