Status:
RECRUITING
A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
Lead Sponsor:
Amgen
Conditions:
Melanoma
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief 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.
Detailed 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 withdra...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 25 2028
Estimated Enrollment :
620 Patients enrolled
Trial Details
Trial ID
NCT06054555
Start Date
November 2 2023
End Date
January 25 2028
Last Update
January 5 2026
Active Locations (179)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer and Blood Specialty clinic
Long Beach, California, United States, 90806
2
Fort Wayne Medical Oncology and Hematology - Office of Clinical Research
Fort Wayne, Indiana, United States, 46825
3
Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion
Baton Rouge, Louisiana, United States, 70809
4
Oncology Hematology Associates
Springfield, Missouri, United States, 65807-5287