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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027873
Receipt No. R000031911
Scientific Title Predictive efficacy of serum soluble PD-L1 on patients with metastatic renal cell carcinoma treated with Nivolumab
Date of disclosure of the study information 2017/09/01
Last modified on 2018/01/25

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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
Middle name
Last name Masato Fujisawa
Organization Kobe University Graduate School of Medicine
Division name Department of Urology
Zip code
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
Middle name
Last name Nobuyuki Hinata
Organization Kobe University Graduate School of Medicine
Division name Department of Urology
Zip code
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
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

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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 02 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

Management information
Registered date
2017 Year 06 Month 22 Day
Last modified on
2018 Year 01 Month 25 Day


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

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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