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

Clinical Study of a Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Resectable Pancreatic Cancer
• Intervention / Treatment: Other: GM-CSF; Biological: iNeo-Vac-P01

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yang Liu, M.D.; Phone Number: 13666601475; Email: yangliuqq2003@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Yang Liu, M.D.; Phone Number: 13666601475; Email: yangliuqq2003@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria：

1. Must freely sign informed consent;
2. Aged 18 to 70 years old;
3. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma;
4. Must provide all exons of tumor tissue sequencing data, transcriptome sequencing data and the peripheral blood of all exons sequencing data;
5. ECOG score is 0 or 1;
6. Completed an R0 or R1 surgical resection as determined by pathology；
7. Completion of at least 4 months of adjuvant chemotherapy with ticgio monotherapy or mFOLFIRINOX;
8. Completion of imaging records 1 week before personalized immunotherapy, including but not limited to full-body PET-CT and brain MRI,
9. The end of chemotherapy is followed by a one-week natural washout period；

10. Haematological index：

    • White blood cells ≥ 3500 / MCL
    • Lymphocytes > 800/ MCL
    • neutrophils > 1500/ MCL
    • Platelets > 100000 / MCL
    • Hemoglobin >10.0g/dL
    • Total serum bilirubin <1.5× upper limit of normal value (ULN)
    • AST/ALT<2.0 times the upper limit of normal
    • Serum creatinine <1.5 times the upper limit of normal；
11. Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial;
12. Good compliance, able to follow research protocols and follow-up procedures.

Exclusion Criteria:

1. Evidence of disease recurrence or metastasis following surgical resection at any time prior to the first vaccination administration.
2. Diagnosed as other malignant tumor;
3. No neoantigen was found in the sequencing data;
4. There have been bone marrow or stem cell transplants;
5. Received systemic glucocorticoids with immunosuppressants;
6. 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;
7. With HIV, HCV, HBV infection, severe asthma, autoimmune disease, immunodeficiency or treated with immunosuppressive drugs;
8. Uncontrolled complications include, but are not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, and arrhythmias;
9. Infected with herpes virus (except those with scabs of more than 4 weeks)；
10. Infected with respiratory virus (except those who have recovered for more than 4 weeks);
11. Have severe coronary or cerebrovascular disease, or other conditions considered ineligible by the investigator;
12. Drug abuse. Clinical, psychological or social factor result in affecting informed consent or research implementation;
13. Have a history of drug or polypeptide allergies, or people who are allergic to other potential immunotherapies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized neoantigen vaccines; 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	Other: GM-CSF; GM-CSF: 40 mcg; Other Names: immune adjuvant; granulocyte-macrophage colony stimulating factor; Biological: iNeo-Vac-P01; iNeo-Vac-P01 (peptides)： 300 mcg per peptide; Other Names: Neoantigen peptides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival(OS)	Time from surgery to death or last follow-up	4 years

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital
• Collaborators: Hangzhou Neoantigen Therapeutics Co., Ltd.
• Investigators: Principal Investigator: Yang Liu, Liu, Zhejiang Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Anticipated): March 30, 2025
• Study Completion (Anticipated): March 30, 2025

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Sargramostim; Molgramostim
• Other Study ID Numbers: INEO-P-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No