The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
163
Administered by intravenous (IV) injection.
Administered by IV injection.
Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose
Time frame: 21 days
AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss)
Time frame: Weeks 16-19
Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1)
Time frame: Up to 65 weeks
Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1)
Time frame: Up to 65 weeks
Cmax at Steady State (Cmax_ss)
Time frame: Weeks 16-19
Tmax at Steady State (Tmax_ss)
Time frame: Weeks 16-19
Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4)
Time frame: Week 4 pre-dose
Ctrough at Stead State (Ctrough_ss)
Time frame: Weeks 16 and 19 pre-dose
Number of Participants with Treatment-emergent Adverse Events
Time frame: Up to 16 months
Number of Participants with Treatment-emergent Serious Adverse Events
Time frame: Up to 16 months
Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs)
Time frame: Up to 16 months
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Fundacion ARS Medica
San Salvador de Jujuy, Jujuy Province, Argentina
Instituto de Oncologia de Rosario
Rosario, Santa Fe Province, Argentina
Ionc Instituto Oncologico De Cordoba
Córdoba, Argentina
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia, Bulgaria
CDIEM - Centro de Investigacion y Especialidades Medicas
Providencia, Region Metropolotana, Chile
Instituto Oncologico Fundacion Arturo Lopez Perez (FALP)
Providencia, Santiago Metropolitan, Chile
Centro de Oncologia de Precision
Region Metropolitana, Santiago Metropolitan, Chile
Clinica Santa Maria
Santiago, Santiago Metropolitan, Chile
Centro de Investigaciones Clinicas Vina del Mar Ltda.
Viña Del Mar, Valparaiso, Chile
Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI
Viña del Mar, Valparaiso, Chile
...and 118 more locations
Number of Participants with Andit-drug Antibodies
Time frame: Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65
Disease-free Survival
Time frame: Up to 65 weeks