A Study to Evaluate ABP 206 Compared with OPDIVO® (Nivolumab) in Subjects with Unresectable or Metastatic Melanoma
Study Details
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.
Protocol Summary
Objective response by Week 49
Timeframe: Week 49
Objective response at Week 17
Timeframe: Week 17
Progression-free survival (PFS)
Timeframe: From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks)
Overall survival (OS)
Timeframe: From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Duration of response (DOR)
Timeframe: From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks)
Number of subjects with treatment-emergent adverse events
Timeframe: Week 1 until Week 105
Number of subjects with treatment-emergent serious adverse events
Timeframe: Week 1 until Week 105
Number of subjects with treatment-emergent adverse events of interest
Timeframe: Week 1 until Week 105
Number of subjects with anti-drug antibodies
Timeframe: 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)
Timeframe: Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105