The trial is taking place at:
O

Oncology Hematology Associates | Springfield, MO

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

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Amgen

Status and phase

Enrolling
Phase 3

Conditions

Melanoma

Treatments

Drug: Nivolumab
Drug: ABP 206

Study type

Interventional

Funder types

Industry

Identifiers

NCT06054555
20210031
2023-503288-40 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

620 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and 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 RECIST (version 1.1).
  • Tumor tissue from the resected site of disease 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

620 participants in 2 patient groups

ABP 206
Experimental group
Description:
Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
Treatment:
Drug: ABP 206
Nivolumab
Active Comparator group
Description:
Subjects will receive Dose A of Nivolumab via IV infusion.
Treatment:
Drug: Nivolumab

Trial contacts and locations

87

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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