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Real World Pharmacokinetics of Immune Checkpoint Inhibitors (ELICIT)

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ClinicalTrials.gov Identifier: NCT04833075
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
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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).


Condition or disease Intervention/treatment Phase
Cancer Other: blood sampling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A low-interventional cross-sectional pharmacokinetic study.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Real World Pharmacokinetics of Immune Checkpoint Inhibitors
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : September 15, 2024
Estimated Study Completion Date : September 15, 2024
Arms and Interventions
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Arm Intervention/treatment
Single arm
additional blood sampling (single arm)
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Real-world pharmacokinetic parameters --> clearance [ Time Frame: 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

  2. Real-world pharmacokinetic parameters --> volume of distribution [ Time Frame: 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

  3. Real-world pharmacokinetic parameters --> exposure [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833075


Contacts
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Contact: Leila S Otten, PharmD +31 6 29501773 Leila-Sophie.Otten@radboudumc.nl
Contact: Rob ter Heine, PhD +31-24-36 17744 r.terheine@radboudumc.nl

Locations
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Netherlands
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Leila Otten, PharmD       leila-sophie.otten@radboudumc.nl   
Contact: Rob ter Heine, PhD       R.terHeine@radboudumc.nl   
Sponsors and Collaborators
Radboud University Medical Center
More Information
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT04833075    
Other Study ID Numbers: ELICIT
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Radboud University Medical Center:
Immune Checkpoint Inhibitor
Pharmacokinetics