UMIN-CTR Clinical Trial

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
Email	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
Email	pharmacyham-adm@umin.ac.jp

Sponsor
Institute	Department of Hospital pharmacy, Hamamatsu University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050148