Vaccine + Sargramostim for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Corticosteroids, Investigational agents

Disqualifiers: Brain metastases, Uncontrolled illness, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 71 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine combined with sargramostim, a medication that boosts immune cells, to determine the best dose and identify side effects in people with advanced pancreatic cancer that cannot be surgically removed. The vaccine aims to help the immune system attack and kill cancer cells. Sargramostim may enhance the vaccine's effectiveness by increasing immune cell numbers. This trial might suit those with pancreatic cancer not removable by surgery, who do not have severe liver involvement or breathing problems. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the vaccine therapy used in this trial, when combined with sargramostim, is still under investigation for safety. Earlier studies found that patients who received similar vaccines generally did not experience severe side effects, indicating a good safety record. However, as this is an early-stage trial, the full safety details are still being explored.

Sargramostim, part of this treatment, has already been approved for other uses. Research has shown it is usually safe and well-tolerated. It strengthens the immune system by increasing certain blood cells and has a good safety record.

Overall, while the vaccines are still under study, existing research suggests that sargramostim is safe in many situations. Participants should discuss any concerns with their healthcare provider to receive personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of the falimarev and inalimarev vaccines with sargramostim for pancreatic cancer because this approach targets the immune system in a novel way. Unlike the standard treatments for pancreatic cancer, such as chemotherapy and surgery, which focus on directly attacking the tumor or removing it, this treatment uses vaccines to stimulate the body's own immune response to fight the cancer. The intratumoral administration of the falimarev vaccine, guided by endoscopic ultrasound, and the subsequent subcutaneous doses, aim to localize and enhance the immune attack on cancer cells. This method could potentially lead to improved outcomes by not only reducing tumor size but also preventing disease progression with fewer side effects.

What evidence suggests that this treatment might be an effective treatment for pancreatic cancer?

Research has shown that vaccines made from genetically modified viruses can help the immune system find and destroy cancer cells. In this trial, participants will receive a combination of the falimarev and inalimarev vaccines along with sargramostim. Early studies on mice given a similar vaccine showed they remained tumor-free for over 50 days, suggesting potential effectiveness against pancreatic cancer. Sargramostim, which encourages the production of immune cells, has enhanced the body's ability to fight cancer. Using the vaccine with sargramostim might lead to a stronger immune response, potentially increasing effectiveness against pancreatic tumors. Although human studies provide limited information, this treatment aims to boost the body's natural ability to fight cancer. ^{1 2 4 5 6}

Who Is on the Research Team?

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

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.

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?

Group I: Treatment (vaccine therapy, sargramostim) Experimental Treatment 4 Interventions

Patients receive falimarev vaccine intratumorally using endoscopic ultrasound guidance on day 1. Patients also receive inalimarev vaccine SC on day 1 and sargramostim SC on days 1-4. Patients then receive falimarev vaccine SC on days 15 and 29 and sargramostim SC on days 15-18 and 29-32 in the absence of unacceptable toxicity. Beginning on day 43, patients with stable or improving pancreatic cancer receive falimarev vaccine SC and sargramostim SC (given on the day of and for 3 days after each falimarev vaccination) monthly in the absence of disease progression or unacceptable toxicity. Beginning on day 71, patients with no irreversible or dose limiting toxicity, receive falimarev vaccine SC and sargramostim SC (given on the day of and for 3 days after each falimarev vaccination) monthly in the absence of disease progression or unacceptable toxicity.

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 Rotterdam PancrEAtic Cancer Vaccination-2 trial is investigating the safety and tolerability of a combination treatment using dendritic cell vaccines and an anti-CD40 agonistic antibody in patients with advanced pancreatic cancer, with a focus on those who have not responded to standard chemotherapy.

This phase I trial will include 12 to 18 patients and aims to assess treatment-induced immune responses and tumor-specific effects, potentially offering a new immunotherapy approach for a disease with limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Lau, SP., van 't Land, FR., van der Burg, SH., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trials of vaccines for pancreatic ductal adenocarcinoma: Is there any hope of an improved prognosis? Mizuguchi, T., Torigoe, T., Satomi, F., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00669734?locStr=United+States&country=United+States&aggFilters=status%3A

Vaccine Therapy and Sargramostim in Treating Patients ... Beginning on day 43, patients with stable or improving pancreatic cancer receive falimarev vaccine SC and sargramostim SC (given on the day of and for 3 days ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3899139/

Clinical evaluation of therapeutic cancer vaccines - PMC Provenge® is the only therapeutic cancer vaccine to be approved based on phase IIIb data, which demonstrated significant efficacy of Provenge® with regard to ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.673

Pamrevlumab plus nab-paclitaxel/gemcitabine (Pam + GA) ... Pamrevlumab plus nab-paclitaxel/gemcitabine (Pam + GA) as first- and second-line therapy in metastatic pancreatic cancer (mPDAC): Results from ...

4. withpower.com withpower.com/trial/phase-1-adenocarcinoma-1-2010-b700c

Vaccine + Sargramostim for Pancreatic Cancer 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12195586/

A Systematic Review of Immunotherapy in Multimodal Treatment Improving outcomes in pancreatic adenocarcinoma: a systematic review of immunotherapy in multimodal treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8901600/

Advanced Pancreatic Cancer Patient Benefit From ... We recently conducted a clinical study that combined neoantigen nanovaccine with anti-PD-1 antibody. Here, we reported a case with a clear beneficial outcome ...