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
Overview
- Phase
- Phase 3
- Intervention
- JPB898 (Induction and Maintenance)
- Conditions
- Not specified
- Sponsor
- Sandoz
- Enrollment
- 52
- Locations
- 22
- Primary Endpoint
- Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU
- Status
- Terminated
- Last Updated
- 2 months ago
Overview
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.
Investigators
Biosimilar Clinical Trials Information Point
Scientific
H e x a l AG
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
- •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.
Arms & Interventions
JPB898
Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase.
Intervention: JPB898 (Induction and Maintenance)
JPB898
Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase.
Intervention: Yervoy-EU (Induction)
Opdivo-EU
Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
Intervention: Opdivo-EU (Induction)
Opdivo-EU
Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
Intervention: Yervoy-EU (Induction)
Opdivo-EU
Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
Intervention: Opdivo-EU (Maintenance)
Opdivo-US
Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
Intervention: Opdivo-US (Induction)
Opdivo-US
Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
Intervention: Yervoy-EU (Induction)
Opdivo-US
Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
Intervention: Opdivo-EU (Maintenance)
Outcomes
Primary Outcomes
Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU
Time Frame: 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
Time Frame: 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
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
Time Frame: 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