UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-disciplinary research for predictive factors of nivolumab effect on unresectable or metastatic renal cell carcinoma
Title of the study (Brief title)	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	Kazutake Tsujikawa
Organization	Graduate School of Pharmaceutical Sciences, Osaka University
Division name	Laboratory of Molecular and Cellular Physiology
Address	1-6 Yadaoka, Suita, Osaka
TEL	06-6879-8190
Email	tujikawa@phs.osaka-u.ac.jp

Public contact
Name of contact person	Kazutake Tsujikawa
Organization	Graduate School of Pharmaceutical Sciences, Osaka University
Division name	Laboratory of Molecular and Cellular Physiology
Address	1-6 Yadaoka, Suita, Osaka
TEL	06-6879-8190
Homepage URL
Email	tujikawa@phs.osaka-u.ac.jp

Sponsor
Institute	Graduate School of Pharmaceutical Sciences Department of Urology, Graduate School of Medicine Osaka University
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035941