Neoantigen Vaccine for Advanced Cancer

Enrolling by invitation at 4 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jaime Leandro Foundation for Therapeutic Cancer Vaccines

Must be taking: Folfirinox

Must not be taking: Immunosuppressive therapies

Disqualifiers: Immunodeficiency, Autoimmune, Psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a personalized vaccine designed to help the immune system target and fight cancer cells in individuals with solid tumors, whether localized or metastatic. The main goal is to determine the vaccine's safety and its effectiveness in reducing cancer growth. As a single-arm study, all participants receive the experimental vaccine. Suitable candidates for this trial include individuals with pancreatic cancer already undergoing certain treatments, recently diagnosed glioblastoma patients, or those with other cancers that have limited treatment options and lower survival chances. 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 vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that interfere with the vaccine or are immunosuppressive, you may need to adjust them. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that personalized vaccines made from synthetic long peptides are under study for their safety in cancer treatment. Previous studies have found these vaccines to be generally well-tolerated by patients with solid tumors. For example, some trials demonstrated that the vaccines can safely activate the immune system to combat cancer cells.

In one study, the vaccine was tested on patients with head and neck cancer and proved safe and effective in generating an immune response. Another research effort focused on ensuring these vaccines can be used safely, highlighting their potential to treat cancer without major side effects.

While these results are promising, the vaccine remains under testing. More research is needed to fully understand its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced cancer, which often include chemotherapy, radiation, or targeted therapies, the personalized synthetic long peptide vaccine is unique because it harnesses the body's own immune system to fight cancer. This vaccine is custom-made for each patient, targeting specific neoantigens—unique markers on cancer cells that arise from mutations. Researchers are excited about this treatment because it has the potential to provide a highly targeted attack on cancer cells, potentially reducing side effects and improving effectiveness compared to more generalized therapies.

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

Research shows that personalized vaccines made from synthetic long peptides may help treat cancer. In a study with melanoma patients, these vaccines led to positive results, suggesting they can help the immune system attack cancer cells. By targeting neoantigens—unique markers on cancer cells—these vaccines trigger an immune response. Other studies have found that these vaccines can create strong immune responses against solid tumors. Although more information is needed, early results are promising for patients with advanced or spreading cancers. Participants in this trial will receive the Personalized Synthetic Long Peptide Vaccine to evaluate its effectiveness in treating advanced cancer. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that have worsened after standard treatments, or when no effective standard treatment exists, or if they can't receive standard therapy. They should be in a condition where their survival chance is below 50% over the next five years and must not have severe allergies to vaccines or ingredients in the study vaccine.

Inclusion Criteria

Ability to understand and willingness to sign an IRB approved written informed consent document

My advanced cancer has low survival odds and has not responded to standard treatments.

My doctor believes my organs are functioning well enough for treatment.

Exclusion Criteria

History of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty or known allergy to a component of the neoantigen synthetic long peptide vaccine

I will use birth control or abstain from sex during and for 3 months after the study.

Psychiatric illness or social situations that would limit compliance with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Neoantigen Synthetic Long Peptide Vaccines

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Synthetic Long Peptide Vaccine

Trial Overview The trial is testing personalized synthetic long peptide vaccines designed for each patient's unique tumor makeup. Up to 20 participants will receive these custom-made vaccines aimed at treating various advanced cancers.

How Is the Trial Designed?

Group I: Personalized Synthetic Long Peptide Vaccine Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Jaime Leandro Foundation for Therapeutic Cancer Vaccines

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

The personalized neoantigen-based vaccine NEO-PV-01, combined with PD-1 blockade, was found to be safe in a phase Ib trial involving 82 patients with advanced melanoma, lung, or bladder cancer, with no serious treatment-related adverse events reported.

The vaccine successfully induced strong CD4+ and CD8+ T cell responses, which not only targeted the specific neoantigens but also led to an immune response against additional neoantigens, indicating a broadening of the immune attack on the tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer. Ott, PA., Hu-Lieskovan, S., Chmielowski, B., et al.[2023]

Personalized neoantigen vaccines are a promising new approach in cancer immunotherapy, designed to stimulate T cell responses specifically against tumor-specific neoantigens unique to individual patients.

Initial clinical studies have shown that these vaccines can generate strong immune responses and exhibit preliminary antitumor activity, particularly in melanoma and other cancers, thanks to advancements in sequencing and bioinformatics technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the development of personalized neoantigen-based therapeutic cancer vaccines. Blass, E., Ott, PA.[2023]

A phase 1B study demonstrated that a personalized neoantigen vaccine combined with PD-1 blockade can stimulate strong T cell responses in patients with advanced cancers.

This combination therapy shows potential for enhancing tumor destruction and improving clinical outcomes, suggesting a promising approach for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Personalized Neoantigens Raise the T Cell Bar? Zaidi, N.[2022]

Neoantigen vaccines, particularly those using long synthetic peptides derived from tumor mutations, show promise in improving tumor-specificity and reducing side effects compared to traditional cancer vaccines.

These long peptides can potentially enhance immune responses by overcoming immune tolerance, leading to activation of both CD4+ and CD8+ T cells, which are crucial for effective cancer immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized neoantigen vaccination with synthetic long peptides: recent advances and future perspectives. Chen, X., Yang, J., Wang, L., et al.[2021]

A personalized neoantigen nanovaccine combined with anti-PD-1 antibody treatment led to a significant clinical benefit in an advanced pancreatic cancer patient, resulting in an overall survival of 10.5 months after treatment.

The treatment successfully induced a robust T cell response against multiple vaccine peptides, indicating that this approach may effectively enhance immune responses in controlling progressive metastatic pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced Pancreatic Cancer Patient Benefit From Personalized Neoantigen Nanovaccine Based Immunotherapy: A Case Report. Shao, J., Liu, Q., Shen, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7255011/

Personalized neoantigen vaccination with synthetic long ... In 2017, the first clinical trial of long peptide-based neoantigen vaccines reported encouraging outcomes in melanoma patients. Subsequent clinical trials ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07002203

Personalized Neoantigen Peptide Vaccines for Solid Tumors This clinical trial is studying the safety and efficacy of a personalized cancer vaccine called a neoantigen peptide vaccine in patients with solid tumors.

3. nature.com nature.com/articles/s41586-024-08507-5

A neoantigen vaccine generates antitumour immunity in ... Personalized cancer vaccines (PCVs) can generate circulating immune responses against predicted neoantigens1,2,3,4,5,6.

4. cancerbiomed.org cancerbiomed.org/content/21/4/274

Neoantigen cancer vaccines: a new star on the horizon Neoantigen-targeted ACT offers the potential for improved treatment outcomes and long-term survival for patients with advanced or refractory ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0092867425006853

A multi-adjuvant personal neoantigen vaccine generates ... Personalized neoantigen-targeting vaccines have demonstrated great promise; however, improved immunogenicity is still needed. Since antigen availability and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11949952/

Advancements and challenges in personalized neoantigen ... TG4050, a personalized cancer vaccine using a viral vector, reported from a phase I trial, demonstrated immunogenicity and safety in treating head and neck ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02427581

Safety and Immunogenicity of a Personalized Synthetic ... The most important consideration in the design of this clinical trial is to ensure the safe translation of the personalized synthetic long peptide vaccine ...