Melanoma
Conditions
Keywords
Pharmacokinetic similarity study, Adjuvant melanoma treatment, Advanced Melanoma
Brief summary
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.
Detailed 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.
Interventions
DRUGABP 206
ABP 206 will be given intravenously over a period of 30 minutes, every 4 weeks (Q4W) for a total of 12 months.
DRUGFDA-licensed Nivolumab
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
DRUGEU-authorized Nivolumab
FDA-licensed Nivolumab will be given intravenously over a period of 30 minutes, Q4W for a total of 12 months.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d) | 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. |
| Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1) | 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. |
| Maximum Observed Serum Concentration at Steady State (Cmax_ss) | 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. |
| Serum Concentrations at Predose (Ctrough) | 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. |
| Number of Subjects With Treatment-Emergent Serious Adverse Events | 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. |
| Number of Subjects With Treatment-Emergent Adverse Events | 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. |
| Number of Subjects With Treatment-emergent Adverse Events-of-interest | 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. |
| Number of Subjects With Anti-drug Antibodies (ADAs) | 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. |
| Recurrence-free Survival (RFS) | 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). |
| Time to reach Cmax following the first dose (Tmax_dose 1) | 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. |
| Time to reach Cmax at steady state (Tmax_ss) | 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. |
| Serum Concentrations (Ctrough) | 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. |
Countries
Argentina, Bosnia and Herzegovina, Brazil, Chile, Croatia, Georgia, Italy, Japan, Lithuania, Malaysia, Mexico, Moldova, Netherlands, Romania, Serbia, South Africa, South Korea, Spain, Taiwan, Thailand, United States, Vietnam
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed