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The schedule for vaccination will be Days 1, 4, 8, 15, and 22 (delays of up to 96 hours are allowed for each dose based on the adverse events experienced). Additional vaccinations will be given on Days 50 and 78 (+/- 2 weeks). The first vaccine dose may be administered following confirmation of disease-free status and within 90 days following date of repeat imaging. All study injections will be given subcutaneously and co-administered with poly-ICLC by a trained healthcare provider.

• Each pool of vaccine study drug + poly IC:LC will be administered to one of the four limbs (A - Right Arm, B - Left Arm, C - Right Leg, D - Left Leg) by subcutaneous (SC) injection.

Neoantigen Peptide Vaccine

-Baseline, day 1, day 22, day 50, day 78, week 25, and week 73

Blood for immune monitoring

William E Gillanders, M.D.

This is a phase 1 open-label study to evaluate the safety and immunogenicity of a neoantigen peptide vaccine strategy in pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The neoantigen peptide vaccines will incorporate prioritized neoantigens and personalized mesothelin epitopes and will be co-administered with poly-ICLC. The hypothesis of this study is that neoantigen peptide vaccines will be safe and capable of generating measurable neoantigen-specific CD4 and CD8 T cell responses.

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

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy

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

-The ELISPOT analysis is based on measuring the frequencies of IFN-γ producing T cells in response to polyepitope antigen

-The multiparametric flow cytometry assesses phenotypic as well as functional characteristics of epitope-specific T cells.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Washington University School of Medicine

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

William Gillanders, M.D.

Grade 3 ascites

Grade 3 anemia

2 participants were not evaluable for this outcome measure as they did not start vaccine treatment.

Safety of Neoantigen Peptide Vaccine as Measured by the Number of Serious Adverse Events

Immunogenicity of the Neoantigen Peptide Vaccine as Measured by ELISPOT Analysis

Immunogenicity of the Neoantigen Peptide Vaccine as Measured by Multiparametric Flow Cytometry

Overall Study

Symptoms and General Pathology

Disease Progression

Patients assigned to the neoantigen peptide vaccine/neoantigen-based DC treatment group will receive 5-6 subcutaneous injections of neoantigen peptide vaccine or neoantigen-based DC immune preparation within a 14-week treatment period.

Personalized tumor neoantigen peptide vaccine

Neoantigen peptide vaccine

Personalized tumor neoantigen DC therapeutic immune preparation

Neoantigen-based DC immune preparation

Sujun Li, PhD

Aiping Le

In this study, the investigators provide a personalized tumor neoantigen peptide vaccine/neoantigen-based DC treatment to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the neoantigen-based DC treatment.

This study is conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials.

20 patients with primary or metastatic melanoma, gastrointestinal tumor, breast cancer, cervical cancer, pancreatic cancer, lung cancer, or other malignant tumors will be recruited in this study. With doctor's assessment, a personalized tumor neoantigen peptide vaccine or neoantigen-based DC treatment plan will be designed for each participant：

1. Collecting venous blood samples;
2. Blood PBMC exome sequencing;
3. RNA transcriptome sequencing;
4. Classifying HLA alleles;
5. Performing bioinformatics analysis, finding meaningful mutations and about 10 neoantigen sequences for each patient;
6. Synthesizing peptide neoantigens;
7. Preparation of the personalized tumor neoantigen peptide vaccine or generating the personalized tumor neoantigen DC therapeutic immune preparation.

Participants will receive 5-6 subcutaneous injections of the vaccine or DC preparation within a treatment period of 14 weeks. After treatment, participants will have 3 follow-up visits during 9-months. Venous blood collection, physical examination, ECOG Performance Status Scale assessment, CT/MRI scan, X-ray examination, laboratory examination, and other necessary examinations are required at each follow-up visit.

Using Neoantigen Peptide Vaccine/Neoantigen-based DC to Treat Advanced Malignant Solid Tumors

A Clinical Study of Personalized Tumor Neoantigen Peptide Vaccine/Neoantigen-based Dendritic Cells in the Treatment of Advanced Malignant Solid Tumors

Progression-free survival (PFS) is the time from the inoculation of the individualized neoantigen immune preparation to disease progression or death from various causes for all patients. Tumor assessment is performed according to the RECIST1.1 standard. The analysis of this indicator includes results of tumor assessments performed during the treatment period and the follow-up period. If a patient has several indicators that can be judged as disease progression (PD), the indicator that appears first will be used for PFS analysis. Relapse, new tumors, or death are considered to have reached the end of the study. For patients who had not experienced disease progression at the end of the study, the last time the patient had no disease progression was used as censoring data.

Overall response rate is the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including complete response (CR) and partial response (PR) cases. Response Evaluation Criteria in Solid Tumors (RECIST 1.1) was used to evaluate the objective response of tumors. Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation is divided into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).

Overall survival is the time from inoculation of the individualized neoantigen immune preparation to death due to various causes for all patients.

Disease control rate is the percentage of patients who have a complete response (CR), partial response (PR), and stable disease (SD) to the treatment.

Changes in peripheral blood cytokines after treatment, including IFN-γ, TNF, IL-2, etc.

Eastern Cooperative Oncology Group (ECOG) Performance Status Scale. This scale describes patients' level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Researchers worldwide consider the ECOG Performance Status Scale when planning cancer clinical trials to study new treatments. There are 6 grades in ECOG, the minimum value is 0 and the maximum value is 5, while a higher score indicates a worse condition.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy	NCT03956056	Pancreas Cancer Pancreatic Canc... Cancer of the P...	Neoantigen Pept... Poly ICLC Blood for immun...	18 Years -	Washington University School of Medicine
Using Neoantigen Peptide Vaccine/Neoantigen-based DC to Treat Advanced Malignant Solid Tumors	NCT05749627	Advanced Malign...	Neoantigen pept... Neoantigen-base...	18 Years - 70 Years	The First Affiliated Hospital of Nanchang University

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