Unique ID issued by UMIN | UMIN000033036 |
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Receipt number | R000037665 |
Scientific Title | Single-center study of CHeckpoint inhibitor Optimization based on PK/PD and ADA INvestigations in real-life clinical practice |
Date of disclosure of the study information | 2018/06/19 |
Last modified on | 2021/08/31 20:58:23 |
Single-center study of CHeckpoint inhibitor Optimization based on PK/PD and ADA INvestigations in real-life clinical practice
CHOPIN study
Single-center study of CHeckpoint inhibitor Optimization based on PK/PD and ADA INvestigations in real-life clinical practice
CHOPIN study
Japan |
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
Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
Endocrinology and Metabolism | Hematology and clinical oncology | Gastrointestinal surgery |
Breast surgery | Obstetrics and Gynecology | Dermatology |
Oto-rhino-laryngology | Orthopedics | Urology |
Malignancy
NO
We will reveal an association between exposure to immune checkpoint inhibitors and efficacy/safety in cancer patients. Furthermore, we will investigate the development of anti-drug antibody (ADA) to immune checkpoint inhibitors in real-life clinical practice, and its influence on pharmacokinetics and efficacy as well as infusion reactions associated with the immunogenicity will be clarified. In addition, we will also characterize the population pharmacokinetics of immune checkpoint inhibitors, and will identify factors affecting the interindividual variability for pharmacokinetic parameters. As an additional study, we will assess the accuracy of urine glucose self-test positivity against early detection of type 1 diabetes mellitus. Furthermore, we will examine the clinical relevance of soluble PD-L1 (sPD-L1) in blood of patients.
PK,PD
Exploratory
Not applicable
To reveal an association between exposure to immune checkpoint inhibitors and efficacy/safety in cancer patients.
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.
Observational
Not applicable |
Not applicable |
Male and Female
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
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
200
1st name | |
Middle name | |
Last name | Masahide Fukudo |
Asahikawa Medical University
Department of Hospital Pharmacy and Pharmacology
2-1-1-1 Midorigaokahigashi, Asahikawa 078-8510, Japan
0166-69-3482
mfukudo@asahikawa-med.ac.jp
1st name | |
Middle name | |
Last name | Masahide Fukudo |
Asahikawa Medical University
Department of Hospital Pharmacy and Pharmacology
2-1-1-1 Midorigaokahigashi, Asahikawa 078-8510, Japan
0166-69-3482
mfukudo@asahikawa-med.ac.jp
Department of Hospital Pharmacy and Pharmacology, Asahikawa Medical University
None
Self funding
NO
旭川医科大学病院(北海道)
2018 | Year | 06 | Month | 19 | Day |
Unpublished
Completed
2016 | Year | 06 | Month | 17 | Day |
2016 | Year | 06 | Month | 17 | Day |
2016 | Year | 08 | Month | 01 | Day |
2021 | Year | 08 | Month | 01 | Day |
Outcome measures to be studied:
1) Maximum serum drug concentrations (Cmax), serum trough drug concentrations (Ctrough), and longitudinal follow-up of drug concentrations after treatment discontinuations
2) Population pharmacokinetic parameters
3) Frequency of anti-drug antibody (screening and confirmatory assay)
4) Overall survival
5) Objective response rate
6) Frequency of immune-related adverse events (irAEs)
7) Frequency of infusion reactions
8) Frequency of type 1 diabetes mellitus
9) Frequency of urine glucose self-test positivity
10) Soluble PD-L1 (sPD-L1) in blood
2018 | Year | 06 | Month | 18 | Day |
2021 | Year | 08 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037665
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