UMIN-CTR Clinical Trial

Basic information
Public title	Predictive efficacy of serum soluble PD-L1 on patients with metastatic renal cell carcinoma treated with Nivolumab
Acronym	Serum soluble PD-L1 and nibolumab in patients with renal cell carcinoma
Scientific Title	Predictive efficacy of serum soluble PD-L1 on patients with metastatic renal cell carcinoma treated with Nivolumab
Scientific Title:Acronym	Serum soluble PD-L1 and nibolumab in patients with renal cell carcinoma
Region	Japan

Condition
Condition	advanced renal cell carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate treatment efficacy of nivolumab on patients of metastatic renal cell carcinoma with high soluble PD-L1
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Overall survival Responce rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Nivolumab
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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Metastatic or unresectable renal cell carcinoma
Key exclusion criteria	History with other malignancies Pregnant
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Fujisawa
Organization	Kobe University Graduate School of Medicine
Division name	Department of Urology
Zip code	650-0017
Address	7-5-1, Kusunoki-cho, Kobe, Japan
TEL	078-382-6155
Email	uro6155@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Nobuyuki Middle name Last name Hinata
Organization	Kobe University Graduate School of Medicine
Division name	Department of Urology
Zip code	650-0017
Address	7-5-1, Kusunoki-cho, Kobe, Japan
TEL	078-382-6155
Homepage URL
Email	hinata@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD. Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kobe University Graduate School of Medicine
Address	7-5-2, Kusunoki-cho, Tyuo-ku, Kobe, Japan
Tel	078-382-6155
Email	ykrbando@med.kobe-u.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	2017 Year 09 Month 01 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	No longer recruiting
Date of protocol fixation	2017 Year 12 Month 02 Day
Date of IRB	2017 Year 10 Month 23 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 22 Day
Last modified on	2022 Year 02 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031911