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Completed

NCT Number: NCT05907122

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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology, Mar Del Plata, Río Negro Province, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABP 206

Drug

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

FDA-licensed Nivolumab

Drug

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

Other names: OPDIVO®

EU-authorized Nivolumab

Drug

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

Other names: OPDIVO®

Primary outcomes

  1. Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)

    Time frame: Day 1 (Postdose) through Day 28

    The PK similarity (AUC0-28d) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.

  2. Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS)

    Time frame: Week 17 through Week 21

    The PK similarity (AUCtau_ss) of ABP 206 compared with nivolumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.

Secondary outcomes

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

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

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

  2. Maximum Observed Serum Concentration at Steady State (Cmax_ss)

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

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

  3. Serum Concentrations at Predose (Ctrough)

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

    The PK similarity (Ctrough) of ABP 206 compared with nivolumab determined in subjects with advanced melanoma in the adjuvant setting.

  4. Number of Subjects With Treatment-Emergent Serious Adverse Events

    Time frame: Week 1 (First dose of study drug) through Week 53 (End of Study)

    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.

  5. Number of Subjects With Treatment-Emergent Adverse Events

    Time frame: Week 1 (First dose of study drug) through Week 53 (End of Study)

    The safety (treatment-emergent adverse events) of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.

  6. Number of Subjects With Treatment-emergent Adverse Events-of-interest

    Time frame: Week 1 (First dose of study drug) through Week 53 (End of Study)

    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.

  7. Number of Subjects With Anti-drug Antibodies (ADAs)

    Time frame: Predose on Week 1 (Baseline), Weeks 5, 9, 17, 21, 29, 41, and at Week 53 (End of Study)

    The immunogenicity of ABP 206 compared with nivolumab will be assessed in subjects with advanced melanoma in the adjuvant setting.

  8. Recurrence-free Survival (RFS)

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

    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).

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

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

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

  10. Time to reach Cmax at steady state (Tmax_ss)

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

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

  11. Serum Concentrations (Ctrough)

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

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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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