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A phase II trial of personalized peptide vaccination for nine kinds of cancers

A phase II trial of personalized peptide vaccination for nine kinds of cancers - A phase II trial of peptide vaccination for nine kinds of cancers

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029789
Enrollment
900
Registered
2017-11-05
Start date
2017-11-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer, Urothelial cancer, Breast cancer, Lung cancer, Ovarian cancer, Gastric cancer, Colon cancer, Liver cancer, Pancreatic cancer

Interventions

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

Sponsors

Kurume University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Peptide-specific immune responses in PBMCs at the end of 1st course

Secondary

MeasureTime frame
Overall suvival Adverse events of the entire period(safety assessments)

Countries

Japan

Contacts

Public ContactShigeru Yutani

Kurume University Cancer Vaccine Center

yutani@med.kurume-u.ac.jp+81-942-27-5210

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026