UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023665
Receipt No. R000027020
Scientific Title A clinical trial of nivolumab in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma (NCCH1510,OSCAR trial)
Date of disclosure of the study information 2016/08/18
Last modified on 2018/10/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A clinical trial of nivolumab in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma
(NCCH1510,OSCAR trial)
Acronym A clinical trial of nivolumab in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma
(NCCH1510,OSCAR trial)
Scientific Title A clinical trial of nivolumab in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma
(NCCH1510,OSCAR trial)
Scientific Title:Acronym A clinical trial of nivolumab in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma
(NCCH1510,OSCAR trial)
Region
Japan

Condition
Condition clear cell sarcoma and alveolar soft part sarcoma
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of nivolumab in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate (central review)
Key secondary outcomes Overall response rate (investigator's review)
Progression-free survival
Overall survival
Adverse events

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 Nivolumab 240mg/body is administered intravenously biweekly.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Histologically confirmed clear cell sarcoma and alveolar soft part sarcoma
2)Unresectable
3)As for alveolar soft part sarcoma, prior treatment of anti-angiogenic agents(ex.pazopanib,sunitinib)
4)Not having any of the followings;symptomatic brain metastasis at the time of registration,carcinomatous meningitis or spinal metastasis requiring surgical intervention
5)Not having any of the followings;pericardial fluid,pleural effusion or ascites requiring treatment
6)Aged 18 or above
7)Performance Status 0 or 1
8)One or more measurable lesions confirmed by contrast enhanced CT
9)No prior treatment with anti-PD-1 antibody(nivolumab,pembrolizumab etc.),anti-PD-L1 antibody(atezolizumab,avelumab etc.),anti-CTLA-4 antibody(ipilimumab etc.)or other treatment related to T cell regulation
10)Not received systematic corticosteroid at a daily dose of more than 10mg in prednisolone equivalent or immunosuppressant drug within 14days before registration
11)Not received anti-cancer therapy within 28 days before registration
12)Not received operation under general anesthesia within 28days before registration
13)Not received radiotherapy other than the site of lesion within 14days before registration
14)Not received radiotherapy or therapeutic radiopharmaceutical(except for diagnostic radiopharmaceutical)at the site of lesion within 56days before registration
15)Correspond to the following values in laboratory tests performed within 14 days
a.Neutrophil count>=1000/mm3
b.Platelet count>=100000/mm3
c.Hemoglobin>=8.0g/dL
d.AST(GOT)<=100U/L
e.ALT(GPT)<=100U/L
f.Total bilirubin<=1.5mg/dL
g.Creatinine<=1.5mg/dL
16)>=92% of SpO2 under room air conditions within 14days before registration
17)Given consent to contraception
18)Written informed consent
Key exclusion criteria 1)Active double cancer(except for completely resected basal cell carcinoma,stage I squamous cell carcinoma,carcinoma in situ,intramucosal cancer,superficial bladder cancer,gastrointestinal cancer resected by ESD or EMR,and other cancer free of relapse for >=5 years)
2)Infection requiring systematic therapy
3)Active gastrointestinal ulceration
4)Current or previous interstitial pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings
5)Interstitial pattern based on chest imaging or inflammatory change such as active radiation pneumonitis and infectious pneumonia
6)Current or previous severe hypersensitive reaction to antibody products
7)Currently active or previously chronic or recurrent auto immune diseases(except for type 1 diabetes mellitus,hypothyroidism requiring hormone replacement therapy only,skin disorder requiring no systematic therapy,and any autoimmune diseases expected not to relapse without external factors)
8)HIV antibody-positive or HBs-antigen-positive,or HCV antibody-positive:except for HCV-RNA-negative even if HCV antibody-positive
9)Though HBs antigen-negative,HBs antibody-positive or HBc antibody-positive,and HCV-DNA quantitative test positive
10)Pregnant or breast-feeding women or women suspected of being pregnant
11)Psychiatric diseases or psychological symptoms interfering taking part in the trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kan Yonemori
Organization National Cancer Center Hospital
Division name Department of Breast and Medical Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email kyonemor@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mamiko Kawasaki
Organization National Cancer Center Hospital
Division name Clinical Trial Support Office
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email makawasa@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) ONO Pharmaceutical Co.Ltd.

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立がん研究センター中央病院、愛知県がんセンター中央病院、国立病院機構大阪医療センター、岡山大学病院

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 18 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
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
2016 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 18 Day
Last modified on
2018 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027020

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.