UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000025359