Cancer Vaccine for Pancreatic Cancer

Overseen By Carol A Judkins, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Systemic steroids

Disqualifiers: Autoimmune diseases, Uncontrolled medical problems, Others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months between vaccines

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer vaccine for individuals who have undergone surgery for pancreatic cancer. The goal is to determine if the vaccine, alone or with cyclophosphamide, is safe and effective in preventing cancer recurrence. Participants may receive the vaccine alone or with either a single dose or daily doses of cyclophosphamide. Those who have had surgery for pancreatic cancer and completed chemotherapy may qualify. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cancer care.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had systemic steroid therapy within 28 days before or after the vaccine administration.

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

Research has shown that the GVAX Pancreas Vaccine, which uses specially prepared pancreatic cancer cells, has generally been well-tolerated in past studies. It can help the body's immune system fight cancer cells. Researchers are testing this vaccine both alone and with cyclophosphamide, a drug that can boost the immune response.

Studies have found that this combination can strengthen the body's ability to fight tumors. While some side effects, such as fever and tiredness, have been reported, they are usually mild. It is important to note that earlier studies have tested this vaccine with cyclophosphamide, suggesting it is reasonably safe.

Although this treatment is still under study, its presence in a later phase of trials indicates it has passed initial safety checks. This is promising for those considering participation in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these cancer vaccines for pancreatic cancer because they represent a novel approach to treatment. Unlike traditional treatments like chemotherapy or surgery, which directly target cancer cells or tumors, these vaccines aim to stimulate the body's immune system to recognize and attack cancer cells more effectively. The vaccines use a combination of genetically modified DNA and immune-stimulating agents like GM-CSF to enhance this immune response. This approach could potentially offer a more targeted and less toxic treatment option compared to conventional therapies.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research shows that the GVAX Pancreas Vaccine, used in this trial, helps the body's immune system fight cancer cells. Early results suggest that this vaccine strengthens the body's response against tumors, making it easier for the immune system to find and attack cancer cells. Some studies have found that patients receiving similar vaccines lived longer than those who did not. However, past trials in advanced pancreatic cancer have shown mixed results, with some demonstrating limited success. In this trial, participants in various treatment arms will receive the vaccine, with some arms also including cyclophosphamide, a chemotherapy drug, in the hope that this combination may more effectively treat pancreatic cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Daniel Laheru, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals who've had surgery to remove stage I or II pancreatic cancer and have completed any additional therapies at least 28 days ago. They should be in good physical condition (ECOG status of 0 or 1) with proper kidney, blood, and liver function. Women must agree to use birth control if they can have children. People with recurrent pancreatic cancer, uncontrolled health issues, recent steroid therapy, pregnancy, active infections, autoimmune diseases or other cancers within the last five years cannot join.

Inclusion Criteria

For Cohorts 1, 3, 4 and 5: Have been a participant in Hopkins IRB protocol J0810, J1568, J15237 or J1766.

Has provided informed consent.

I received a specific pancreatic cancer vaccine 6-12 months ago.

Exclusion Criteria

I do not have any uncontrolled medical issues.

I have taken steroids in the last 28 days.

Is pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive boost vaccinations of a lethally irradiated, allogeneic pancreatic tumor cell vaccine transfected with the GM-CSF gene, alone or in combination with cyclophosphamide

6 months between vaccines

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 years

What Are the Treatments Tested in This Trial?

Interventions

• PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine

Trial Overview

The study tests boost vaccinations using a genetically modified pancreatic tumor cell vaccine either alone or combined with cyclophosphamide (a chemotherapy drug). The goal is to see if these vaccines are safe and workable as long-term treatments for patients who've had certain types of pancreas surgeries.

How Is the Trial Designed?

Group I: Cohort 5 (J1766) Experimental Treatment 2 Interventions

Patients coming from J1766 (NCT03153410). Patients receive IV CY and GVAX.

Group II: Cohort 4 (J15237) Experimental Treatment 2 Interventions

Patients coming from J15237 (NCT02648282). Patients receive IV CY and GVAX.

Group III: Cohort 3 (J1568) Experimental Treatment 2 Interventions

Patients coming from J1568 (NCT02451982). Patients receive IV CY and GVAX.

Group IV: Cohort 2 (Vaccine Naive) Experimental Treatment 2 Interventions

Patients receive IV CY and GVAX.

Group V: Cohort 1 (J0810 Arm C) Experimental Treatment 2 Interventions

Patients coming from J0810 (NCT00727441). Patients receive oral CY and GVAX.

Group VI: Cohort 1 (J0810 Arm B) Experimental Treatment 2 Interventions

Patients coming from J0810 (NCT00727441). Patients receive IV CY and GVAX.

Group VII: Cohort 1 (J0810 Arm A) Experimental Treatment 1 Intervention

Patients coming from J0810 (NCT00727441). Patients receive GVAX.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

The Skip Viragh Foundation

Collaborator

Trials

4

Recruited

170+

Published Research Related to This Trial

The neoantigen-targeted vaccine PancVAX, developed using whole-exome and RNA sequencing, effectively activated T cells against pancreatic cancer in mice, leading to temporary tumor regression.

When combined with checkpoint modulators (anti-PD-1 and OX40 antibodies), PancVAX not only enhanced tumor regression but also promoted T cell memory, suggesting a potential for long-lasting immunity against tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining STING-based neoantigen-targeted vaccine with checkpoint modulators enhances antitumor immunity in murine pancreatic cancer. Kinkead, HL., Hopkins, A., Lutz, E., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06782932

NCT06782932 | Comparing Neoadjuvant/Adjuvant GVAX ...

The purpose of this study is to determine the optimal dose of AGEN2373 that is safe when given in combination with balstilimab and Pancreatic GVAX Whole ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12293625/

Cancer Vaccination and Immune-Based Approaches in ...

In contrast, in advanced pancreatic cancer, disease progression is often inevitable, and vaccine trials in PDAC have generally shown little success [14,16,20,36 ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02243371

Study Details | NCT02243371 | GVAX Pancreas Vaccine ...

The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with ...

4.

trial.medpath.com

trial.medpath.com/clinical-trial/7dfdc9de66fe7608/safety-feasibility-trial-boost-vaccinations-pancreatic-tumor-vaccine

Boost GVAX Pancreas Vaccine With or Without CY in Patients ...

The purpose of this study is to evaluate the safety and feasibility of long term boost vaccination of a lethally irradiated, allogenic pancreatic tumor cell ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7023714/

Current advances and outlooks in immunotherapy for ...

PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine, Cyclophophamide, radiation, FOLFIRINOX, Increase the antitumour cellular response, Not ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01088789

Boost GVAX Pancreas Vaccine With or Without CY in ...

The purpose of this study is to evaluate the safety and feasibility of long term boost vaccination of a lethally irradiated, allogenic pancreatic tumor cell ...

7.

journals.sagepub.com

journals.sagepub.com/doi/10.1089/hum.2022.210?icid=int.sj-abstract.similar-articles.4

Pancreatic Cancer Cell and Gene Biotherapies: Past, Present ...

Another version of the GVAX vaccine uses, this time, allogeneic irradiated pancreatic cells transfected with a plasmid encoding GM-CSF (PANC 10.05 pcDNA-1/GM- ...