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Comparing ABP 206 to Nivolumab for treating advanced melanoma

A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma

PHASE3 · Amgen · NCT06054555

This study is testing whether a new treatment called ABP 206 works better than Nivolumab for people with advanced melanoma who haven't received treatment before.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment620 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorAmgen (industry)
Drugs / interventionsNivolumab
Locations179 sites (Long Beach, California and 178 other locations)
Trial IDNCT06054555 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy, safety, and immunogenicity of ABP 206 compared to Nivolumab in patients with treatment-naive unresectable or metastatic melanoma. Participants will be randomly assigned to receive either ABP 206 or Nivolumab, with treatment continuing until disease progression, unacceptable toxicity, or withdrawal of consent, for a maximum of 24 months. The total duration of participation for each subject is expected to be around 26 months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed unresectable or metastatic melanoma who have not received prior systemic treatment.

Not a fit: Patients with prior systemic anti-cancer therapy for advanced melanoma or those with active central nervous system metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced melanoma.

How similar studies have performed: Other studies have shown success with similar immunotherapy approaches, indicating potential for positive outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* At least 18 years of age.
* Histologically confirmed unresectable or metastatic melanoma.
* Subject has no prior systemic treatment for advanced disease.
* Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
* Tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Key Exclusion Criteria:

* Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma.
* Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug.
* Subject has active central nervous system (CNS) metastases not previously treated.
* Ocular melanoma.
* Subject has active or known immune-mediated disorders.
* Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways.
* Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product.

Other protocol-defined inclusion/exclusion criteria apply.

Where this trial is running

Long Beach, California and 178 other locations

+129 more sites — see ClinicalTrials.gov for the full list.

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 →

Conditions: Melanoma, Treatment-naive, Unresectable melanoma, Metastatic melanoma

Last reviewed 2026-05-15 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.