UMIN-CTR Clinical Trial

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
Email	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
Email	NCCH1510_OSCAR_office@ml.res.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	NCC_IRB
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel	03-3542-2511
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027020