臨床研究等提出・公開システム

Date of registration	Mar. 07, 2019
Last modified on	Dec. 31, 2023
Trial ID	jRCTs051180102

Scientific Title	Multiinstitutional prospective interventional study of biomarkers to predict efficacy and prognosis after nivolumab in patients with previously treated advanced renal cell carcinoma (URivO)
Public Title	Explorative study for biomarker of nivolumab for renal cell carcinoma (URivO)

Completion date	Dec. 23, 2021
Result actual enrolment	141
Baseline Characteristics	N/A
Participant flow	N/A
Adverse events	N/A
Outcome measures	N/A
Brief summary	The study was discontinued because it was judged inappropriate to continue the study due to inappropriate cases in the study.
Date of posting of results summaries	Dec. 31, 2023

Plan to share IPD	No
Plan description	N/A
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs051180102

Contact for Scientific Queries	Name	Nakano Yuzo
	Affiliation	Kobe University Hospital
	Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe Hyogo
	Telephone	+81-78-382-6155
	E-mail	yznakano@med.kobe-u.ac.jp
Contact for Public Queries	Name	Nanba Isao
	Affiliation	Kobe University Hospital
	Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe Hyogo
	Telephone	+81-78-382-6729
	E-mail	ctrcpj-urivo@med.kobe-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Mar. 20, 2018
Actual date of first enrollment		April. 17, 2018
Target sample size		200
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Advanced renal cell carcinoma with unresectable or metastatic history who had been treated with tyrosine kinase inhibitors Patients who have at least one tumorous lesion of 10 mm over in CT/ MRI and evaluated with RECIST ver1.1 Nuetrphils >= 1500 cells/mm3, platelets >= 75000 cells/mm3, hemoglobin >= 9.0 g/dl, AST <= 78IU/l, ALT <= 85IU/l, total bilirubin <= 1.5 mg/dl, serum creatinine <= 2.0 mg/dl Over 20 years old patients written informed consent
	Exclusion Criteria	Patients who have been administered immune checkpoint inhibitors including nivolumab in the past Patients with active infection of bacteria, fungi or viruses Patients who have a history of malignant tumors other than renal cell carcinoma and are judged not to be cured Patients suffering from other severe acute or chronic diseases Pregnant women or women who may be pregnant or lactating women Patients complicated with psychiatric disorders or psychiatric symptoms and judged to be difficult to participate in the study Patients found to be unacceptable to components of test drugs (or excipients) For other reasons, patients who judged ineligible for participation in this study by physician
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		renal cell carcinoma
Intervention(s)		Nivolumab is administered as 240 mg once daily at 2-week intervals or 480 mg once daily at 4-week intervals by intravenous drip infusion.
Primary Outcome(s)		Best Overall Response
Secondary Outcome(s)		(1)OS (2)PFS (3)DSS (4) AE

Source of Monetary Support / Secondary Sponsor	ONO PHARMACEUTICAL CO., LTD.
Secondary Sponsor	Not applicable

Source of Monetary Support / Secondary Sponsor	Bristol-Myers Squibb Company
Secondary Sponsor	Not applicable

Name of Certified Review Board	Kobe University Clinical Research Ethical Committee
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Telephone	+81-78-382-6669
E-Mail	cerb@med.kobe-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 08, 2019

Secondary ID(s)	UMIN000030400
Issuing Authority	UMIN Clinical Trials Registry(UMIN-CTR)

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
19	Dec. 31, 2023	(this page)	Changes
18	May. 30, 2022	Detail	Changes
17	May. 17, 2022	Detail	Changes
16	April. 21, 2022	Detail	Changes
15	Mar. 14, 2022	Detail	Changes
14	Nov. 09, 2021	Detail	Changes
13	Sept. 16, 2021	Detail	Changes
12	June. 15, 2021	Detail	Changes
11	April. 15, 2021	Detail	Changes
10	Feb. 25, 2021	Detail	Changes
9	Dec. 23, 2020	Detail	Changes
8	Sept. 24, 2020	Detail	Changes
7	May. 28, 2020	Detail	Changes
6	Mar. 11, 2020	Detail	Changes
5	July. 22, 2019	Detail	Changes
4	June. 17, 2019	Detail	Changes
3	April. 25, 2019	Detail	Changes
2	April. 12, 2019	Detail	Changes
1	Mar. 07, 2019	Detail

List of change history