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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). 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.
Primary Outcome
A dose-limiting toxicity is defined as occurring within 28 days after the first vaccine administration and meeting on of these criteria: Any Grade 3 or greater toxicity or any Grade 2 or higher autoimmune reaction as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0; or generalized erythroderma or macular or papular rash.
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 |
What the finished NCT03481816 record still lists
NCT03481816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which ETBX-051; adenoviral brachyury vaccine is the first listed.
NCT03481816 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03481816's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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