DC Vaccine in Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study is designed to evaluate the effects of a dendritic cell (kind of white blood cell) vaccine for pancreatic cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Vaccines

Criteria

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 opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.