Systemic concentrations of avelumab and chemotherapies were measured in patient blood samples to estimate relevant pharmacokinetic parameters. Blood samples (3.5 mL) for avelumab pharmacokinetic analyses were collected prior to dosing and at the end of infusion on day 1 of cycles 1, 2, 3, 6, 10, and 14; additional samples were collected on day 15 of cycles 1, 2, and 3. Blood samples (3.5 mL) for avelumab immunogenicity analyses were collected prior to dosing on day 1 of cycles 1, 2, 3, 6, 10, and 14 and at the end of treatment.
Protocol detail
Avelumab Pharmacokinetics and Immunogenicity
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Corresponding Organization :
Other organizations : Royal Cornwall Hospital Trust, Marche Polytechnic University, Fundación Instituto Valenciano de Oncología, Kingston Health Sciences Centre, Newcastle University, The Kinghorn Cancer Centre, Sarah Cannon Research Institute, National Institute of Oncology, Hospital Clínic de Barcelona, Hospital Universitario 12 De Octubre, University of Sheffield, General University Hospital in Prague, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Pfizer (United States), Pfizer (France), Pfizer (Italy), Hospital Universitario Fundación Jiménez Díaz
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Variable analysis
independent variables
- Cycle number (1, 2, 3, 6, 10, 14)
- Systemic concentrations of avelumab
- Systemic concentrations of chemotherapies
- Avelumab immunogenicity
- Blood sample volume (3.5 mL)
- The independent variable is the cycle number, which is manipulated by the researchers.
- The dependent variables are the systemic concentrations of avelumab and chemotherapies, as well as avelumab immunogenicity, which are the measured outcomes.
- The control variable is the blood sample volume, which is kept constant at 3.5 mL to ensure valid results.
- No positive or negative controls are explicitly mentioned in the input.
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