Real World Pharmacokinetics of Immune Checkpoint Inhibitors

Not Applicable

Terminated

• Conditions: Cancer
• Interventions: Other: blood sampling

• Registration Number: NCT04833075
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Rationale: Real-world pharmacokinetic data from cancer patients treated with immune checkpoint inhibitors (ICIs) are sparse. Moreover, pharmacokinetic parameters may be associated with response to ICI treatment and may act as a predictive or early response biomarker.

Objective: To describe the real-world pharmacokinetics of ICIs in patients eligible for ICI treatment or already treated with ICIs.

Study design: A low-interventional cross-sectional pharmacokinetic study. Study population: Patients treated with ICIs. Intervention: A maximum of 13 blood samples (39 mL) will be derived from subjects on treatment. After discontinuation of ICI treatment, a maximum of 7 blood samples (21 mL) will be derived.

Main study parameters: Real- world pharmacokinetic parameters of ICIs: clearance, volume of distribution, serum exposure (serum concentration - time curve).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-06
• Study Start: 2021-09-15
• Status Verified: 2022-09
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Treatment with immune checkpoint inhibitors (atezolizumab (Tecentriq®), avelumab (Bavencio®), cemiplimab (Libtayo®), durvalumab (Imfinzi®), ipilimumab (Yervoy®), nivolumab (Opdivo®) and pembrolizumab (Keytruda®))
• Willingness and ability to provide written informed consent
• Age 18 years or older

Exclusion Criteria

n/a (real-world)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	blood sampling	additional blood sampling (single arm)

Primary Outcome Measures

Name	Time	Method
Real-world pharmacokinetic parameters --> volume of distribution	t=0 until t=12 months or end-of-treatment, whichever comes first (on-treatment) and t=0 until max. t=26 weeks (after discontinuation)(depends on ICI used)	volume of distribution
Real-world pharmacokinetic parameters --> clearance	t=0 until t=12 months or end-of-treatment, whichever comes first (on-treatment) and t=0 until max. t=26 weeks (after discontinuation)(depends on ICI used)	baseline clearance, change of clearance during treatment
Real-world pharmacokinetic parameters --> exposure	t=0 until t=12 months or end-of-treatment, whichever comes first (on-treatment) and t=0 until max. t=26 weeks (after discontinuation)(depends on ICI used)	serum exposure (serum concentration - time curve)

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands