Overview

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

Status:
SUSPENDED

Trial end date:
2026-02-01

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

Sandoz

Treatments:

Maintenance
Neoadjuvant Therapy