Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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

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

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

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

ABP 206

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

FDA-licensed Nivolumab

EU-authorized Nivolumab

Amgen Call Center

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.

The study is double-blinded; therefore, the investigators, study personnel (with the exception of the data monitoring committee, authorized unblinded sponsor and contract research organization staff, and unblinded site pharmacy staff), and the study subjects will remain blinded to treatment allocation. ABP 206 and nivolumab will be coded and labeled to protect blinding.

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

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

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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

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

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

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

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

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.

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

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.

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

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).

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

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

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

Spots Global Cancer Trial Database for abp 206

Every month we try and update this database with for abp 206 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for abp 206

Every month we try and update this database with for abp 206 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for abp 206 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.