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