UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multiinstitutional prospective interventional study of biomarkers to predict efficacy and prognosis after nivolumab in patients with previously treated advanced renal cell carcinoma.
Title of the study (Brief title)	Multiinstitutional prospective interventional study of biomarkers to predict efficacy and prognosis after nivolumab in patients with previously treated advanced renal cell carcinoma.
Region	Japan

Condition
Condition	Advanced renal cell carcinoma patients who need secondary or tertiary therapy
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Exploratory research for biomarkers related to the therapeutic effect of nivolumab for advanced renal cell carcinoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Best Overall Response
Key secondary outcomes	OS,PFS,DSS

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Advanced renal cell carcinoma with unresectable or metastatic history who had been treated with tyrosine kinase inhibitors, Over 20 years old patients confirmed CT/MRI, Neutrophils > 1500cells/mm2, platelets > 75000cells/mm2, hemoglobin >9.0g/dl, AST < 78IU/l, ALT < 85IU/l, total bilirubin < 1.5mg/dl, serum creatinine > 2.0mg/dl, written informed consent
Key exclusion criteria	Patients who have been administered immune checkpoint inhibitors including nivolumab in the past Patients who have a history of malignant tumors other than renal cell carcinoma and are judged not to be cured Patients who are merging psychiatric symptoms or psychiatric disorders and considered difficult to participate in the study Patients decided not applicable for this study by physician
Target sample size	200

Research contact person
Name of lead principal investigator	Masato Fujisawa
Organization	Kobe University Graduate School of Medicine
Division name	Division of Urology, Department of Surgery
Address	7-5-2, Kusunoki-cho, Chuo-ku Kobe
TEL	078-382-6155
Email	uro6155@med.kobe-u.ac.jp

Public contact
Name of contact person	Hideaki Miyake
Organization	Hamamatsu University School of Medicine
Division name	Department of Urology
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL	053-435-2306
Homepage URL
Email	hmiyake@hama-med.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Ono Pharmaceutical & 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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 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

Management information
Registered date	2017 Year 12 Month 14 Day
Last modified on	2018 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034714