Real World Pharmacokinetics of Immune Checkpoint Inhibitors

Cancer Clinical Trial

— ELICIT  

Official title:

Real World Pharmacokinetics of Immune Checkpoint Inhibitors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04833075
• Other study ID #: ELICIT
• Status: Terminated
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: September 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• blood sampling
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.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-world pharmacokinetic parameters --> clearance	baseline clearance, change of clearance during treatment	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)
Primary	Real-world pharmacokinetic parameters --> volume of distribution	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)
Primary	Real-world pharmacokinetic parameters --> exposure	serum exposure (serum concentration - time curve)	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)