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Cancer Vaccine

RNA-Nanoparticle Vaccine for Melanoma Recurrence

Phase 1

Recruiting

Led By Bently Doonan, MD, MS

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

Subjects must not have more than one active malignancy at the time of enrollment

ECOG performance ≤ 1

Must not have

Subjects with unstable angina pectoris

Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 months after the last dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Summary

This trial will assess if a vaccine can safely stop melanoma progression in those who have not responded to anti-PD1 therapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed but may include typical reactions to vaccines such as soreness at the injection site, fever, fatigue, or allergic reactions due to components of the vaccine or its method of delivery.

Eligibility Criteria

Inclusion Criteria

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

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I do not have more than one active cancer.

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

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

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My cancer does not have the BRAF mutation.

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I received PD1 or PD1/CTLA-4 inhibitors for melanoma after surgery.

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My liver and kidney functions are within the required ranges.

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My condition can be sampled through surgery for vaccine development.

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My melanoma worsened during or soon after adjuvant immunotherapy.

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I am 18 years old or older.

Exclusion Criteria

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

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I have unstable chest pain.

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

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I am currently pregnant or breastfeeding.

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I have had my spleen removed.

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I haven't needed IV drugs for an infection within a week before my vaccine creation or administration.

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I have active hepatitis B or untreated hepatitis C.

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I have an active autoimmune disease that affects my daily life.

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I have severe symptoms from heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility of treatment with RNA-NP vaccine

Maximum tolerated dose

Secondary study objectives

Overall response rate

Progression-free survival

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041

COVID-19 Infection

Upper Respiratory Infection

Cardiovascular Accident (CVA), Unspecified Mechanism

Left partial cranial nerve III palsy

Acute Hyperkalemia

Shortness of Breath

Acute pulmonary embolism and acute deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine

Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine

Trial Design

1Treatment groups

Experimental Treatment

Group I: mRNA-nanoparticle (mRNA-NP) vaccineExperimental Treatment1 Intervention

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,380 Previous Clinical Trials

762,377 Total Patients Enrolled

4 Trials studying Melanoma

126 Patients Enrolled for Melanoma

Bently Doonan, MD, MSPrincipal InvestigatorUniversity of Florida

1 Previous Clinical Trials

29 Total Patients Enrolled

1 Trials studying Melanoma

29 Patients Enrolled for Melanoma

~12 spots leftby Sep 2026

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