Study Comparing ABP 206 and OPDIVO® (Nivolumab) for Patients with Advanced Melanoma

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06054555

Provider View

This clinical trial is testing a new treatment, ABP 206, against the existing drug Nivolumab to see which is more effective and safe for patients with advanced melanoma that cannot be surgically removed or has spread to other parts of the body.

Patient Parameters

Program Overview

The study aims to compare the effectiveness, safety, and immune response of a new treatment, ABP 206, with Nivolumab in patients who have advanced melanoma that cannot be removed by surgery or has spread. Participants will be randomly assigned to receive either ABP 206 or Nivolumab and will continue treatment until their disease worsens, they experience unacceptable side effects, or they choose to stop, for up to 24 months. The entire study participation will last about 26 months for each patient.

Description

Participants in this study will be randomly assigned to receive either the new treatment, ABP 206, or the existing treatment, Nivolumab. The treatment will continue until the melanoma progresses, side effects become too severe, or the participant decides to stop, with a maximum treatment period of 24 months. The total time each participant will be involved in the study is approximately 26 months, including follow-up.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of melanoma that cannot be surgically removed or has spread.
  • Have not received any previous systemic treatment for advanced melanoma.
  • Have measurable cancer according to specific medical criteria.
  • Provide a tumor sample for biomarker analysis.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Have received any previous systemic anti-cancer therapy for advanced melanoma.
  • Have allergies to monoclonal antibodies or ingredients in the study drug.
  • Have active brain metastases that have not been treated.
  • Have ocular melanoma.
  • Have active or known immune system disorders.
  • Have previously been treated with certain immune checkpoint inhibitors.
  • Require systemic immunosuppressive medications within 14 days before starting the study treatment.

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