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

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Melanoma

Treatments: Drug: ABP 206; Drug: Nivolumab

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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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