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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033036
Receipt No. 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 2018/12/27

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Basic information
Public title Single-center study of CHeckpoint inhibitor Optimization based on PK/PD and ADA INvestigations in real-life clinical practice
Acronym CHOPIN study
Scientific Title Single-center study of CHeckpoint inhibitor Optimization based on PK/PD and ADA INvestigations in real-life clinical practice
Scientific Title:Acronym CHOPIN study
Region
Japan

Condition
Condition 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
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Endocrinology and Metabolism Hematology and clinical oncology Gastrointestinal surgery
Obsterics and gynecology Dermatology Oto-rhino-laryngology
Orthopedics Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To reveal an association between exposure to immune checkpoint inhibitors and efficacy/safety in cancer patients.
Key secondary outcomes 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.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) All patients treated with the PD-1 blockade nivolumab or pembrolizumab
2) All patients treated with the CTLA-4 blockade ipilimumab
3) All patients treated with the PD-L1 blockade atezolizumab or durvalumab
4) Patients who can give written informed consent
Key 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
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahide Fukudo
Organization Asahikawa Medical University
Division name Department of Hospital Pharmacy and Pharmacology
Zip code
Address 2-1-1-1 Midorigaokahigashi, Asahikawa 078-8510, Japan
TEL 0166-69-3482
Email mfukudo@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahide Fukudo
Organization Asahikawa Medical University
Division name Department of Hospital Pharmacy and Pharmacology
Zip code
Address 2-1-1-1 Midorigaokahigashi, Asahikawa 078-8510, Japan
TEL 0166-69-3482
Homepage URL
Email mfukudo@asahikawa-med.ac.jp

Sponsor
Institute Department of Hospital Pharmacy and Pharmacology, Asahikawa Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 旭川医科大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 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

Management information
Registered date
2018 Year 06 Month 18 Day
Last modified on
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037665

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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