18 Participants Needed

Vaccine + Sargramostim for Pancreatic Cancer

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of vaccine therapy when given together with sargramostim in treating patients with locally advanced or metastatic pancreatic cancer that cannot be removed by surgery. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy directly into the tumor together with sargramostim may cause a stronger immune response and kill more tumor cells.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had chemotherapy or radiotherapy within 4 weeks before starting the study. Also, you cannot be on systemic corticosteroid therapy within 28 days of registration.

How does the treatment Vaccine + Sargramostim for Pancreatic Cancer differ from other treatments?

This treatment is unique because it combines a vaccine with Sargramostim, which is a growth factor that stimulates the immune system, potentially enhancing the body's ability to fight pancreatic cancer. Unlike standard treatments, this approach aims to break the tumor's immune evasion by boosting T-cell responses, which are crucial for targeting and destroying cancer cells.12345

What data supports the effectiveness of the treatment Vaccine + Sargramostim for Pancreatic Cancer?

While there is no direct evidence of effectiveness for this specific treatment combination, similar vaccine approaches have shown promise. For example, a personalized mRNA vaccine led to immune responses and delayed disease recurrence in some pancreatic cancer patients, suggesting potential for vaccine-based therapies.23467

Who Is on the Research Team?

EA

Elizabeth Poplin, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

This trial is for patients with advanced pancreatic cancer that can't be surgically removed. They should have a life expectancy of at least 6 months, good physical function, and adequate organ function. Participants must not have other serious illnesses or conditions that could interfere with the study, no recent chemotherapy or radiotherapy, no brain metastases, and they must agree to use contraception.

Inclusion Criteria

My pancreatic cancer cannot be surgically removed, but it can be treated with an ultrasound-guided injection.
I will use birth control during and for four months after the study.
Patients (in the opinion of the principal investigator) should be able to complete a full 3-month course of vaccination preferably with an anticipated survival of 6 months or longer
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Exclusion Criteria

I am currently experiencing symptoms of pancreatitis with high amylase or lipase levels.
I do not have HIV, hepatitis B, or hepatitis C.
I can avoid close contact with high-risk individuals for 3 weeks after getting the PANVAC-V vaccine.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive falimarev vaccine intratumorally and inalimarev vaccine subcutaneously, along with sargramostim, with a dose-escalation study design

71 days
Multiple visits for vaccine administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months

Long-term monitoring

Participants are monitored for T cell proliferation and cytokine production

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

  • Falimarev
  • Inalimarev
  • Sargramostim
Trial Overview The trial is testing vaccine therapy using gene-modified viruses alongside sargramostim (a substance boosting white blood cells) to see if this combination prompts the body's immune system to destroy cancer cells more effectively. The vaccines are injected directly into the tumor.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (vaccine therapy, sargramostim)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Pancreatic tumors are highly resistant to chemotherapy and are often diagnosed at advanced stages, leading to limited treatment options for patients.
Despite decades of research into vaccine therapies for pancreatic cancer, recent reviews indicate that none have successfully improved clinical outcomes, highlighting the ongoing challenges in developing effective treatments.
Trials of vaccines for pancreatic ductal adenocarcinoma: Is there any hope of an improved prognosis?Mizuguchi, T., Torigoe, T., Satomi, F., et al.[2023]
In a study of 7 patients with advanced pancreatic ductal adenocarcinoma (PDA) receiving a WT1-targeting dendritic cell vaccine combined with chemotherapy, those who responded well (super-responders) had significantly lower levels of plasma matrix metalloproteinase-9 and systemic inflammatory markers compared to non-responders.
Lower cytoplasmic expression of WT1 in PDA cells was also associated with better overall survival, suggesting that both low inflammatory responses and low WT1 expression may serve as predictive markers for patient outcomes in this treatment approach.
Predicted Markers of Overall Survival in Pancreatic Cancer Patients Receiving Dendritic Cell Vaccinations Targeting WT1.Ito, Z., Kan, S., Bito, T., et al.[2019]
The dendritic cell (DC) vaccine modified with tumor lysate and Interleukin-18 (IL-18) significantly enhanced immune responses in a mouse model of pancreatic carcinoma, leading to higher levels of IL-18 and IFN-gamma compared to other treatment groups.
Mice treated with the DC-IL18-Lysate vaccine remained tumor-free for at least 50 days and had a median survival of over 62 days, which was significantly longer than other groups, indicating its potential efficacy as a therapeutic vaccine against pancreatic cancer.
The immunotherapeutic effect of dendritic cells vaccine modified with interleukin-18 gene and tumor cell lysate on mice with pancreatic carcinoma.Tang, ZH., Qiu, WH., Wu, GS., et al.[2019]

Citations

Trials of vaccines for pancreatic ductal adenocarcinoma: Is there any hope of an improved prognosis? [2023]
Predicted Markers of Overall Survival in Pancreatic Cancer Patients Receiving Dendritic Cell Vaccinations Targeting WT1. [2019]
The immunotherapeutic effect of dendritic cells vaccine modified with interleukin-18 gene and tumor cell lysate on mice with pancreatic carcinoma. [2019]
Safety and tumour-specific immunological responses of combined dendritic cell vaccination and anti-CD40 agonistic antibody treatment for patients with metastatic pancreatic cancer: protocol for a phase I, open-label, single-arm, dose-escalation study (REACtiVe-2 trial). [2023]
Personalized mRNA Vaccine Immunogenic against PDAC. [2023]
Gastrin vaccine improves response to immune checkpoint antibody in murine pancreatic cancer by altering the tumor microenvironment. [2020]
An ISCOM vaccine combined with a TLR9 agonist breaks immune evasion mediated by regulatory T cells in an orthotopic model of pancreatic carcinoma. [2020]
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