臨床研究等提出・公開システム

Date of registration	Aug. 04, 2023
Last modified on	Oct. 06, 2025
Trial ID	jRCT2011230029

Scientific Title	33-104 : Drug Use-Results Survey of OPDIVO (Unresectable advanced/recurrent malignant pleural mesothelioma that has progressed after cancer chemotherapy)
Public Title	33-104 : Drug Use-Results Survey of OPDIVO

Contact for Scientific Queries	Name	Nakao Takafumi
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	1 -5 Doshomachi 2-chome, Chuo-ku, Osaka-shi, Osaka 541-8526, Japan
	Telephone	+81-6-6222-5501
	E-mail	pms_contact_ml@ono-pharma.com
Contact for Public Queries	Name	Nakao Takafumi
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	1 -5 Doshomachi 2-chome, Chuo-ku, Osaka-shi, Osaka 541-8526, Japan
	Telephone	+81-6-6222-5501
	E-mail	pms_contact_ml@ono-pharma.com

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 01, 2018
Actual date of first enrollment		Dec. 18, 2018
Target sample size		100
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with unresectable advanced/recurrent malignant pleural mesothelioma that has progressed after cancer chemotherapy, who have recieved OPDIVO for the first time
	Exclusion Criteria	Patients who have received OPDIVO previously
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Unresectable advanced/recurrent malignant pleural mesothelioma that has progressed after cancer chem
Primary Outcome(s)		[Safety] a) Occurrence status of adverse drug reactions and infections, b) Factors that are considered to affect safety c) Adverse events

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Name of Certified Review Board	Not being included in the items required by GPSP Ordinance, a central IRB is not in place. The study is planned to conduct an IRB at the study site as needed.
Address	none, Hokkaido
Date of approval	Nov. 15, 2018

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Oct. 06, 2025	(this page)	Changes
3	Aug. 06, 2025	Detail	Changes
2	Sept. 04, 2024	Detail	Changes
1	Aug. 04, 2023	Detail

List of change history