A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
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.
Condition
- Melanoma
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
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 Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- The study is double-blinded; therefore, the investigators, study personnel (with the exception of the data monitoring committee, authorized unblinded sponsor and contract research organization staff, and unblinded site pharmacy staff) and the study subjects will remain blinded to treatment allocation. ABP 206 and nivolumab will be coded and labeled to protect blinding.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Cancer and Blood Specialty clinic
Long Beach, California 90806
Long Beach, California 90806
Our Lady of the Lake Physician Grp MO
Baton Rouge, Louisiana 70805
Baton Rouge, Louisiana 70805
University of Maryland Medical Center-Greenebaum Cancer Ctr
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Oncology Hematology Associates
Springfield, Missouri 65807-5287
Springfield, Missouri 65807-5287
Hematology-Oncology Associates-CNY
East Syracuse, New York 13057
East Syracuse, New York 13057
More Details
- NCT ID
- NCT06054555
- Status
- Recruiting
- Sponsor
- Amgen
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 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.