RECRUITING

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

Conditions

Melanoma Treatment-naive Unresectable melanoma Metastatic melanoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma

Quick Facts

Study Start:2023-11-02

Study Completion:2027-01-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06054555

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Amgen Call Center

CONTACT

1-800-772-6436

medinfo@amgen.com

Principal Investigator

STUDY_DIRECTOR

Amgen

Study Locations (Sites)

Cancer and Blood Specialty Clinic

Long Beach, California, 90806

United States

Ft Wayne Med Oncology Hematology

Fort Wayne, Indiana, 46804

United States

Our Lady of the Lake Physician Grp MO

Baton Rouge, Louisiana, 70805

United States

University of Maryland Medical Center-Greenebaum Cancer Ctr

Baltimore, Maryland, 21201

United States

Oncology Hematology Associates

Springfield, Missouri, 65807-5287

United States

Hematology-Oncology Associates-CNY

East Syracuse, New York, 13057

United States

Collaborators and Investigators

Sponsor: Amgen

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-02

Study Completion Date2027-01-25

Study Record Updates

Study Start Date2023-11-02

Study Completion Date2027-01-25

Terms related to this study

Keywords Provided by Researchers

Treatment-naive
Unresectable melanoma
Metastatic melanoma

Additional Relevant MeSH Terms

Melanoma