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

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.

Conditions

Melanoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Melanoma
Intervention / Treatment

-

Contacts and Locations

Long Beach

Cancer and Blood Specialty Clinic, Long Beach, California, United States, 90806

Fort Wayne

Ft Wayne Med Oncology Hematology, Fort Wayne, Indiana, United States, 46804

Baton Rouge

Our Lady of the Lake Physician Grp MO, Baton Rouge, Louisiana, United States, 70805

Baltimore

University of Maryland Medical Center-Greenebaum Cancer Ctr, Baltimore, Maryland, United States, 21201

Springfield

Oncology Hematology Associates, Springfield, Missouri, United States, 65807-5287

East Syracuse

Hematology-Oncology Associates-CNY, East Syracuse, New York, United States, 13057

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2027-01-25