What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer include chemotherapy, targeted therapies, and immunotherapies such as dendritic cell vaccines. Chemotherapy can cause side effects like nausea, vomiting, hair loss, fatigue, and increased risk of infections. Targeted therapies may lead to diarrhea, liver problems, and skin issues. Immunotherapies, including dendritic cell vaccines, can cause immune-related side effects such as fatigue, fever, chills, and inflammation in various organs, including the lungs, liver, and intestines. It's important to discuss these potential side effects with a healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including chemotherapy agents like gemcitabine and nab-paclitaxel, as well as targeted therapies such as erlotinib. In the realm of immunotherapy, pembrolizumab, an immune checkpoint inhibitor targeting PD-1, has been approved for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), which can include pancreatic cancer. While dendritic cell vaccines specifically for pancreatic cancer are still under investigation, these approvals highlight the growing interest in leveraging the immune system to combat this challenging disease.

What other types of research exist?

Promising novel alternatives to Dendritic Cell Vaccine for pancreatic cancer patients include immune checkpoint inhibitors (such as pembrolizumab and nivolumab), chimeric antigen receptor (CAR)-T cell therapies, and oncolytic virotherapy. These therapies are being actively researched and have shown potential in enhancing the immune system's ability to target and destroy cancer cells.

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Cancer Vaccine

DC Vaccine for Pancreatic Cancer

Phase 1

Waitlist Available

Led By Mark O'Hara, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically-confirmed KRAS(G12D-), KRAS(G12V-), KRAS(G12R-) or KRAS(G12C-mutated) pancreatic ductal adenocarcinoma who are at high risk of relapse and have no evidence of disease

ECOG performance status 0-1

Must not have

Prior malignancy (except non-melanoma skin cancer) within 3 years

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through week 12

Awards & highlights

Summary

This trial is testing a vaccine made from a patient’s own white blood cells to help their immune system fight pancreatic cancer. It targets patients who have had their cancer surgically removed to prevent it from coming back. The vaccine works by teaching the immune system to recognize and attack cancer cells. The goal is to enhance the body's ability to identify and respond to cancer.

Who is the study for?

This trial is for adults with specific KRAS-mutated pancreatic cancer who are at high risk of relapse but currently show no signs of the disease. They must have certain HLA class I alleles, be in good physical condition (ECOG 0-1), and meet lab value criteria. Participants should agree to use birth control during and after the trial. Those with more than two prior chemo treatments, chronic viral infections, uncontrolled illnesses, or on systemic immunosuppressants can't join.

What is being tested?

The study is testing a dendritic cell vaccine called mDC3/8-KRAS Vaccine designed for pancreatic cancer treatment. It aims to evaluate how effective this vaccine is in preventing cancer recurrence in patients who have undergone previous treatment and are currently without detectable disease.

What are the potential side effects?

Potential side effects may include typical immune responses such as inflammation at the injection site, fever, fatigue or allergic reactions due to egg components in the vaccine formulation. Since it's an investigational product, there might be unknown risks involved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pancreatic cancer is KRAS mutated but shows no signs of the disease currently.

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I am fully active or can carry out light work.

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My genetic test shows I have HLA-A02, HLA-A03, HLA-A11, HLA-B07, or HLA-C08.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had cancer (other than non-melanoma skin cancer) in the last 3 years.

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I do not have any unmanaged ongoing illnesses.

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I have had more than two chemotherapy treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and side effects of vaccine per CTCAE 4.0

Secondary outcome measures

Disease Free Survival

Immune response measuring increased numbers of peptide specific T cells as calculated by the peptide-MHC multimer assay.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All subjectsExperimental Treatment1 Intervention

All subjects will receive the vaccine and be followed per the schedule of procedures.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mDC3/8-KRAS Vaccine

2018

Completed Phase 1

~30

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The dendritic cell vaccine for pancreatic cancer works by stimulating the patient's immune system to recognize and attack cancer cells. Dendritic cells, a type of white blood cell, are exposed to cancer antigens outside the body and then reintroduced to the patient, where they help activate T-cells to target the cancer. This approach is significant for pancreatic cancer patients as it offers a potential way to harness the body's own immune system to fight the disease, which is often resistant to conventional treatments. Other common treatments include chemotherapy, which kills rapidly dividing cells, and targeted therapies that focus on specific molecular targets associated with cancer. These treatments aim to reduce tumor size and slow disease progression, but they often come with significant side effects and varying degrees of effectiveness.

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,027 Previous Clinical Trials

42,885,682 Total Patients Enrolled

Mark O'Hara, MDPrincipal InvestigatorUniversity of Pennsylvania

3 Previous Clinical Trials

55 Total Patients Enrolled

~4 spots leftby Sep 2025

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