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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through week 12

Awards & highlights

Study Summary

This trialtests a vaccine to help fight pancreatic cancer, using dendritic cells from the patient's own body.

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.Check my eligibility

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.See study design

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.

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,002 Previous Clinical Trials

42,880,970 Total Patients Enrolled

Mark O'Hara, MDPrincipal InvestigatorUniversity of Pennsylvania

3 Previous Clinical Trials

55 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities for this experiment available at the current time?

"Based on the information provided through clinicaltrials.gov, this trial is open for recruitment. Its initial posting was made on November 20th 2018 and it has received an update as recently as October 6th 2022."

Answered by AI

How many individuals are actively engaged in this research project?

"Affirmative. The data on clinicaltrials.gov reveals that this clinical trial is actively enrolling participants - it was initially posted on November 20th 2018 and the most recent update occurred October 6th 2022. This study requires 12 patients to be enrolled at 1 medical facility."

Answered by AI

Is the mDC3/8-KRAS Vaccine sanctioned by the FDA?

"Our expert panel at Power assigned mDC3/8-KRAS Vaccine a score of 1, given that it is currently undergoing Phase 1 trials which involve small sample sizes and limited evidence regarding safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DC Vaccine in Pancreatic Cancer

2018. "DC Vaccine in Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03592888.