UMIN-CTR Clinical Trial

Basic information
Public title	Molecular Targeted Vaccine Therapy for Cancer
Acronym	Molecular Targeted Vaccine Therapy for Cancer
Scientific Title	Assessment of the Effectiveness of HER2 Vaccine Therapy
Scientific Title:Acronym	HER2 Vaccine Therapy
Region	Japan

Condition
Condition	Esophageal Cancer, Gastric Cancer, Breast Cancer, Colorectal Cancer, Bladder Cancer, Biliary Tract Cancer
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Endocrinology and Metabolism Hematology and clinical oncology Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Endocrine surgery Breast surgery Obsterics and gynecology Urology Laboratory medicine Operative medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Assess the efficacy of HER2 vaccine therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum HER2 concentration Tumor marker concentrations
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Vaccine
Interventions/Control_1	Injection of HER2 vaccine
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Must have histologically confirmed solid tumor 2. Women must not be pregnant 3. Doesn't have heart disease 4. Ability to understand and the willingness to sign a written informed consent document; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
Key exclusion criteria	1. Patients with intracranial bleeding 2. Patients who have evidence of active infection that requires antibiotic therapy; patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment 3. Patients with known active human immunodeficiency virus (HIV), hepatitis A, hepatitis B, or hepatitis C infection 4. Patients with serious cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases 5. Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible 6. Splenectomized patients 7. Autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermatomyositis, or a vasculitic syndrome 8. Patients who have developed anaphylactic responses to other vaccines 9. History of congestive heart failure, coronary artery disease and myocardial infarction; active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention 10. Patients on HER2 targeted therapies, such as Herceptin, Perjeta, Kadcyla, and Enhertu.
Target sample size	88

Research contact person
Name of lead principal investigator	1st name Takayoshi Middle name Last name Ubuka
Organization	International Cancer Laboratory Co., Ltd.
Division name	Division of Research Initiatives and Development
Zip code	104-0014
Address	2nd Floor, No. 3 Toho Bldg. 1-6-8 Shintomi, Chuo-ku, Tokyo
TEL	03-6426-0316
Email	t.ubuka@ic-lab.jp

Public contact
Name of contact person	1st name Ubuka Middle name Last name Takayoshi
Organization	International Cancer Laboratory Co., Ltd.
Division name	Division of Research Initiatives and Development
Zip code	104-0014
Address	2nd Floor, No. 3 Toho Bldg. 1-6-8 Shintomi, Chuo-ku, Tokyo
TEL	03-6426-0316
Homepage URL
Email	t.ubuka@ic-lab.jp

Sponsor
Institute	International Cancer Laboratory Co., Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nihonbashi Sakura Clinic IRB
Address	5th Floor Inamura Bldg. 1-9-2 Kayabacho Nihonbashi Chuo-ku, Tokyo
Tel	03-6661-9061
Email	c-irb_ug@neues.co.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	名古屋がん中央クリニック（愛知県） 医療法人知慎会　JTKクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2022 Year 05 Month 06 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	Open public recruiting
Date of protocol fixation	2022 Year 04 Month 27 Day
Date of IRB	2022 Year 04 Month 27 Day
Anticipated trial start date	2022 Year 05 Month 06 Day
Last follow-up date	2024 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	2022 Year 05 Month 06 Day
Last modified on	2022 Year 05 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054348

Research Plan
Registered date	File name
2022/05/09	研究計画書　第5版（2022年4月27日修正）.pdf

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.