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

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Melanoma

Treatments: Drug: EU-authorized Nivolumab; Drug: ABP 206; Drug: FDA-licensed Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05907122

20220083

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 249 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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249 participants in 3 patient groups

ABP 206

Experimental group

Description:

Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.

Treatment:

Drug: ABP 206

FDA-licensed Nivolumab

Active Comparator group

Description:

Subjects will receive Dose A of FDA-licensed Nivolumab via IV infusion.

Treatment:

Drug: FDA-licensed Nivolumab

EU-authorized Nivolumab

Active Comparator group

Description:

Subjects will receive Dose A of EU-authorized Nivolumab via IV infusion.

Treatment:

Drug: EU-authorized Nivolumab