Pancreatic Ductal AdenocarcinomaPhase 1NCT03592888
DC Vaccine in Pancreatic Cancer
A Phase 1 study testing mDC3/8-KRAS Vaccine in people with Pancreatic Ductal Adenocarcinoma, run by University of Pennsylvania at 1 site in United States.
Trial summary
This research study is designed to evaluate the effects of a dendritic cell (kind of white blood cell) vaccine for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- mDC3/8-KRAS Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2018to 12 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Pilot Study of Mature Dendritic Cell Vaccination Against Mutated KRAS in Patients With Resectable Pancreatic Cancer
This research study is designed to evaluate the effects of a dendritic cell (kind of white blood cell) vaccine for pancreatic cancer.
Read the detailed description
This is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic adenocarcinoma.
Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. Each study subject will receive cyclophosphamide 300mg/m^2 intravenously 3 to 4 days prior to the vaccine dose to deplete regulatory T cells. For each vaccine dose, all subjects will receive autologous dendritic cells pulsed with mutant KRAS peptides corresponding to the subject's specific tumor mutation and human leukocyte antigen type. On Day 1, the subject will receive the primer vaccine dose; this will be followed by one booster vaccine dose approximately 8 weeks later. Peripheral blood will be taken weekly, and a second apheresis procedure will be performed at the end of study to monitor the immune response to the vaccine. Information will be gathered from usual clinic visits for approximately 1 year following the End of Treatment Study Visit to evaluate for disease recurrence.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- mDC3/8-KRAS Vaccine
- Keywords
- Pancreatic Adenocarcinoma, Cancer vaccine, Dendritic cell vaccine, Mutant KRAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mDC3/8-KRAS VaccineDrug
Mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic adenocarcinoma
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | All subjects will receive the vaccine and be followed per the schedule of procedures. Receives: Drug: mDC3/8-KRAS Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and side effects of vaccine per CTCAE 4.0
Measured: At time of consent through 30 days after the subject's last DC vaccine
Secondary outcomes (2)
Immune response measuring increased numbers of peptide specific T cells as calculated by the peptide-MHC multimer assay.
Measured: Day 1 through week 12
Disease Free Survival
Measured: 30 days following second vaccine through study completion approximately 12 months after the first DC vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start20 Nov 2018
- Primary completion12 Feb 2024
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark O'Hara, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592888
- Sponsor's protocol ID
- UPCC 04218
- Status last verified
- Jun 2025
- First submitted
- 9 Jul 2018
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bear 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.
PubMed 39287991
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Mature Dendritic Cell Vaccination Against Mutated KRAS in Patients With Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03592888
- Acronym / sponsor ID
- UPCC 04218
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Pancreatic Adenocarcinoma, Cancer vaccine, Dendritic cell vaccine, Mutant KRAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is designed to evaluate the effects of a dendritic cell (kind of white blood cell) vaccine for pancreatic cancer.
Detailed description
This is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic adenocarcinoma.
Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. Each study subject will receive cyclophosphamide 300mg/m^2 intravenously 3 to 4 days prior to the vaccine dose to deplete regulatory T cells. For each vaccine dose, all subjects will receive autologous dendritic cells pulsed with mutant KRAS peptides corresponding to the subject's specific tumor mutation and human leukocyte antigen type. On Day 1, the subject will receive the primer vaccine dose; this will be followed by one booster vaccine dose approximately 8 weeks later. Peripheral blood will be taken weekly, and a second apheresis procedure will be performed at the end of study to monitor the immune response to the vaccine. Information will be gathered from usual clinic visits for approximately 1 year following the End of Treatment Study Visit to evaluate for disease recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Drug: mDC3/8-KRAS VaccineAll subjects will receive the vaccine and be followed per the schedule of procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mDC3/8-KRAS VaccineMature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic adenocarcinoma | Drug | All subjects |
Primary outcome
Safety and side effects of vaccine per CTCAE 4.0
Time frame: At time of consent through 30 days after the subject's last DC vaccine
2 secondary outcomes
Immune response measuring increased numbers of peptide specific T cells as calculated by the peptide-MHC multimer assay.
Time frame: Day 1 through week 12
Disease Free Survival
Time frame: 30 days following second vaccine through study completion approximately 12 months after the first DC vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Derived from this study: PubMed 39287991Bear 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark O'Hara, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mDC3/8-KRAS Vaccine in people with Pancreatic Ductal Adenocarcinoma, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and side effects of vaccine per CTCAE 4.0 (time frame: At time of consent through 30 days after the subject's last DC vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03592888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.