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NCT03481816 · ClinicalTrials.gov registry record · Phase 1
Treatment of Castration Resistant Prostate Cancer Using Multi-Targeted Recombinant Ad5 PSA/MUC1/Brachyury Based Immunotherapy Vaccines
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT03481816: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03481816 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03481816, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Background: Metastatic castration resistant prostate cancer (mCRPC) keeps growing even when the amount of testosterone in the body is reduced to very low levels. mCRPC is incurable. Researchers want to develop vaccines to teach the immune system to target and kill cancer cells. They want to test three of these vaccines (ETBX-071, ETBX-061, and ETBX-051) against mCRPC. Objective: To test the safety of combination ETBX-071, ETBX-061, and ETBX-051 and to study their effects on the immune system. Eligibility: People ages 18 and older with mCRPC that has not responded to standard therapies Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Computed tomography (CT) or magnetic resonance imaging (MRI) scans Bone scan Participants will get the vaccines as shots under the skin every 3 weeks for 3 doses. They may then have the shots every 8 weeks for up to 1 year. Participants will keep a diary to record any symptoms from the vaccines. Participants will have blood tests each time they get the vaccines. They will also have scans and other tests to measure the effect the vaccines have on their tumors. Participants will have a visit within 28 days after their last treatment. This includes a physical exam and blood and urine tests. Participants will then be contacted by phone every 3 months for the first year, every 6 months for the next 2 years, and every 12 months for another 2 years. Participants will be asked to join a long-term follow up study.
Interventions
- BIOLOGICAL ETBX-051; adenoviral brachyury vaccine
- BIOLOGICAL ETBX-071; adenoviral PSA vaccine
- BIOLOGICAL ETBX-061; adenoviral MUC1 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-07-24 |
| Est. Completion | 2021-03-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03481816
The ClinicalTrials.gov registry entry for NCT03481816 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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 3 interventions - of which ETBX-051; adenoviral brachyury vaccine is the first listed.
NCT03481816 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03481816 about?
NCT03481816 is a clinical study titled "Treatment of Castration Resistant Prostate Cancer Using Multi-Targeted Recombinant Ad5 PSA/MUC1/Brachyury Based Immunotherapy Vaccines". Background: Metastatic castration resistant prostate cancer (mCRPC) keeps growing even when the amount of testosterone in the body is reduced to very low levels. mCRPC is incurable. Researchers want to develop vaccines to teach the immune system to target and kill cancer cells. They want to test th...
What is the current status of trial NCT03481816?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2018-07-24. Estimated completion is 2021-03-09.
What interventions are being tested in trial NCT03481816?
The interventions under investigation include: ETBX-051; adenoviral brachyury vaccine (BIOLOGICAL), ETBX-071; adenoviral PSA vaccine (BIOLOGICAL), ETBX-061; adenoviral MUC1 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03481816?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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