臨床研究等提出・公開システム

Date of registration	Sept. 01, 2015
Last modified on	June. 06, 2022
Trial ID	jRCT2080222952

Scientific Title	Multicenter, open-label, randomized study in patients with ovarian cancer(ONO-4538-23)
Public Title	A phase III study of ONO-4538(ONO-4538-23)

Completion Date or Terminated date	June. 10, 2021
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results	Sept. 16, 2021
URL hyperlink(s) related to results and publications	https://ascopubs.org/doi/full/10.1200/JCO.21.00334

Plan to share IPD	Yes
Plan description	https://www.ono.co.jp/eng/rd/policy.html
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address
	Phone Number
	E-mail Address	clinical_trial@ono.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address
	Phone Number	+81-120-626-190（受付時間：土・日・祝日を除く9:00−17:00）
	E-mail Address	clinical_trial@ono.co.jp

Recruitment Status	completed

Date of First Enrolment		Oct. 21, 2015
Target Sample Size		316
Study Type		Interventional
Study Design	Study Design	A multicenter, open-label, randomized study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1. Histologically confirmed epithelial ovarian cancers (including fallopian tube and peritoneal cancer) 2. Estimated life expectancy of at least 90 days at the time of informed consent 3. Patients with disease progression or recurrence during platinum-based treatment or less than 6 months after the last dose of a platinum agent
	Exclusion Criteria	1. Patients with prior history of severe hypersensitivity to other antibody products 2. Patient with multiple cancers
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Female
Health Condition or Problem Studied		Ovarian cancer
Intervention(s)		investigational material(s) Generic name etc : ONO-4538 INN of investigational material : nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous administration control material(s) Generic name etc : Liposomal doxorubicin INN of investigational material : Doxorubicin Therapeutic category code : 423 Antitumor antibiotics and preparations Dosage and Administration for Investigational material : Intravenous administration Generic name etc : gemcitabine INN of investigational material : gemcitabine Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : Intravenous administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Overall survival
Secondary Outcome		safety efficacy Response rate, progression-free survival, disease control rate, QOL, safety, etc.

Primary Sponsor	ONO PHARMACEUTICAL CO.,LTD.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Iwate Medical University Hospital
Address of IRB	19-1,Uchimaru,Morioka,Iwate
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Sept. 18, 2015

Secondary ID No.	JapicCTI-153004
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
14	June. 06, 2022	(this page)	Changes
13	Oct. 14, 2020	Detail	Changes
12	July. 16, 2019	Detail	Changes
11	Dec. 17, 2018	Detail	Changes
10	Feb. 12, 2018	Detail	Changes
9	Feb. 12, 2018	Detail	Changes
8	May. 22, 2017	Detail	Changes
7	May. 22, 2017	Detail	Changes
6	Nov. 25, 2016	Detail	Changes
5	Nov. 25, 2016	Detail	Changes
4	Dec. 14, 2015	Detail	Changes
3	Dec. 14, 2015	Detail	Changes
2	Sept. 01, 2015	Detail	Changes
1	Sept. 01, 2015	Detail

List of change history