UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043914 |
|---|---|
| Receipt number | R000050148 |
| Scientific Title | Investigation of associations between blood pembrolizumab level and clinical factors for immune-related adverse events in Japanese patients with urological cancers |
| Date of disclosure of the study information | 2021/04/13 |
| Last modified on | 2021/04/13 15:38:44 |
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Basic information
Public title
Investigation of associations between blood pembrolizumab level and clinical factors for immune-related adverse events in Japanese patients with urological cancers
Acronym
Investigation of associations between blood pembrolizumab level and clinical factors for immune-related adverse events in Japanese patients with urological cancers
Scientific Title
Investigation of associations between blood pembrolizumab level and clinical factors for immune-related adverse events in Japanese patients with urological cancers
Scientific Title:Acronym
Investigation of associations between blood pembrolizumab level and clinical factors for immune-related adverse events in Japanese patients with urological cancers
Region
| Japan |
Condition
Condition
urological cancers, including renal cell cancer, urothelial cancer, and bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study evaluates the associations of blood pembrolizumab level with the patient characteristics, clinical laboratory data, blood levels of clinical factors for immune-related adverse events, and genetic variants of antibody receptor transporters.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlations between blood levels of pembrolizumab just before dosing at 2nd administration or later and clinical factors for immune-related adverse events
Key secondary outcomes
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. Patients treated with intravenous pembrolizumab for urological cancer
2. Patients receiving written informed consent
Key exclusion criteria
Patients who are judged by physicians as inappropriate for study enrollment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Kawakami |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital pharmacy
Zip code
4313192
Address
1-20-1 Handayama, Hamamatsu 431-3192
TEL
053-435-2763
pharmacyham-adm@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Naito |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hospital pharmacy
Zip code
4313192
Address
1-20-1 Handayama, Hamamatsu 431-3192
TEL
053-435-2763
Homepage URL
pharmacyham-adm@umin.ac.jp
Sponsor or person
Institute
Department of Hospital pharmacy, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Hospital pharmacy, Hamamatsu University School of Medicine
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
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Hamamatsu 431-3192
Tel
0534352111
rinri@hama-med.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Method of recruitment: All patients who visited our institution between October 2019 and September 2024 and met the selection criteria.
Primary outcome: Relationship between blood levels of pembrolizumab just before dosing at 2nd administration and clinical factors for immune-related adverse events.
Secondary outcomes:
1. Serum pembrolizumab concentrations during the withdrawal period and just before dosing
2. Laboratory values (adrenocortical function, thyroid function, blood cell count, serum globulin, serum albumin)
3. Incidence, timing, and severity of immune-related adverse events (thyroid dysfunction, skin disorders, diarrhea)
4. Blood levels of inflammatory and non-inflammatory cytokines (IL-1beta, IL-6, IL-10, IL-17, IFN-gamma, TGF-beta, TNF-alfa)
5. Blood levels of biomarkers for drug-metabolizing enzymes (4beta-hydroxycholesterol, 25-hydroxyvitamin D, microRNA)
6. Medical history
7. Chemotherapy history
8. Treatment response
9. Genetic polymorphisms of PD-1, PD-L1, PD-L2, FcRn, CYP3A5
10. Blood levels of immune complexes (C1q)
11. Concomitant medications
12. Blood levels of anti-pembrolizumab antibody
13. Cancer cachexia progression
14. Basic patient information (age, gender, weight)
15. Blood levels of soluble fractions of PD-1, PD-L1, and PD-L2
Management information
Registered date
| 2021 | Year | 04 | Month | 13 | Day |
Last modified on
| 2021 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050148
