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DC Vaccine in Pancreatic Cancer

Primary Purpose

Pancreatic Ductal Adenocarcinoma

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

mDC3/8-KRAS Vaccine

About this trial

This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring Pancreatic Adenocarcinoma, Cancer vaccine, Dendritic cell vaccine, Mutant KRAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

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

Outcomes

Primary Outcome Measures

Safety and side effects of vaccine per CTCAE 4.0

Secondary Outcome Measures

Immune response measuring increased numbers of peptide specific T cells as calculated by the peptide-MHC multimer assay.

Disease Free Survival

Full Information

NCT ID

NCT03592888

First Posted

July 9, 2018

Last Updated

October 9, 2023

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT03592888

Brief Title

DC Vaccine in Pancreatic Cancer

Official Title

Pilot Study of Mature Dendritic Cell Vaccination Against Mutated KRAS in Patients With Resectable Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 20, 2018 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic Adenocarcinoma, Cancer vaccine, Dendritic cell vaccine, Mutant KRAS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

All subjects

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

mDC3/8-KRAS Vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

Disease Free Survival

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Abramson Cancer Center

Phone

855.216.0098

PennCancerTrials@careboxhealth.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark O'Hara, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Abramson Cancer Center

Phone

855-216-0098

PennCancerTrials@careboxhealth.com

12. IPD Sharing Statement

Learn more about this trial

DC Vaccine in Pancreatic Cancer

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