Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®
- Conditions
- Melanoma
- Interventions
- Drug: JPB898 (Induction and Maintenance)Drug: Opdivo-EU (Induction)Drug: Opdivo-US (Induction)Drug: Yervoy-EU (Induction)Drug: Opdivo-EU (Maintenance)
- Registration Number
- NCT06587451
- Lead Sponsor
- Sandoz
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 720
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JPB898 JPB898 (Induction and Maintenance) Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase. JPB898 Yervoy-EU (Induction) Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase. Opdivo-EU Opdivo-EU (Induction) Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase. Opdivo-EU Yervoy-EU (Induction) Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase. Opdivo-EU Opdivo-EU (Maintenance) Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase. Opdivo-US Opdivo-US (Induction) Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase. Opdivo-US Yervoy-EU (Induction) Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase. Opdivo-US Opdivo-EU (Maintenance) Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sandoz Investigational Site
🇨🇳Taoyuan City, Taiwan