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Comparing a new biosimilar treatment for advanced melanoma to existing therapies

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

Phase 3 Interventional Sandoz · NCT06587451

This study is testing a new treatment for advanced melanoma to see if it works as well and is as safe as current therapies.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment720 (estimated)
Ages18 Years and up
SexAll
SponsorSandoz Industry-sponsored
Locations46 sites (Sofia and 45 other locations)
Trial IDNCT06587451 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the pharmacokinetics, efficacy, safety, and immunogenicity of JPB898, a proposed biosimilar to Nivolumab, when used in combination with Yervoy in patients with advanced melanoma. Participants will receive either JPB898 or Opdivo (both EU and US formulations) alongside Yervoy during the induction phase. The study will assess whether JPB898 is similar in performance and safety to the established treatments. It is a Phase 3 interventional trial involving patients with unresectable or metastatic melanoma.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed unresectable or metastatic melanoma.

Not a fit: Patients with active brain metastases, ocular melanoma, or those who have received specific prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective alternative treatment option for patients with advanced melanoma.

How similar studies have performed: Other studies have shown success with similar biosimilar approaches, indicating potential for this treatment to be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Sofia and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Melanoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.