UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027873 |
|---|---|
| Receipt number | 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 | 2022/02/10 18:08:52 |
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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 | 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
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
hinata@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031911
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
