DC Vaccine in Pancreatic Cancer (NCT03592888) | Clinical Trial Compass
CompletedPhase 1
DC Vaccine in Pancreatic Cancer
United States29 participantsStarted 2018-11-20
Plain-language summary
This research study is designed to evaluate the effects of a dendritic cell (kind of white blood cell) vaccine for pancreatic cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Expression of one or more of the following HLA class I alleles: HLA-A02, HLA-A03, HLA-A11, HLA-B07 and HLA-C08.
* Male or female, age 18+
* ECOG performance status 0-1
* Certain required laboratory values, performed within 14 days prior to consent
* Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial.
* Provide written informed consent
Exclusion Criteria:
* Prior treatment with more than two lines of cytotoxic chemotherapy. Radiotherapy is not considered a line of therapy.
* Prior malignancy (except non-melanoma skin cancer) within 3 years.
* Pregnant or nursing women.
* Concurrent treatment with systemic immunosuppressants, including corticosteroids (e.g prednisone), calcineurin inhibitors (e.g tacrolimus, cyclosporine), antiproliferative agents (e.g mycophenolate mofetil, azathioprine) within 2 weeks of eligibility confirmation. Local (inhaled or topical) steroids or replacement dose prednisone (≤ 10 mg daily) are permitted.
* Known chronic viral infections including hepatitis B, hepatitis C, and HIV.
* Known allergy to eggs.
* Prior history of uveitis or autoimmune inflammatory eye disease.
* Uncontrolled intercurrent illness.
* Any condition that, in the opini…
What they're measuring
1
Safety and side effects of vaccine per CTCAE 4.0
Timeframe: At time of consent through 30 days after the subject's last DC vaccine