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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). 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
Primary Outcome
Clinical response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient
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 |
Why NCT03480152 stopped before completion
NCT03480152 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03480152's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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