Recruitment Complete
Sponsor ID
20230127
Pharmacokinetic Similarity Between ABP 234 and Keytruda® (pembrolizumab)Eucalyptus
Study Details
The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.
Protocol Summary
Primary Outcome Measures
Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose
Timeframe: 21 days
AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss)
Timeframe: Weeks 16-19
Secondary Outcome Measures
Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1)
Timeframe: Up to 65 weeks
Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1)
Timeframe: Up to 65 weeks
Cmax at Steady State (Cmax_ss)
Timeframe: Weeks 16-19
Tmax at Steady State (Tmax_ss)
Timeframe: Weeks 16-19
Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4)
Timeframe: Week 4 pre-dose
Ctrough at Stead State (Ctrough_ss)
Timeframe: Weeks 16 and 19 pre-dose
Number of Participants with Treatment-emergent Adverse Events
Timeframe: Up to 16 months
Number of Participants with Treatment-emergent Serious Adverse Events
Timeframe: Up to 16 months
Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs)
Timeframe: Up to 16 months
Number of Participants with Andit-drug Antibodies
Timeframe: Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65
Disease-free Survival
Timeframe: Up to 65 weeks
Locations
Location
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia, Bulgaria, 1797
Status
Recruiting
Location
Centro de Investigaciones Clinicas Vina del Mar Ltda.
Viña del Mar, Region de Valparaiso, Chile, 2540364
Status
Recruiting
Location
CDIEM - Centro de Investigacion y Especialidades Medicas
Providencia, Region Metropolotana, Chile, 7500859
Status
Recruiting
Location
Azienda Ospedaliera Santa Maria Terni
Terni, Italy, 05100
Status
Recruiting
Location
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemysl, Poland, 37-700
Status
Completed
Location
Clincial Centre of Serbia
Belgrade, Serbia, 11000
Status
Recruiting
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