A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma

Study Overview
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Brief Summary
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The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.

Detailed Description
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Eligible subjects will be randomized in a 1:1:1 ratio to receive either ABP 206, Food and Drug Administration (FDA)-licensed nivolumab, or European Union (EU)-authorized nivolumab. The treatment period is in alignment with the maximum treatment duration for OPDIVO® (nivolumab, reference product) in the adjuvant setting for melanoma. All subjects will be treated until recurrence of disease, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1 year of treatment. The total duration of study participation for each subject will be approximately 13 months.

Official Title
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A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting

Conditions
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Melanoma

Intervention / Treatment
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* Drug: ABP 206
* Drug: FDA-licensed Nivolumab
* Drug: EU-authorized Nivolumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Completely removed melanoma by surgery performed within 12 weeks of randomization Advanced Melanoma Tumor tissue from the resected site of the disease must be available for biomarker analyses in order to be randomized Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: Previous anti-cancer treatment Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug Ocular or uveal melanoma or history of carcinomatosis meningitis History of auto-immune disease Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of the 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 minutes, every 4 weeks (Q4W) for a total of 12 months.<br>|
| Active Comparator: FDA-licensed Nivolumab<br>Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion. | Drug: FDA-licensed Nivolumab<br>* FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.<br>* Other names: OPDIVO®;|
| Active Comparator: EU-authorized Nivolumab<br>Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion. | Drug: EU-authorized Nivolumab<br>* FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.<br>* Other names: OPDIVO®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d) | The PK similarity (AUC0-28d) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting. | Day 1 (Postdose) through Day 28 | 
| Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS) | The PK similarity (AUCtau_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting. | Week 17 through Week 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1) | The PK similarity (Cmax_dose 1) of ABP 206 compared with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting. | Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) | 
| Maximum Observed Serum Concentration at Steady State (Cmax_ss) | The PK similarity (Cmax_ss) of ABP 206 compared with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting. | Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) | 
| Serum Concentrations at Predose (Ctrough) | The PK similarity (Ctrough) of ABP 206 compared with nivolumab determined in subjects with advanced melanoma in the adjuvant setting. | Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study) | 
| Number of Subjects With Treatment-Emergent Serious Adverse Events | The safety (treatment-emergent serious adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting. | Week 1 (First dose of study drug) through Week 53 (End of Study) | 
| Number of Subjects With Treatment-Emergent Adverse Events | The safety (treatment-emergent adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting. | Week 1 (First dose of study drug) through Week 53 (End of Study) | 
| Number of Subjects With Treatment-emergent Adverse Events-of-interest | The safety (treatment-emergent adverse events-of-interest) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in adjuvant setting. | Week 1 (First dose of study drug) through Week 53 (End of Study) | 
| Number of Subjects With Anti-drug Antibodies (ADAs) | The immunogenicity of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting. | Predose on Week 1 (Baseline), Weeks 5, 9, 17, 29, 41, and on Week 53 (End of Study) | 
| Recurrence-free Survival (RFS) | The RFS is assessed to compare the efficacy of ABP 206 with nivolumab in subjects with advanced melanoma in the adjuvant setting. The RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional, distant metastasis) or death (whatever the cause), or date of last visit/contact with disease assessments (for subjects who remain alive and whose disease has not recurred). | Randomization through 12 months (or until RFS criteria is met) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetic similarity study, Adjuvant melanoma treatment, Advanced Melanoma