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

Amgen logo

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

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

Trial contacts and locations

106

Loading...

Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems