Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Pancreatic Cancer

Safety, Tolerability and Partial Efficacy Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Pancreatic Cancer

This research study is evaluating a new type of pancreatic cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for advanced pancreatic cancer. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of Chinese patients with advanced pancreatic cancer, so as to provide a new personalized therapeutic strategy for advanced pancreatic cancer patients.

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: Completed
• Conditions: Pancreatic Cancer; Pancreatic Carcinoma
• Intervention / Treatment: Biological: iNeo-Vac-P01; Other: GM-CSF

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must freely sign informed consent;
• Aged 18 to 70 years old;
• The expected survival period is more than 6 months;
• ECOG score is 0 or 1;
• Advanced pancreatic cancer diagnosed by Pathology and imageology;
• Tumor cannot be excised by surgery, and multiline chemotherapy, radiation, targeted therapy fails, or other treatments cannot be tolerated;
• At least one measurable lesions;
• To be able to obtain sufficient tumor tissue samples and blood samples for analysis, or to have genomic/exon/transcriptional data of tumor tissues and normal tissues, and the data meet the analysis requirements;
• The main organs function is normal, such as the heart, liver and kidney;
• Haematological index:

neutrophil count≥1.5×10e9/L hemoglobin≥10g/dL platelet count≥100×10e9/L

• Biochemical index:

Total bilirubin is less than or equal to 1.5 times the upper limit of normal value (ULN) AST and ALT is less than or equal to 2.5 times the upper limit of normal value Serum creatinine and urea nitrogen (BUN) is less than or equal to 1.5 times the upper limit of normal value

• 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;
• Good compliance, able to follow research protocols and follow-up procedures.

Exclusion Criteria:

• Diagnosed as other malignant tumor;
• There have been bone marrow or stem cell transplants;
• No neoantigen was found in the sequencing data;
• Systemic cancer treatment or other drugs under study were treated within 4 weeks prior to Individualized tumor targeted polypeptides treatment;
• 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;
• Active bacterial or fungal infections identified clinically (>= level 2 of NCI-CTC edition 3);
• Patients with HIV, HCV, HBV infection, severe asthma, autoimmune disease, immunodeficiency or treated with immunosuppressive drugs;
• Severe coronary or cerebrovascular disease, or other diseases that the investigators considered should to be exclusion;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: iNeo-Vac-P01; Personal Cancer Vaccine: iNeo-Vac-P01 (peptides)+ GM-CSF; Peptides: 4 x 100 mcg per peptide given on days 1, 4, 8, 15, 22, 78, and 162 for a total of 7 doses; GM-CSF: 4 x 40 mcg (total dose 160 mcg) given on days 1, 4, 8, 15, 22, 78, and 162 for a total of 7 doses	Biological: iNeo-Vac-P01; Neoantigen peptides; Other: GM-CSF; immune adjuvant; Other Names: granulocyte-macrophage colony stimulating factor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate	2 years
Number of participants experiencing clinical and laboratory adverse events (AEs)	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival	2 years
Overall Survival Rate	2 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.

Publications and helpful links

General Publications

• Ott PA, Hu Z, Keskin DB, Shukla SA, Sun J, Bozym DJ, Zhang W, Luoma A, Giobbie-Hurder A, Peter L, Chen C, Olive O, Carter TA, Li S, Lieb DJ, Eisenhaure T, Gjini E, Stevens J, Lane WJ, Javeri I, Nellaiappan K, Salazar AM, Daley H, Seaman M, Buchbinder EI, Yoon CH, Harden M, Lennon N, Gabriel S, Rodig SJ, Barouch DH, Aster JC, Getz G, Wucherpfennig K, Neuberg D, Ritz J, Lander ES, Fritsch EF, Hacohen N, Wu CJ. An immunogenic personal neoantigen vaccine for patients with melanoma. Nature. 2017 Jul 13;547(7662):217-221. doi: 10.1038/nature22991. Epub 2017 Jul 5. Erratum In: Nature. 2018 Mar 14;555(7696):402.
• Weden S, Klemp M, Gladhaug IP, Moller M, Eriksen JA, Gaudernack G, Buanes T. Long-term follow-up of patients with resected pancreatic cancer following vaccination against mutant K-ras. Int J Cancer. 2011 Mar 1;128(5):1120-8. doi: 10.1002/ijc.25449.
• Chen Z, Zhang S, Han N, Jiang J, Xu Y, Ma D, Lu L, Guo X, Qiu M, Huang Q, Wang H, Mo F, Chen S, Yang L. A Neoantigen-Based Peptide Vaccine for Patients With Advanced Pancreatic Cancer Refractory to Standard Treatment. Front Immunol. 2021 Aug 13;12:691605. doi: 10.3389/fimmu.2021.691605. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 24, 2017
• Primary Completion (ACTUAL): November 1, 2020
• Study Completion (ACTUAL): April 1, 2021

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (ACTUAL): August 24, 2018

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

• Keywords: Neoantigen, Pancreatic Cancer, iNeo-Vac-P01,Peptide Vaccine
• 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-001

Drug and device information, study documents

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