Integrated PK/efficacy, safety, and immunogenicity study to demonstrate similarity of JPB898, a proposed biosimilar to nivolumab, to Opdivo® in combination with Yervoy®

Phase 3

Recruiting

• Conditions: Advanced (unresectable/metastatic) 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: 2023-507865-24-00
• Lead Sponsor: H e x a l AG

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

Study Timeline

• Study First Posted: 2024-07-17
• Last Update Posted: 2025-06-10

Recruitment & Eligibility

• Status: Authorised, recruiting
• Sex: Not specified
• Target Recruitment: 302

Inclusion Criteria

Not provided

Exclusion Criteria

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

Trial Locations

Locations (64)

Nacionalinis vezio institutas; 🇱🇹 Vilnius, Lithuania

Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos; 🇱🇹 Kaunas, Lithuania

Klaipedos universiteto ligonine VšĮ; 🇱🇹 Klaipeda, Lithuania

Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD; 🇧🇬 Sofia, Bulgaria

National Oncological Medical Center EOOD; 🇧🇬 Sofia, Bulgaria

Metropolitan Hospital; 🇬🇷 Pireas, Greece

Athens Medical Center S.A.; 🇬🇷 Thessaloniki, Greece

Fakultni Nemocnice Hradec Kralove; 🇨🇿 Novy Hradec Kralove, Czechia

Kožní ordinace; 🇨🇿 Praha 1, Czechia

Nemocnice AGEL Novy Jicin a.s.; 🇨🇿 Novy Jicin, Czechia

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Nacionalinis vezio institutas

🇱🇹Vilnius, Lithuania

Vincas Urbonas

Site contact

+37052190963

Vincas.Urbonas@nvi.lt