UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031541 |
|---|---|
| Receipt number | R000035941 |
| Scientific Title | Multi-disciplinary research for predictive factors of nivolumab effect on unresectable or metastatic renal cell carcinoma |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2018/03/01 18:08:01 |
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Basic information
Public title
Multi-disciplinary research for predictive factors of nivolumab effect on unresectable or metastatic renal cell carcinoma
Acronym
Biomarker exploratory research for nivolumab in renal cell carcinoma
Scientific Title
Multi-disciplinary research for predictive factors of nivolumab effect on unresectable or metastatic renal cell carcinoma
Scientific Title:Acronym
Biomarker exploratory research for nivolumab in renal cell carcinoma
Region
| Japan |
Condition
Condition
Unresectable or metastatic renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effective and efficient biomarkers for Nivolumab in patients with unresectable or metastatic renal cell carcinoma
Basic objectives2
Others
Basic objectives -Others
Exploratory research of biomarker
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression free survival at 6 months after Nivolumab administration
Key secondary outcomes
Efficacy: Overall survival
Safety: Rate of side effects
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Cases with renal cell carcinoma histologically or pathologically
2)Patients with unresectable or metastatic renal cell carcinoma
3)Adequate organ function.
Key exclusion criteria
1)Patients with known or previous antoimmune disease
2)Patients who are currently administered corticosteroids
3)Patients with prior therapy by antibody or drug, specifically aiming at regulation of T-cell functions
4)Patients with history of serious anaphylaxis induced by the component of this agent
5)Dementia or psychological disorder difficult to participate in this clinical study
6)Patients with severe complications (active gastrointestinal ulceration, ileus, bowel obstruction, and uncontrolled diabetes mellitus, etc.)
7)Patients with HIV antibody-positive, HBs antibody-positive, or HCV antibody-positive
8)Patients with HBs antigen-negative, HBs antibody- or HBc antibody-positive, and HBV-DNA quantitative test-positive
9)Pregnant or breast-feeding women or women suspected of being pregnant
10)Other cases judged inappropriate by the attending
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutake Tsujikawa |
Organization
Graduate School of Pharmaceutical Sciences, Osaka University
Division name
Laboratory of Molecular and Cellular Physiology
Zip code
Address
1-6 Yadaoka, Suita, Osaka
TEL
06-6879-8190
tujikawa@phs.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutake Tsujikawa |
Organization
Graduate School of Pharmaceutical Sciences, Osaka University
Division name
Laboratory of Molecular and Cellular Physiology
Zip code
Address
1-6 Yadaoka, Suita, Osaka
TEL
06-6879-8190
Homepage URL
tujikawa@phs.osaka-u.ac.jp
Sponsor or person
Institute
Graduate School of Pharmaceutical Sciences
Department of Urology, Graduate School of Medicine
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd
Bristol-Myers Squibb
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
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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Meta-analysis
Management information
Registered date
| 2018 | Year | 03 | Month | 01 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035941
