Real World Pharmacokinetics of Immune Checkpoint Inhibitors

NCT04833075 | Terminated DMC

• 1 other identifier: ELICIT
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer

Keywords

Immune Checkpoint Inhibitor; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

Single arm

OTHER

additional blood sampling (single arm)

Other: blood sampling

Interventions

blood sampling OTHER

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.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A low-interventional cross-sectional pharmacokinetic study.

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 6, 2021
• Study Start: September 15, 2021
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: May 31, 2023

Record last verified: 2022-09

Locations

NL (1)