MedTrace Logo

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

NCT06587451 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-02-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

JPB898 (Induction and Maintenance)

Induction and Maintenance: Intravenous (IV)

DRUG

Opdivo-EU (Induction)

Induction: Intravenous (IV)

DRUG

Opdivo-US (Induction)

Induction: Intravenous (IV)

DRUG

Yervoy-EU (Induction)

Induction: Intravenous (IV)

DRUG

Opdivo-EU (Maintenance)

Maintenance: Intravenous (IV)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2026-01-23
Completion
2026-01-23
FDA Drug
Yes

Countries

  • Chile
  • Georgia
  • Greece
  • Italy
  • Lithuania
  • Malaysia
  • Philippines
  • Poland
  • Portugal
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06587451 on ClinicalTrials.gov