Melanoma
Conditions
Keywords
Treatment-naive, Unresectable melanoma, Metastatic melanoma
Brief summary
The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.
Detailed description
Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab). All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment. The total duration of study participation for each subject will be approximately 26 months.
Interventions
DRUGABP 206
ABP 206 will be given intravenously over a period of 30 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.
DRUGNivolumab
Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 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
Key Inclusion Criteria: * At least 18 years of age. * Histologically confirmed unresectable or metastatic melanoma. * Subject has no prior systemic treatment for advanced disease. * Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). * Tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Key
Exclusion criteria
* Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma. * Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug. * Subject has active central nervous system (CNS) metastases not previously treated. * Ocular melanoma. * Subject has active or known immune-mediated disorders. * Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways. * Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of response (DOR) | From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks) |
| Objective response by Week 49 | Week 49 |
| Objective response at Week 17 | Week 17 |
| Progression-free survival (PFS) | From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks) |
| Overall survival (OS) | From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with treatment-emergent adverse events | Week 1 until Week 105 |
| Number of subjects with treatment-emergent serious adverse events | Week 1 until Week 105 |
| Number of subjects with treatment-emergent adverse events of interest | Week 1 until Week 105 |
| Number of subjects with anti-drug antibodies | Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105 |
| Serum concentrations of ABP 206 and nivolumab (Ctrough) | Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105 |
Countries
Argentina, Bosnia and Herzegovina, Canada, Chile, Croatia, Czechia, Estonia, France, Georgia, Germany, Italy, Jordan, Lebanon, Lithuania, Malaysia, Mexico, Moldova, Netherlands, Philippines, Portugal, Romania, Serbia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States, Vietnam
Outcome results
None listed