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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
633
Objective response by Week 49
Time frame: Week 49
Objective response at Week 17
Time frame: Week 17
Progression-free survival (PFS)
Time frame: From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)
Overall survival (OS)
Time frame: From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Duration of response (DOR)
Time frame: From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Number of subjects with treatment-emergent adverse events
Time frame: Week 1 until Week 105
Number of subjects with treatment-emergent serious adverse events
Time frame: Week 1 until Week 105
Number of subjects with treatment-emergent adverse events of interest
Time frame: Week 1 until Week 105
Number of subjects with anti-drug antibodies
Time frame: 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)
Time frame: Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cancer and Blood Specialty clinic
Long Beach, California, United States
Fort Wayne Medical Oncology and Hematology - Office of Clinical Research
Fort Wayne, Indiana, United States
Our Lady of the Lake Physicians Group-Medical Oncology-Woman's Pavilion
Baton Rouge, Louisiana, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Hematology-Oncology Associates of Central New York, P.C. (HOA) - East Syracuse - CCOP
East Syracuse, New York, United States
Centro de Investigaciones Médicas y Desarrollo LC
Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina
Centro De Investigaciones Medicas Mar Del Plata (CIMMDP) - Rheumatology
Mar Del Plata, Río Negro Province, Argentina
Clínica Viedma - Oncology
Viedma, Río Negro Province, Argentina
Instituto De Oncologia De Rosario
Rosario, Santa Fe Province, Argentina
ISIS Clinica Especializada
Santa Fe, Argentina
...and 170 more locations