Melanoma Clinical Trial

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

Summary

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.

View Full Description

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.

View Eligibility Criteria

Eligibility 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 RECIST (version 1.1).
Tumor tissue from the resected site of disease 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.

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

620

Study ID:

NCT06054555

Recruitment Status:

Recruiting

Sponsor:

Amgen

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 11 Locations for this study

See Locations Near You

Ft Wayne Med Oncology Hematology
Fort Wayne Indiana, 46804, United States
Oncology Hematology Associates
Springfield Missouri, 65807, United States
Dr. Everett Chalmers Hospital
Fredericton New Brunswick, E3B 5, Canada
LLC "Todua Clinic"
Tbilisi , 0112;, Georgia
ISR-GEO Med Res Clin Healthycore
Tbilisi , 0112, Georgia
JSC KE Nat Ctr of Exp and Clin Surg
Tbilisi , 0159, Georgia
Multprofil Clinic Consilium Medulla
Tbilisi , 0186, Georgia
National Cancer Institute
Vilnius , LT-08, Lithuania
Hospital Universitario Virgen De La Macarena
Sevilla Andalucía, 41009, Spain
H.U.V.Arrixaca
El Palmar Murcia, Región De, 30120, Spain
Hospital Regional Universitario de Malaga
Málaga , 29011, Spain
Hospital Jerez Puerta Del Sur
Sevilla , 41009, Spain
Consorcio Hospital General Universitario de Valencia
Valencia , 46014, Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

620

Study ID:

NCT06054555

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.