NCT03592888

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2018

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 20, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2024

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

5.2 years

First QC Date

July 9, 2018

Last Update Submit

June 25, 2025

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic AdenocarcinomaCancer vaccineDendritic cell vaccineMutant KRAS

Outcome Measures

Primary Outcomes (1)

  • Safety and side effects of vaccine per CTCAE 4.0

    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.

    Day 1 through week 12

  • Disease Free Survival

    30 days following second vaccine through study completion approximately 12 months after the first DC vaccine

Study Arms (1)

All subjects

EXPERIMENTAL

All subjects will receive the vaccine and be followed per the schedule of procedures.

Drug: mDC3/8-KRAS Vaccine

Interventions

mDC3/8-KRAS VaccineDRUG

Mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic adenocarcinoma

All subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 39287991DERIVED

Study Officials

  • Mark O'Hara, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 19, 2018

Study Start

November 20, 2018

Primary Completion

February 12, 2024

Study Completion

February 12, 2024

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)