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NCT03480152 · ClinicalTrials.gov registry record · Phase 1
Messenger RNA (mRNA)-Based, Personalized Cancer Vaccine Against Neoantigens Expressed by the Autologous Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT03480152: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03480152 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03480152, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: Exome sequencing can identify certain gene mutations in a person's tumor. This can then be used to create cancer treatments. In this study, researchers will make a treatment called a messenger ribonucleic acid (mRNA) vaccine. The vaccine might cause certain tumors to shrink. Objective: To see if the mRNA vaccine is safe and can cause metastatic melanoma or epithelial tumors to shrink. Eligibility: People 18-70 years old with metastatic melanoma or epithelial cancer Design: Participants will be screened under protocol 99-C-0128. Participants will provide samples under protocol 03-C-0277: Participants will provide a piece of their tumor from a previous surgery or biopsy. Participants will have leukapheresis: Blood is removed through a needle in one arm and circulated through a machine that takes out the white blood cells. The blood is then returned through a needle in the other arm. Participants will have many tests: Scans and x-rays Heart and lung function tests Blood and urine tests Participants will receive the mRNA vaccine every 2 weeks for up to 8 weeks. They will get the vaccine as an injection into the upper arm or thigh. They may receive a second course of vaccines if the study doctor determines it is needed. Participants will have follow-up visits approximately 2 weeks after their final vaccine, then 1 month later, then every 1-2 months for the first year, and then once a year for up to 5 years. Each visit may take up to 2 days and include: Physical exam Blood tests Scans Leukapheresis at the first visit
Interventions
- BIOLOGICAL National Cancer Institute (NCI)-4650, a messenger ribonucleic acid (mRNA)-based, Personalized Cancer Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-05-18 |
| Est. Completion | 2019-11-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03480152
The ClinicalTrials.gov registry entry for NCT03480152 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which National Cancer Institute (NCI)-4650, a messenger ribonucleic acid (mRNA)-based, Personalized Cancer Vaccine is the first listed.
NCT03480152 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03480152 about?
NCT03480152 is a clinical study titled "Messenger RNA (mRNA)-Based, Personalized Cancer Vaccine Against Neoantigens Expressed by the Autologous Cancer". Background: Exome sequencing can identify certain gene mutations in a person's tumor. This can then be used to create cancer treatments. In this study, researchers will make a treatment called a messenger ribonucleic acid (mRNA) vaccine. The vaccine might cause certain tumors to shrink. Objective:...
What is the current status of trial NCT03480152?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2018-05-18. Estimated completion is 2019-11-05.
What interventions are being tested in trial NCT03480152?
The interventions under investigation include: National Cancer Institute (NCI)-4650, a messenger ribonucleic acid (mRNA)-based, Personalized Cancer Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03480152?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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