UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial of personalized peptide vaccination for nine kinds of cancers
Acronym	A phase II trial of peptide vaccination for nine kinds of cancers
Scientific Title	A phase II trial of personalized peptide vaccination for nine kinds of cancers
Scientific Title:Acronym	A phase II trial of peptide vaccination for nine kinds of cancers
Region	Japan

Condition
Condition	Prostate cancer, Urothelial cancer, Breast cancer, Lung cancer, Ovarian cancer, Gastric cancer, Colon cancer, Liver cancer, Pancreatic cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Breast surgery Obsterics and gynecology Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	It became clear so far that an effect did not appear to the patient that an MCP-1 level was low in the blood and the peptide which was easy to appear of the clinical response existed from a clinical study result of the peptide vaccinotherapy that I gave. From these knowledge, I do a patient having low MCP-1 level out of the blood in the final examination with the adaptation outside and decide recommendation peptide and it is given priority with recommendation peptide and chooses peptide. It is intended to weigh the immunoreactivity and a clinical response against conventional peptide vaccinotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Peptide-specific immune responses in PBMCs at the end of 1st course
Key secondary outcomes	Overall suvival Adverse events of the entire period(safety assessments)

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	Vaccine
Interventions/Control_1	For Prostate cancer,Urothelial cancer, Breast cancer, Lung cancer, Ovarian cancer, Gastric cancer, Colon cancer, Liver cancerand Pancreatic cancer patients I choose a maximum of four kinds as priority and give recommendation peptide subcutaneously from 31 kinds of vaccine candidate peptide. The dose of the peptide assumes it 3 mg because of one peptide. I give four times of dosage every week in dosage four times, every other week for the interdose interval and assume eight times in total 1 course. It is said that the dosage is possible continuously for patient hope after 2nd course.
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	The subjects must satisfy the following conditions. 1) A standard under treatment or treatment resistant malignant tumor and the Prostate cancer, Urothelial cancer, Breast cancer, Lung cancer, Ovarian cancer, Gastric cancer, Colon cancer, Liver cancer or Pancreatic cancer which is diagnosed. 2) Patients must be a score level 0 to 2 of ECOG performance status. 3) Patients must be expected to survive more than 3 months. 4) Patient's laboratory data must satisfy the followings WBC > and = 2500/mm3 Lymphocyte > and = 900/mm3 Hb > and = 8.0g/dL Platelet > and = 80000/mm3 Serum Creatinine = and < 2.0mg/dL Serum total bilirubin = and < 2.5mg/dL 5) Plasma MCP 1 > and = 30pg/mL (ELISA method) 6) Patients must be more 18 years old 7) Written informed consent must be obtained from patients. 8) Patients must be positive for HLA class IA (-A2, -A3, -A11, -A24, -A26, -A31 or -A33) 9) Distance opening more than at least 4 weeks when Nivolumab or Pembrolizumab was used as previous treatment 10) Patient must have IgGs reactive to at least 2 of candidate peptide restricted to the patient's HLA types. And at least one being recommendation peptides.
Key exclusion criteria	The following patients must be excluded 1) Patients with severe underlying diseases conditions (active and severe infection, circulatory diseases, respiratory diseases, renal diseases, immunodeficiencies, disturbance of coagulation,et al.) 2) Patients with the past history of severe allergic reactions. 3) Females Pregnant or nursing patients. Males Patients who do not accept contraception during vaccination period and until 70 days after the last vaccination. 4) Patients who are judged inappropriate for entry to this clinical trial by examination medical attendant.
Target sample size	900

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigeru Yutani
Organization	Kurume University
Division name	Cancer Vaccine Center
Zip code
Address	155-1 Kokubu-machi Kurume-city Fukuoka-Pref. JAPAN, 839-0863
TEL	+81-942-27-5210
Email	yutani@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shigeru Yutani
Organization	Kurume University
Division name	Cancer Vaccine Center
Zip code
Address	155-1 Kokubu-machi Kurume-city Fukuoka-Pref JAPAN, 839-0863
TEL	+81-942-27-5210
Homepage URL	http://www.med.kurume-u.ac.jp/med/cvc
Email	yutani@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University
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
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	久留米大学がんワクチンセンター（福岡県）、仙台厚生病院（宮城県）、内藤病院（福岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 05 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	2017 Year 10 Month 27 Day
Date of IRB	2017 Year 10 Month 27 Day
Anticipated trial start date	2017 Year 11 Month 05 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry	2022 Year 11 Month 30 Day
Date trial data considered complete	2022 Year 12 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 11 Month 01 Day
Last modified on	2019 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034013