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

Sponsored by Amgen

About this trial

Last updated 6 months ago

Study ID

20210031

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 99 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial 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.

What are the Participation Requirements?

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.