UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043039
Receipt number R000049134
Scientific Title A Multicenter, Open-label, Uncontrolled Phase II study of ONO-4538 [immune-checkpoint inhibitor] for cutaneous angiosarcoma ( Angio Check Study)
Date of disclosure of the study information 2021/02/01
Last modified on 2022/01/19 09:08:45

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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 or person

Institute

University of Tsukuba

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049134


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name