Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy

NCT04810910 | Unknown Phase 1 DMC

• 1 other identifier: INEO-P-005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is evaluating a new type of pancreatic cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of resectable pancreatic cancer, so as to provide a new personalized therapeutic strategy. It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

Conditions

Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Number of participants experiencing clinical and laboratory adverse events (AEs)

  Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0

  1 years

• Relapse Free Survival(RFS)

  Time from surgery to any recurrence

  4 years

Secondary Outcomes (1)

• Overall Survival(OS)

  4 years

Other Outcomes (3)

• Measurement of CD4/CD8 T lymphocyte subsets

  2 years

• The polypeptide antigen - induced IFN-γ T cells responses

  2 years

• Peripheral blood T cell receptor sequencing analysis

  2 years

Study Arms (1)

Personalized neoantigen vaccines

EXPERIMENTAL

iNeo-Vac-P01 (peptides)： 4 x 300 mcg per peptide given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses; GM-CSF: 4 x 40 mcg (total dose 160 mcg) given on days 1, 4, 8, 15, 22, 52, and 82 for a total of 7 doses

Biological: iNeo-Vac-P01; Other: GM-CSF

Interventions

iNeo-Vac-P01 BIOLOGICAL

iNeo-Vac-P01 (peptides)： 300 mcg per peptide

Also known as: Neoantigen peptides

Personalized neoantigen vaccines

GM-CSF OTHER

GM-CSF: 40 mcg

Also known as: immune adjuvant, granulocyte-macrophage colony stimulating factor

Personalized neoantigen vaccines

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must freely sign informed consent;
• Aged 18 to 70 years old;
• Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma;
• Must provide all exons of tumor tissue sequencing data, transcriptome sequencing data and the peripheral blood of all exons sequencing data;
• ECOG score is 0 or 1;
• Completed an R0 or R1 surgical resection as determined by pathology；
• Completion of at least 4 months of adjuvant chemotherapy with ticgio monotherapy or mFOLFIRINOX;
• Completion of imaging records 1 week before personalized immunotherapy, including but not limited to full-body PET-CT and brain MRI,
• The end of chemotherapy is followed by a one-week natural washout period；
• Haematological index：
• White blood cells ≥ 3500 / MCL
• Lymphocytes \> 800/ MCL
• neutrophils \> 1500/ MCL
• Platelets \> 100000 / MCL
• Hemoglobin \>10.0g/dL

You may not qualify if:

• Evidence of disease recurrence or metastasis following surgical resection at any time prior to the first vaccination administration.
• Diagnosed as other malignant tumor;
• No neoantigen was found in the sequencing data;
• There have been bone marrow or stem cell transplants;
• Received systemic glucocorticoids with immunosuppressants;
• Received other polypeptide inoculation 4 weeks before treatment; Patients may not be vaccinated with other polypeptides 8 weeks after the last individualized tumor targeted polypeptides trentment;
• With HIV, HCV, HBV infection, severe asthma, autoimmune disease, immunodeficiency or treated with immunosuppressive drugs;
• Uncontrolled complications include, but are not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, and arrhythmias;
• Infected with herpes virus (except those with scabs of more than 4 weeks)；
• Infected with respiratory virus (except those who have recovered for more than 4 weeks);
• Have severe coronary or cerebrovascular disease, or other conditions considered ineligible by the investigator;
• Drug abuse. Clinical, psychological or social factor result in affecting informed consent or research implementation;
• Have a history of drug or polypeptide allergies, or people who are allergic to other potential immunotherapies.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead
• Hangzhou Neoantigen Therapeutics Co., Ltd.: collaborator

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; Adjuvants, Immunologic; Colony-Stimulating Factors

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Yang Liu, Liu

  Zhejiang Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Liu, M.D.

CONTACT

13666601475; yangliuqq2003@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: March 30, 2021
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)