A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma
Study Details
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.
Protocol Summary
Area Under the Serum Concentration-time Curve from Time Zero to 28 Days (AUC0-28d)
Timeframe: Day 1 (Postdose) through Day 28
Area Under the Serum Concentration-time Curve Over the Dosing Interval at Steady State (AUCtau_SS)
Timeframe: Week 17 through Week 21
Maximum Observed Serum Concentration Following the First Dose (Cmax_dose 1)
Timeframe: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Maximum Observed Serum Concentration at Steady State (Cmax_ss)
Timeframe: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Serum Concentrations at Predose (Ctrough)
Timeframe: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Number of Subjects With Treatment-Emergent Serious Adverse Events
Timeframe: Week 1 (First dose of study drug) through Week 53 (End of Study)
Number of Subjects With Treatment-Emergent Adverse Events
Timeframe: Week 1 (First dose of study drug) through Week 53 (End of Study)
Number of Subjects With Treatment-emergent Adverse Events-of-interest
Timeframe: Week 1 (First dose of study drug) through Week 53 (End of Study)
Number of Subjects With Anti-drug Antibodies (ADAs)
Timeframe: Predose on Week 1 (Baseline), Weeks 5, 9, 17, 21, 29, 41, and at Week 53 (End of Study)
Recurrence-free Survival (RFS)
Timeframe: Randomization through 12 months (or until RFS criteria is met)
Time to reach Cmax following the first dose (Tmax_dose 1)
Timeframe: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Time to reach Cmax at steady state (Tmax_ss)
Timeframe: Week 1 (Baseline) through Week 9, Week 17 to 29, Week 41, and Week 53 (End of Study)
Serum Concentrations (Ctrough)
Timeframe: At Week 5 (Pre-dose), and at Weeks 17 and 21 (Pre-dose)