What side effects are associated with this type of intervention?

Common side effects of immunotherapies and cancer vaccines, such as those similar to the TLPO Cancer Vaccine, include immune-related adverse events. These can manifest as skin reactions (e.g., rash, pruritus), gastrointestinal issues (e.g., diarrhea, colitis), endocrine disorders (e.g., thyroid dysfunction, adrenal insufficiency), and respiratory problems (e.g., pneumonitis). Other potential side effects include fatigue, fever, and infusion-related reactions. The severity of these side effects can vary, with some being mild and manageable, while others may require more intensive treatment or discontinuation of therapy.

What prior FDA approvals exist?

The FDA has approved several immunotherapies that stimulate the immune system to recognize and attack cancer cells. Notable approvals include sipuleucel-T (Provenge) for metastatic castration-resistant prostate cancer, which showed improved overall survival despite minimal disease regression. Immune checkpoint inhibitors such as ipilimumab (Yervoy) for metastatic melanoma and pembrolizumab (Keytruda) for various cancers, including melanoma and non-small cell lung cancer, have also been approved. These treatments work by enhancing the body's immune response against cancer cells, similar to the investigational TLPO Cancer Vaccine.

What other types of research exist?

Promising novel alternatives to the TLPO Cancer Vaccine for cancer patients include: 1) Chimeric HBcAg virus-like particles presenting HPV 16 E7 epitope, which have shown significant tumor suppression in preclinical models. 2) Gold Glyconanoparticles combined with the 91-99 peptide of Listeriolysin O, which have demonstrated reduced tumor burden and stimulated systemic Th1-type immune responses in experimental models. 3) Neoadjuvant immunotherapy, particularly combination immunotherapy, which has shown high pathologic response rates and improved recurrence-free and distant metastasis-free survival in melanoma patients. 4) Checkpoint inhibitors such as nivolumab and pembrolizumab, which have shown durable responses and improved overall survival in various cancers.

← Back to Search

Cancer Vaccine

TLPO Vaccine for Cancer

Phase 2

Recruiting

Research Sponsored by Elios Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be ≥18 years of age

Patient must have a site of disease with planned incisional or excisional procedure expected to result in sufficient tissue for vaccine creation, or must be amenable to biopsy and be a candidate for tumor biopsy with anticipated sufficient tumor tissue resulting to vaccine creation

Must not have

Rapidly progressive disease or visceral crisis

Patient has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem-cell transplantation, at any time

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new cancer vaccine made from a patient's own tumor cells. It targets patients with solid tumors and aims to help their immune system fight the cancer. The vaccine works by teaching the immune system to recognize and attack cancer cells.

Who is the study for?

This trial is for individuals with various types of solid tumor cancers, including those that have spread (metastasized). Participants must meet certain health standards but specific inclusion criteria are not listed. People who do not meet the study's requirements or have conditions that might interfere with the vaccine's effects will be excluded.

What is being tested?

The TLPO vaccine, made from a patient's own tumor cells, is being tested to see if it can slow down cancer progression or recurrence and improve survival rates. The study also evaluates safety based on standard criteria and checks whether the vaccine triggers an immune response against cancer.

What are the potential side effects?

While specific side effects are not detailed here, they will be monitored using standardized adverse event criteria. Side effects could range from mild injection site reactions to more significant immune-related responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I can undergo a procedure to provide enough tissue for a cancer vaccine.

Select...

I am fully active or can carry out light work.

Select...

I do not have any severe health issues that are not under control.

Select...

I do not have any current infections.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer is quickly getting worse.

Select...

I have had or am expected to have an organ or stem-cell transplant.

Select...

I have been diagnosed with an immune system disorder.

Select...

I haven't had serious heart or stroke issues in the last 6 months.

Select...

I do not have any significant infections, including Hepatitis or HIV.

Select...

I haven't taken steroids, immunosuppressants, or chemotherapy in the last 30 days.

Select...

I need assistance with my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Disease Progression

Secondary study objectives

Number of participants with treatment-related adverse events per CTCAE v5.0

Overall survival (OS) after vaccination

Other study objectives

Disease Control Rate

Duration of Response

Immune Response after vaccination

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment - Investigational ProductExperimental Treatment1 Intervention

Product Name: Tumor lysate, particle only (TLPO) vaccine Dosage Form: Intradermal Injection Unit Dose: 1x10\^8 autologous tumor lysate-loaded, yeast cell wall particles Route of Administration: Intradermal; primary vaccine series at 0, 1, 2 months followed by boosters at 6, 9, and 12 months Physical Description: 250 uL clear liquid vials Manufacturer: Elios Therapeutics, LLC

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells but also affects healthy cells, leading to significant side effects. Targeted therapy aims at specific molecules involved in cancer growth and progression, offering more precision and potentially fewer side effects. Immunotherapy, such as the TLPO Cancer Vaccine, stimulates the patient's immune system to recognize and attack cancer cells. This approach can provide a more personalized treatment, potentially leading to longer-lasting responses and fewer side effects compared to traditional therapies. For cancer patients, understanding these mechanisms is crucial as it helps in making informed decisions about their treatment options, balancing efficacy with quality of life.

Toward precision medicine in inflammatory breast cancer.Personalized cell-mediated immunotherapy and vaccination: combating detrimental uprisings of malignancies.