Validation of Pharmacokinetic and Pharmacodynamic Assays for determination of Nivolumab and Pembrolizumab concentrations, and the occupancy of their target receptor Programmed Death-1 (PD-1) on T-cells

Validation of Pharmacokinetic and Pharmacodynamic Assays for determination of Nivolumab and Pembrolizumab concentrations, and the occupancy of their target receptor Programmed Death-1 (PD-1) on T-cells - Developing Assays for Anti-PD-1 monoclonal antibodies

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47401

Enrollment

Registered

2016-10-27

Start date

2017-06-22

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastasized cancer Solid tumors

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with solid tumors who will start treatment with nivolumab or pembrolizumab and are willing to undergo blood sampling and/or donate residual material.

Exclusion criteria

Exclusion criteria: Patients with known alcoholism, drug addiction, psychotic disorders in the history and/or other reasons, for which they are not amendable for adequate follow up. Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients.

Design outcomes

Primary

Measure	Time frame
Establish the clinical applicability as part of the validation of assays for the determination of free and PD-1 receptor bound anti-PD-1 monoclonal antibodies pembrolizumab and nivolumab in peripheral blood and other material.	—

Secondary

Measure	Time frame
Cross-validation between the described ELISAs and LC-MS methods.	—

Countries

Netherlands

Outcome results