Melanoma
Conditions
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 Yervoy-EU (induction phase only), in participants with advanced (unresectable Stage III or metastatic Stage IV) melanoma.
Interventions
DRUGJPB898 (Induction and Maintenance)
Induction and Maintenance: Intravenous (IV)
DRUGOpdivo-EU (Induction)
Induction: Intravenous (IV)
DRUGOpdivo-US (Induction)
Induction: Intravenous (IV)
DRUGYervoy-EU (Induction)
Induction: Intravenous (IV)
DRUGOpdivo-EU (Maintenance)
Maintenance: Intravenous (IV)
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate efficacy similarity for Best overall response (BOR) between JPB898 and Opdivo-US/-EU defined as the best overall response based on blinded central tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria | BOR (Complete response (CR) or partial response (PR)) from baseline up to 28 weeks | The assessment of response for the primary efficacy is based on tumor response data as per blinded independent central review and according to RECIST 1.1 |
| Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU | Days 1 to 22 | Area under the serum concentration-time curve measured from the time of dosing of the first dose to the second dose (AUCtrunc) after the first dose |
| Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU between JPB898 and Opdivo-US/-EU | Days 64 to 85 | Area under the serum concentration-time curve measured from the time of dosing to the last measurable serum concentration in the dosing interval, tau (AUCtau) after the fourth dose |
Countries
Chile, Georgia, Greece, Italy, Lithuania, Malaysia, Philippines, Poland, Portugal, South Korea, Spain
Outcome results
None listed