Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®

February 23, 2026 updated by: Sandoz

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Sandoz Investigational Site
      • Santiago, Chile
        • Sandoz Investigational Site 1
  • Georgia
      • Tbilisi, Georgia
        • Sandoz Investigational Site 2
  • Greece
      • Athens, Greece
        • Sandoz Investigational Site
      • Thessaloniki, Greece
        • Sandoz Investigational Site
  • Italy
      • Pisa, Italy
        • Sandoz Investigational Site
  • Lithuania
      • Vilnius, Lithuania
        • Sandoz Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Sandoz Investigational Site
      • Pulau Pinang, Malaysia
        • Sandoz Investigational Site
      • Putrajaya, Malaysia
        • Sandoz Investigational Site
  • Philippines
      • Bacolod, Philippines
        • Sandoz Investigational Site
  • Poland
      • Warsaw, Poland
        • Sandoz Investigational Site
  • Portugal
      • Lisbon, Portugal
        • Sandoz Investigational Site
  • South Korea
      • Busan, South Korea
        • Sandoz Investigational Site 1
      • Daejeon, South Korea
        • Sandoz Investigational Site
      • Seoul, South Korea
        • Sandoz Investigational Site 2
  • Spain
      • Madrid, Spain
        • Sandoz Investigational Site 2
      • Málaga, Spain
        • Sandoz Investigational Site
      • Oviedo, Spain
        • Sandoz Investigational Site
      • Santander, Spain
        • Sandoz Investigational Site
      • Santiago de Compostela, Spain
        • Sandoz Investigational Site
      • Valencia, Spain
        • Sandoz Investigational Site 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JPB898
Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase.
Drug: JPB898 (Induction and Maintenance)
Induction and Maintenance: Intravenous (IV)
Drug: Yervoy-EU (Induction)
Induction: Intravenous (IV)
Active Comparator: Opdivo-EU
Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
Drug: Yervoy-EU (Induction)
Induction: Intravenous (IV)
Drug: Opdivo-EU (Induction)
Induction: Intravenous (IV)
Drug: Opdivo-EU (Maintenance)
Maintenance: Intravenous (IV)
Active Comparator: Opdivo-US
Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.
Drug: Yervoy-EU (Induction)
Induction: Intravenous (IV)
Drug: Opdivo-EU (Maintenance)
Maintenance: Intravenous (IV)
Drug: Opdivo-US (Induction)
Induction: Intravenous (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Days 1 to 22
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
Days 64 to 85
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
BOR (Complete response (CR) or partial response (PR)) from baseline up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2024

Primary Completion (Actual)

January 23, 2026

Study Completion (Actual)

January 23, 2026

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJPB898A12301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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