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

• ClinicalTrials.gov Identifier: NCT04810910
• Recruitment Status: Recruiting
• First Posted: March 23, 2021
• Last Update Posted: November 16, 2021
• Sponsor: Zhejiang Provincial People's Hospital
• Collaborator: Hangzhou Neoantigen Therapeutics Co., Ltd.
• Information provided by (Responsible Party): Liu Yang, Zhejiang Provincial People's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Resectable Pancreatic Cancer	Biological: iNeo-Vac-P01; Other: GM-CSF	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Study of a Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
• Actual Study Start Date: March 30, 2021
• Estimated Primary Completion Date: March 30, 2025
• Estimated Study Completion Date: March 30, 2025

Arms and Interventions

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	Biological: iNeo-Vac-P01; iNeo-Vac-P01 (peptides)： 300 mcg per peptide; Other Name: Neoantigen peptides; Other: GM-CSF; GM-CSF: 40 mcg; Other Names: immune adjuvant; granulocyte-macrophage colony stimulating factor

Outcome Measures

Primary Outcome Measures :

1. Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: 1 years ]
   Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
2. Relapse Free Survival(RFS) [ Time Frame: 4 years ]
   Time from surgery to any recurrence

Secondary Outcome Measures :

1. Overall Survival(OS) [ Time Frame: 4 years ]
   Time from surgery to death or last follow-up

Other Outcome Measures:

1. Measurement of CD4/CD8 T lymphocyte subsets [ Time Frame: 2 years ]
2. The polypeptide antigen - induced IFN-γ T cells responses [ Time Frame: 2 years ]
3. Peripheral blood T cell receptor sequencing analysis [ Time Frame: 2 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Yang Liu, M.D.; 13666601475; yangliuqq2003@163.com

Locations

China, Zhejiang

Zhejiang Provincial People's Hospital; Recruiting

Hangzhou, Zhejiang, China

Contact: Yang Liu, M.D. 13666601475 yangliuqq2003@163.com

Sponsors and Collaborators

Zhejiang Provincial People's Hospital

Hangzhou Neoantigen Therapeutics Co., Ltd.

Investigators

• Principal Investigator: Yang Liu, Liu; Zhejiang Provincial People's Hospital

More Information

• Responsible Party: Liu Yang, MD, Zhejiang Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT04810910
• Other Study ID Numbers: INEO-P-005
• First Posted: March 23, 2021
• Last Update Posted: November 16, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Molgramostim; Sargramostim; Immunologic Factors; Physiological Effects of Drugs; Antineoplastic Agents