RNA-Nanoparticle Vaccine for Melanoma Recurrence

Overseen By Teresa Ware, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Florida

Must be taking: aPD1 therapy

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Active second malignancy, Brain metastases, Uncontrolled infection, Autoimmune disease, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

Duration: 2 months

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new RNA-nanoparticle vaccine for individuals with advanced melanoma or certain types of soft tissue sarcoma. The aim is to determine if the vaccine is safe and feasible for those whose cancer has progressed despite previous treatments. It may suit individuals with melanoma that has worsened after immunotherapy or those with advanced soft tissue sarcoma that cannot be surgically removed. Participants must have a tumor suitable for vaccine production. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must not be on corticosteroids or other immunosuppressive medications within 14 days of starting the trial treatment.

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

Research has shown that mRNA cancer vaccines, including personalized vaccines made from a patient's own tumor cells, are advancing cancer treatment. Early results suggest these vaccines are generally safe for patients. Some participants have reported mild side effects, such as soreness at the injection site or mild flu-like symptoms.

This vaccine remains in the early testing stages, so researchers are primarily assessing its safety and tolerability. Early trials focus heavily on monitoring side effects to ensure they are manageable. Although this vaccine is new, mRNA has been used in other vaccines and has demonstrated promising safety results. Prospective trial participants should know that their safety is a top priority, and they will be closely monitored for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for melanoma recurrence, like surgery, radiation, and immunotherapy, aim to target cancer cells directly or boost the immune system's response to cancer. But the RNA-nanoparticle vaccine offers a fresh approach. This vaccine uses tiny lipid particles loaded with mRNA from the patient's own tumor, teaching the immune system to specifically recognize and attack melanoma cells, potentially minimizing damage to healthy cells. Researchers are excited because this method taps into the body's natural defenses in a more personalized way, which could lead to more effective and targeted treatment outcomes.

What evidence suggests that this RNA-Nanoparticle vaccine might be an effective treatment for melanoma?

Research has shown that mRNA-based cancer vaccines, such as the personalized total tumor mRNA loaded DOTAP liposome vaccine in this trial, hold promise for treating cancer. These vaccines enhance the body's immune response specifically against cancer cells. In studies with mice, mRNA vaccines triggered strong immune responses, effectively fighting tumors. Although human data is still developing, the mechanism of these vaccines suggests they could help the immune system target and destroy melanoma cells. This approach represents a modern and exciting area of cancer treatment research. ^{1 4 5 6 7}

Who Is on the Research Team?

Leighton Elliott, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage IIB-IV melanoma that worsened on anti-PD1 therapy. They must be in good physical condition, not have multiple cancers, and agree to use birth control. The disease must allow for vaccine creation from a surgical sample, and they can't have had certain treatments or conditions that would risk their safety.

Inclusion Criteria

I do not have more than one active cancer.

I am fully active and can carry on all my pre-disease activities without restriction.

I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

I have unstable chest pain.

I am willing and able to use birth control during and for 4 months after the study.

I am currently pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RNA-LP vaccine, with a focus on determining the maximum tolerated dose and overall response rate

2 months

3 visits (in-person) for vaccination series

Follow-up

Participants are monitored for progression-free survival and overall response rate after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Autologous total tumor mRNA loaded DOTAP liposome vaccine

Trial Overview

The study tests a new RNA-nanoparticle (RNA-NP) vaccine made from the patient's own tumor material against early melanoma recurrence after previous anti-PD-1 antibody treatment. It aims to see if this personalized vaccine is safe and feasible as a treatment option.

How Is the Trial Designed?

Group I: mRNA-nanoparticle (mRNA-NP) vaccine Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Florida Department of Health

Collaborator

Trials

30

Recruited

13,000+

Citations

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NCT05264974 | Novel RNA-nanoparticle Vaccine for the ...

The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8540049/

mRNA-Based Cancer Vaccines: A Therapeutic Strategy for the ...

The use of cancer vaccines to enhance cell-mediated immunity is considered to be one of the most modern immunotherapy options for cancer treatment.

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synapse.patsnap.com

synapse.patsnap.com/drug/16b09d05c2f94e9d802212a39a1c621d

Autologous total tumor mRNA loaded DOTAP liposome ...

Novel RNA-nanoparticle Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy. 100 Clinical Results associated ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2405844024030020

The clinical impact of mRNA therapeutics in the treatment ...

This review aims to elucidate the advancements in the clinical applications of mRNAs for addressing significant health-related challenges such as cancer, ...

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nature.com/articles/s41392-024-02002-z

Progress and prospects of mRNA-based drugs in pre- ...

Their findings revealed that the mRNA vaccine markedly elicited robust T-cell-mediated immune responses in tumor-bearing mice, leading to a ...

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pmc.ncbi.nlm.nih.gov

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mRNA cancer vaccines from bench to bedside - PubMed Central

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cancer.gov

cancer.gov/publications/dictionaries/cancer-drug/def/autologous-total-tumor-mrna-loaded-liposome-vaccine

autologous total tumor mRNA loaded liposome vaccine

An mRNA-based, personalized cancer vaccine consisting of total tumor RNA (TTRNA) derived from autologous tumor cells, formulated in DOTAP lipid nanoparticles.