UMIN-CTR Clinical Trial

Basic information
Public title	A Multicenter, Open-label, Uncontrolled Phase II study of ONO-4538 [immune-checkpoint inhibitor] for cutaneous angiosarcoma ( Angio Check Study)
Acronym	A Multicenter, Open-label, Uncontrolled Phase II study of ONO-4538 [immune-checkpoint inhibitor] for cutaneous angiosarcoma ( Angio Check Study)
Scientific Title	A Multicenter, Open-label, Uncontrolled Phase II study of ONO-4538 [immune-checkpoint inhibitor] for cutaneous angiosarcoma ( Angio Check Study)
Scientific Title:Acronym	A Multicenter, Open-label, Uncontrolled Phase II study of ONO-4538 [immune-checkpoint inhibitor] for cutaneous angiosarcoma ( Angio Check Study)
Region	Japan

Condition
Condition	Cutaneous angiosarcoma
Classification by specialty	Dermatology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Multicenter study to evaluate the efficacy and safety of ONO-4538 in the treatment of advanced/recurrent cutaneous angiosarcoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Disease control rate, overall survival, progression free survival, time to response, duration of response

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	ONO-4538(Nivolumab) 480mgQ4w
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	Patients who have been confirmed by histology or cytology to be cutaneous angiosarcoma and cannot be cured by surgery and radiation therapy Patients who have received prior chemotherapy with paclitaxel, which is the standard treatment for the target disease
Key exclusion criteria	Patients with a current history of autoimmune disease or past history of chronic or recurrent autoimmune disease.
Target sample size	23

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Fujisawa
Organization	University of Tsukuba
Division name	Dermatology
Zip code	305-8576
Address	2-1-1 Amakubo, Tsukuba, Ibaraki
TEL	029-853-3128
Email	fujisan@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Koichi Middle name Last name Hashimoto
Organization	University of Tsukuba
Division name	T-CReDO
Zip code	305-8576
Address	2-1-1 Amakubo, Tsukuba, Ibaraki
TEL	029-853-3326
Homepage URL
Email	koichi.hashimoto@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Ono pharmaceutical
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Tsukuba
Address	2-1-1 Amakubo, Tsukuba, Ibaraki
Tel	029-853-3326
Email	kimizuka.hiroe.ga@un.tsukuba.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCT2031200020
Org. issuing International ID_1	Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	23
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2020 Year 02 Month 01 Day
Date of IRB	2020 Year 03 Month 01 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 18 Day
Last modified on	2022 Year 01 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049134