A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05907122

Patient View

This study assesses the PK similarity, efficacy, safety, and immunogenicity of ABP 206 versus FDA and EU-authorized nivolumab in resected advanced melanoma. Participants, aged 18+, with ECOG 0-1 and no prior anti-cancer treatment, will receive intravenous treatment every 4 weeks for up to 12 months. Exclusions include autoimmune disease and need for systemic immunosuppression.

Patient Parameters

Program Overview

The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.

Description

Eligible subjects will be randomized in a 1:1:1 ratio to receive either ABP 206, Food and Drug Administration (FDA)-licensed nivolumab, or European Union (EU)-authorized nivolumab.

The treatment period is in alignment with the maximum treatment duration for OPDIVO® (nivolumab, reference product) in the adjuvant setting for melanoma.

All subjects will be treated until recurrence of disease, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1 year of treatment.

The total duration of study participation for each subject will be approximately 13 months.

Eligibility Criteria

Inclusion Criteria

  • At least 18 years of age
  • Completely removed melanoma by surgery performed within 12 weeks of randomization
  • Advanced Melanoma
  • Tumor tissue from the resected site of the disease must be available for biomarker analyses in order to be randomized
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria

  • Previous anti-cancer treatment
  • Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug
  • Ocular or uveal melanoma or history of carcinomatosis meningitis
  • History of auto-immune disease
  • Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the investigational product

Other protocol-defined inclusion/exclusion criteria apply

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