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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06054555
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Amgen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	MD
Principal Investigator Affiliation	Amgen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Bosnia and Herzegovina, Canada, Chile, Croatia, Czechia, Estonia, France, Georgia, Germany, Italy, Lithuania, Malaysia, Mexico, Philippines, Portugal, Romania, Serbia, Spain, Taiwan, Thailand, Turkey, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: ABP 206

Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.

Active Comparator: Nivolumab

Subjects will receive Dose A of Nivolumab via IV infusion.

Interventions

Drug: - ABP 206

ABP 206 will be given intravenously over a period of 30 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.

Drug: - Nivolumab

Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cancer and Blood Specialty Clinic, Long Beach, California

Status

Recruiting

Address

Cancer and Blood Specialty Clinic

Long Beach, California, 90806

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