UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023665 |
|---|---|
| Receipt number | 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 | 2021/05/14 12:55:26 |
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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 | Kan |
| Middle name | |
| Last name | Yonemori |
Organization
National Cancer Center Hospital
Division name
Department of Breast and Medical Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
NCCH1510_OSCAR_office@ml.res.ncc.go.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Matsui |
Organization
National Cancer Center Hospital
Division name
Clinical Trial Support Office
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
NCCH1510_OSCAR_office@ml.res.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
NCC_IRB
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2021 | 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
| 2016 | Year | 08 | Month | 18 | Day |
Last modified on
| 2021 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027020
