Single-center study of CHeckpoint inhibitor Optimization based on PK/PD and ADA INvestigations in real-life clinical practice

Single-center study of CHeckpoint inhibitor Optimization based on PK/PD and ADA INvestigations in real-life clinical practice - CHOPIN study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033036

Enrollment

200

Registered

2018-06-19

Start date

2016-08-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

1) Malignant melanoma 2) Non-small cell lung cancer 3) Renal cell carcinoma 4) Classical hodgkin lymphoma 5) Squamous cell carcinoma of the head and neck 6) Gastric cancer 7) Urothelial carcinoma 8) Malignant pleural mesothelioma 9) Microsatellite instability-high cancer 10) Extensive-stage small cell lung cancer 11) Triple-negative breast cancer with PD-L1 expression 12) Microsatellite instability-high metastatic colorectal cancer 13) Esophageal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) All patients treated with the PD-1 blocker nivolumab or pembrolizumab 2) All patients treated with the CTLA-4 blocker ipilimumab 3) All patients treated with the PD-L1 blocker atezolizuma, durvalumab, or avelumab 4) Patients who can give written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients who are currently participating in or will be enrolled in clinical trials 2) Patients treated with immune checkpoint inhibitors as an off-label use

Design outcomes

Primary

Measure	Time frame
To reveal an association between exposure to immune checkpoint inhibitors and efficacy/safety in cancer patients.	—

Secondary

Measure	Time frame
1) To investigate the development of anti-drug antibody (ADA) to immune checkpoint inhibitors in real-life clinical practice, and to examine its influence on pharmacokinetics and efficacy as well as infusion reactions associated with the immunogenicity. 2) To characterize the population pharmacokinetics of immune checkpoint inhibitors, and to identify factors affecting the interindividual variability for pharmacokinetic parameters. 3) To assess the accuracy of urine glucose self-test positivity against early detection of type 1 diabetes mellitus. 4) To examine the clinical relevance of soluble PD-L1 (sPD-L1) in blood of patients.	—

Measure

Time frame

1) To investigate the development of anti-drug antibody (ADA) to immune checkpoint inhibitors in real-life clinical practice, and to examine its influence on pharmacokinetics and efficacy as well as infusion reactions associated with the immunogenicity. 2) To characterize the population pharmacokinetics of immune checkpoint inhibitors, and to identify factors affecting the interindividual variability for pharmacokinetic parameters. 3) To assess the accuracy of urine glucose self-test positivity against early detection of type 1 diabetes mellitus. 4) To examine the clinical relevance of soluble PD-L1 (sPD-L1) in blood of patients.

—

Countries

Japan

Contacts

Public ContactMasahide Fukudo

Asahikawa Medical University Department of Hospital Pharmacy and Pharmacology

mfukudo@asahikawa-med.ac.jp0166-69-3482

Outcome results