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

Amgen256 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

256

Conditions

Melanoma

Interventions

ABP 206DRUG

ABP 206 will be given intravenously over a period of 30 minutes, every 4 weeks (Q4W) for a total of 12 months.

FDA-licensed NivolumabDRUG

FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.

EU-authorized NivolumabDRUG

FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (76)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Week 17 through Week 21

Secondary Outcomes

Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1)

The comparison of PK (Cmax\_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.

Time frame: 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 comparison of PK (Cmax\_ss) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Cancer and Blood Specialty clinic

Long Beach, California, United States

St. Vincent Frontier Cancer Center - Oncology

Billings, Montana, United States

Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology

Mar Del Plata, Río Negro Province, Argentina

Clinical Center University of Sarajevo - Clinic of Oncology

Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina

University Clinical Centre of the Republic of Srpska - Gastroenterology

Banja Luka, Republika Srpska, Bosnia and Herzegovina

University Clinical Center Tuzla - Oncology, Hematology and Radio

Tuzla, Tuzlanski Kanton, Bosnia and Herzegovina

Cantonal hospital Zenica - Oncology

Zenica, Zeničko-dobojski Kanton, Bosnia and Herzegovina

University Clinical Hospital Mostar - Clinic for Lung Diseases

Mostar, Bosnia and Herzegovina

ATO Oncologia

Fortaleza, Ceará, Brazil

Hospital Sao Rafael

Salvador, Estado de Bahia, Brazil

...and 66 more locations

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Predose on Week 1 (Baseline), Weeks 5, 9, 17, 21, 29, 41, and at 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).

Time frame: Randomization through 12 months (or until RFS criteria is met)

Time to reach Cmax following the first dose (Tmax_dose 1)

The comparison of PK (Tmax\_dose 1) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.

Time frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)

Time to reach Cmax at steady state (Tmax_ss)

The comparison of PK (Tmax\_SS) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.

Time frame: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)

Serum Concentrations (Ctrough)

The comparison of PK (Ctrough) of ABP 206 with nivolumab will be determined in subjects with advanced melanoma in the adjuvant setting.

Time frame: At Week 5 (Pre-dose), and at Weeks 17 and 21 (Pre-dose)