Clinical trial · Interventional
DC Vaccine in Pancreatic Cancer
Pilot Study of Mature Dendritic Cell Vaccination Against Mutated KRAS in Patients With Resectable Pancreatic Cancer
NCT03592888CI-TRIAL-00091531completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study is designed to evaluate the effects of a dendritic cell (kind of white blood cell) vaccine for pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mDC3/8-KRAS Vaccine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All subjects
- description
- All subjects will receive the vaccine and be followed per the schedule of procedures.
- interventionNames
- Drug: mDC3/8-KRAS Vaccine
Primary outcomes (1)
- measure
- 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
Secondary outcomes (2)
- measure
- Immune response measuring increased numbers of peptide specific T cells as calculated by the peptide-MHC multimer assay.
- timeFrame
- Day 1 through week 12
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBear AS, Nadler RB, O'Hara MH, Stanton KL, Xu C, Saporito RJ, Rech AJ, Baroja ML, Blanchard T, Elliott MH, Ford MJ, Jones R, Patel S, Brennan A, O'Neil Z, Powell DJ Jr, Vonderheide RH, Linette GP, Carreno BM. Natural TCRs targeting KRASG12V display fine specificity and sensitivity to human solid tumors. J Clin Invest. 2024 Sep 17;134(21):e175790. doi: 10.1172/JCI175790. PMID 39287991