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Cancer Vaccine

RNA-Nanoparticle Vaccine for Melanoma Recurrence

Q: Is there an age limit for the participants of this trial?

Eligibility for this trial is limited to persons over the age of majority and younger than 99 years old.

Q: Are there still vacancies for this experiment?

Clinicaltrials.gov reveals that this trial is not accepting new participants; the study, which was initially posted in February 2024 and last modified on November 2023, has closed enrollment for now. Fortunately, there are 1729 other clinical trials actively recruiting at this time.

Q: Has the FDA accepted mRNA-nanoparticle (mRNA-NP) vaccine for public use?

Due to the early stage of clinical testing, mRNA-nanoparticle (mRNA-NP) <a href="https://www.withpower.com/clinical-trials/vaccine">vaccine</a> has yet to demonstrate its efficacy and safety reliably. Thus, we rate it a 1 on our scale from 1 to 3.

Q: What characteristics make individuals an ideal candidate for this investigation?

This clinical trial is recruiting 18 adults within the ages of 18 and 99 who have recently been diagnosed with <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>. To be accepted, participants must meet certain criteria including: having received either PD1 or combination aPD1/CTLA-4 inhibition as adjuvant treatment for stage IIB-IV melanoma following surgical resection; being BRAF wildtype; an ECOG performance ≤ 1; serum direct bilirubin ≤ 1.5 x ULN (upper limit of normal); AST and ALT≤ 2.5 x ULN (If confirmed liver metastases: AST and ALT≤ 5 x UL

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of treatment with RNA-NP vaccine

Maximum tolerated dose

Secondary outcome measures

Overall response rate

Progression-free survival

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592

27%

Injection site pain

25%

Pyrexia

14%

Decreased appetite

14%

Upper respiratory tract infection

14%

Diarrhea

10%

Injection site erythema

Nasopharyngitis

Irritability postvaccinal

Headache

Vomiting

Injection site induration

Myalgia

Hypersomnia

Injection site swelling

Fatigue

Crying

Injection site hemorrhage

Gastroenteritis

Pneumonia

Animal Bite

100%

80%

60%

40%

20%

Study treatment Arm

ATIV (6 to <72 Months)

TIV (6 to <72 Months)

Comparator TIV (6 to <72 Months)

Trial Design

1Treatment groups

Experimental Treatment

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

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,687 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for the participants of this trial?

"Eligibility for this trial is limited to persons over the age of majority and younger than 99 years old."

Answered by AI

Are there still vacancies for this experiment?

"Clinicaltrials.gov reveals that this trial is not accepting new participants; the study, which was initially posted in February 2024 and last modified on November 2023, has closed enrollment for now. Fortunately, there are 1729 other clinical trials actively recruiting at this time."

Answered by AI

Has the FDA accepted mRNA-nanoparticle (mRNA-NP) vaccine for public use?

"Due to the early stage of clinical testing, mRNA-nanoparticle (mRNA-NP) vaccine has yet to demonstrate its efficacy and safety reliably. Thus, we rate it a 1 on our scale from 1 to 3."

Answered by AI

What characteristics make individuals an ideal candidate for this investigation?

"This clinical trial is recruiting 18 adults within the ages of 18 and 99 who have recently been diagnosed with melanoma. To be accepted, participants must meet certain criteria including: having received either PD1 or combination aPD1/CTLA-4 inhibition as adjuvant treatment for stage IIB-IV melanoma following surgical resection; being BRAF wildtype; an ECOG performance ≤ 1; serum direct bilirubin ≤ 1.5 x ULN (upper limit of normal); AST and ALT≤ 2.5 x ULN (If confirmed liver metastases: AST and ALT≤ 5 x UL"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Novel RNA-nanoparticle Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy

2024. "Novel RNA-nanoparticle Vaccine for the Treatment of Early Melanoma Recurrence Following Adjuvant Anti-PD-1 Antibody Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05264974.

All > Immunotherapy