UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of interindividual factors in nivolumab pharmacokinetics and adverse events in Japanese patients with non-small-cell lung cancer and renal cell cancer
Acronym	Investigation of interindividual factors in nivolumab pharmacokinetics and adverse events in Japanese patients with non-small-cell lung cancer and renal cell cancer
Scientific Title	Investigation of interindividual factors in nivolumab pharmacokinetics and adverse events in Japanese patients with non-small-cell lung cancer and renal cell cancer
Scientific Title:Acronym	Investigation of interindividual factors in nivolumab pharmacokinetics and adverse events in Japanese patients with non-small-cell lung cancer and renal cell cancer
Region	Japan

Condition
Condition	Non-small-cell lung cancer, renal cell cancer
Classification by specialty	Pneumology Urology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	This study evaluates the interindividual variability of serum nivolumab disposition determined by LC-MS/MS and nivolumab-related adverse events by investigating the patient background, concentration of serum proteins related with nivolumab, 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	Serum nivolumab concentration just before dosing at 7th administration or later
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 nivolumab for non-small-cell lung cancer or renal cell 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	053-435-2111
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	2020 Year 07 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	2017 Year 11 Month 21 Day
Date of IRB	2017 Year 12 Month 28 Day
Anticipated trial start date	2018 Year 01 Month 08 Day
Last follow-up date	2023 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study design: Observational study Object recruitment: All patients who visit our hospital and meet the selection criteria from January 2018 to 2023 Primary outcome: Serum nivlumab concentration just before dosing at 7th administration or later Secondary outcome: 1. Serum concentrations of total protein, albumin, and immunoglobulins 2. Concomitant drug 3. Serum concentrations of inflammatory cytokines and immune complex 4. Cachexia stage 5. Therapeutic efficacy 6. Adverse events and its grade 7. Laboratory values 8. Patient characteristics 9. Anti-nivolumab antibody 10. Serum concentration and genetic variants of PD-1, PD-L1, and L2

Management information
Registered date	2020 Year 07 Month 13 Day
Last modified on	2020 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046916