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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022007
Receipt No. R000025359
Scientific Title Phase II trial of nivolumab in patients with unresectable or recurrent thymic carcinoma; PRIMER trial
Date of disclosure of the study information 2016/06/01
Last modified on 2020/04/23

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Basic information
Public title Phase II trial of nivolumab in patients with unresectable or recurrent thymic carcinoma; PRIMER trial
Acronym Phase II trial of nivolumab in patients with unresectable or recurrent thymic carcinoma
Scientific Title Phase II trial of nivolumab in patients with unresectable or recurrent thymic carcinoma; PRIMER trial
Scientific Title:Acronym Phase II trial of nivolumab in patients with unresectable or recurrent thymic carcinoma
Region
Japan

Condition
Condition thymic carcinoma
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this trial is to assess the efficacy and safety of nivolumab in patients with unresectable or recurrent thymic carcinoma, who had received at least one previous platinum-based chemo(radio)therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes

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 Administration of 3 mg/kg of nivolumab every two weeks as an intravenous infusion
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 1)Patients with thymic carcinoma confirmed by tissue or cytological diagnosis
2)Correspond to any of the following
a. Unresectable Masaoka-Koga classification IIIa or IIIb thymic carcinoma
b. Masaoka-Koga classification IVa or IVb thymic carcinoma
c. Recurrent thymic carcinoma
3)Aged 20 or above at the time of registration
4)Performance Status 0 or 1
5)Patients who had received at least one previous platinum-based chemo (radio) therapy
6)Patients who had not received systematic corticosteroid at a daily dose of more than 10 mg in prednisolone equivalent or immunosuppressant drug within 14 days before registration
7)Patients who had not received anti-cancer drug or other study drug within 28 days before registration
8)Patients with the following values in laboratory tests performed within 14 days before registration, provided that they had not received G-CSF or blood transfusion within 14 days before the blood collection
a. Neutrophil count >=1500 / mm3
b. Platelet count>=100000 / mm3
c. Hemoglobin>=9.0 g/dL
d. AST<=100 U/L
e. ALT<=100 U/L
f. Total bilirubin<=1.5 mg/dL
g. Creatinine<=0.5 mg/dL
9)Patients who achieved an SpO2 of 92% or more under room air conditions within 14 days before registration
10)Patients gave written informed consent for this trial
Key exclusion criteria 1)Patients with active double cancer (except for completely resected basal cell cancer, stage I squamous cell cancer, carcinoma in situ, intramucosal cancer, superficial bladder cancer, or gastrointestinal cancer resected by ESD or EMR, or other cancer free of relapse for 5 years)
2)Patients who have an infection requiring systematic therapy
3)Patients with active gastrointestinal ulceration
4)Patients with current or previous pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings
5)Patients with a current or previous severe hypersensitive reaction to an antibody product
6)Patients with a current or chronic and recurrent auto immune disease (Patients could be enrolled if they had type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, skin disorder requiring no systematic therapy, or an auto immune disease predicted to remain free of disease in the absence of external factors)
7)Patients who are HIV antibody-positive, HBsAg-positive, or HCV antibody-positive (even though a patient was HCV antibody-positive, the patient could be enrolled if the patient was HCV-RNA-negative)
8)Patients who are HBsAg-negative, but HBs antibody-positive or HBc antibody-positive, and HCV-DNA quantitative test is positive
9)Pregnant or breast-feeding women, or women suspected of being pregnant
10)Patients with a psychiatric disease or psychological symptoms
Target sample size 33

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

Public contact
Name of contact person
1st name
Middle name
Last name Tamie Sukigara
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 tsukigar@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 Japanese Governmental office
Nationality of Funding Organization

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

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、国立がん研究センター東病院、東京都立駒込病院、公益財団法人がん研究会有明病院、愛知県がんセンター中央病院、兵庫県立がんセンター、独立行政法人国立病院機構四国がんセンター、独立行政法人国立病院機構九州がんセンター

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications https://www.sciencedirect.com/science/article/pii/S0959804919302096?via%3Dihub
Number of participants that the trial has enrolled 15
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 03 Month 28 Day
Date of IRB
2016 Year 06 Month 01 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2019 Year 06 Month 30 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 04 Month 20 Day
Last modified on
2020 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025359

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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