A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06054555

Patient View

This study evaluates the efficacy, safety, and immunogenicity of ABP 206 versus Nivolumab in treatment-naïve subjects with unresectable or metastatic melanoma. Participants, aged 18+, with measurable disease and ECOG PS 0 or 1, will be randomized to receive either drug intravenously every 4 weeks for up to 24 months, with a total study duration of approximately 26 months.

Patient Parameters

Program Overview

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

Description

Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab).

All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment.

The total duration of study participation for each subject will be approximately 26 months.

Eligibility Criteria

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.

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