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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Melanoma

Intervention / Treatment
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* Drug: ABP 206
* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABP 206<br>Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion. | Drug: ABP 206<br>* ABP 206 will be given intravenously over a period of 30 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.<br>|
| Active Comparator: Nivolumab<br>Subjects will receive Dose A of Nivolumab via IV infusion. | Drug: Nivolumab<br>* Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.<br>* Other names: OPDIVO®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response by Week 49 |  | Week 49 | 
| Objective response at Week 17 |  | Week 17 | 
| Progression-free survival (PFS) |  | From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks) | 
| Overall survival (OS) |  | From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks) | 
| Duration of response (DOR) |  | From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with treatment-emergent adverse events |  | Week 1 until Week 105 | 
| Number of subjects with treatment-emergent serious adverse events |  | Week 1 until Week 105 | 
| Number of subjects with treatment-emergent adverse events of interest |  | Week 1 until Week 105 | 
| Number of subjects with anti-drug antibodies |  | Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105 | 
| Serum concentrations of ABP 206 and nivolumab (trough) |  | Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment-naive, Unresectable melanoma, Metastatic melanoma