臨床研究等提出・公開システム

Date of registration	Mar. 03, 2016
Last modified on	June. 28, 2024
Trial ID	jRCT2080223128

Scientific Title	A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma(ONO-4538-40/CA209548)
Public Title	A Phase 3 Study of ONO-4538/BMS-936558(ONO-4538-40/CA209548)

Completion Date or Terminated date	April. 09, 2024
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
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
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	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Phone Number	+81-120-626-190
	E-mail Address	clinical_trial@ono-pharma.com

Contact for Public Queries	Name
	Contact Name for Public Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Phone Number	+81-120-626-190
	E-mail Address	clinical_trial@ono-pharma.com

Recruitment Status	completed

Date of First Enrolment		May. 09, 2016
Target Sample Size		693
Study Type		Interventional
Study Design	Study Design	A Randomized, Single blind Study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1. Newly-diagnosed GBM 2. Tumor test result shows MGMT methylated or indeterminate tumor subtype 3. Karnofsky performance status of >= 70 (able to care for self) 4. Substantial recovery from surgical resection
	Exclusion Criteria	1. Biopsy-only of GBM with less than 20% of tumor removed 2. Prior treatment for GBM (other than surgical resection) 3. Any known tumor outside of the brain 4. Recurrent or secondary GBM 5. Active known or suspected autoimmune disease
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Glioblastoma
Intervention(s)		investigational material(s) Generic name etc : ONO-4538/BMS-936558 INN of investigational material : nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous infusion control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Intravenous infusion
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Progression free survival (PFS), Blinded Independent Central Review(BICR) assessed, Overall survival (OS)
Secondary Outcome		efficacy Overall survival rate at 24 months (OS[24]), Progression free survival (PFS), Investigator assessed

Primary Sponsor	ONO PHARMACEUTICAL CO.,LTD.
Secondary Sponsor	Bristol-Myers Squibb

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Chiba University Hospital Institutional Review Board
Address of IRB	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	May. 02, 2016

Secondary ID No.	NCT02667587
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-163183
Name of Other Registries

Countries / Regions of Recruitment	Japan/North America/Europe/Oceania/Middle East

History of Changes

No	Publication date
18	June. 28, 2024	(this page)	Changes
17	June. 21, 2024	Detail	Changes
16	Aug. 10, 2023	Detail	Changes
15	Oct. 12, 2022	Detail	Changes
14	Oct. 14, 2020	Detail	Changes
13	Jan. 10, 2020	Detail	Changes
12	July. 16, 2019	Detail	Changes
11	Dec. 17, 2018	Detail	Changes
10	Oct. 01, 2018	Detail	Changes
9	Oct. 01, 2018	Detail	Changes
8	Nov. 13, 2017	Detail	Changes
7	Nov. 13, 2017	Detail	Changes
6	Feb. 24, 2017	Detail	Changes
5	Feb. 24, 2017	Detail	Changes
4	July. 15, 2016	Detail	Changes
3	July. 15, 2016	Detail	Changes
2	Mar. 03, 2016	Detail	Changes
1	Mar. 03, 2016	Detail

List of change history