Comparing a new biosimilar treatment for advanced melanoma to existing therapies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sandoz Investigational Site
  Sofia, Bulgaria Recruiting
• Sandoz Investigational Site
  Providencia, Chile Recruiting
• Sandoz Investigational Site
  Santiago, Chile Recruiting
• Sandoz Investigational Site
  Vina del Mar, Chile Recruiting
• Sandoz Investigational Site
  Batumi, Georgia Recruiting
• Sandoz Investigational Site
  Tbilisi, Georgia Recruiting

Study contacts

• Study coordinator: Clinical Disclosure Representative
• Email: sandoz.disclosure@sandoz.net
• Phone: +49 8024 / 908 0

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.