Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Multi-Targeted Recombinant Ad5 (CEA/MUC1/Brachyury) Based Immunotherapy Vaccine Regimen in People With Advanced Cancer
NCT03384316 · View on ClinicalTrials.gov ↗
Study Summary
Background: ETBX-011, ETBX-061, and ETBX-051 are cancer vaccines. Their goal is to teach the immune system to target and kill cancer cells. The vaccines target 3 proteins found in many types of cancer. Researchers think targeting all 3 proteins in unison will have the best results. Objective: To test the safety of combining ETBX-011, ETBX-061, and ETBX-051 and their effects on the immune system. Eligibility: People ages 18 and older with advanced cancer that has not responded to standard therapies Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Scan: They will lie in a machine that takes pictures of the body. Participants will receive the 3 vaccines through 3 shots under the skin every 3 weeks for 3 doses, then every 8 weeks for up to 1 year. They will have blood and urine tests at each vaccine visit. They will have scans and other measurements of their tumor after 9 weeks and then at their vaccine visits every 8 weeks. Participants will keep a diary of symptoms at the injection site. Participants will have a visit 90 days after their final treatment. This will include a physical exam and blood and urine tests. If they have any ongoing side effects, they will be followed until these end or are not changing. After this visit, they will be called every 3 months for the first year, every 6 months for the next 2 years, then every 12 months for another 2 years to see how they are doing. Participants will have the option to enroll in a long-term follow-up study. ...
Conditions Studied
Interventions
- BIOLOGICAL ETBX-051; adenoviral brachyury vaccine
- BIOLOGICAL ETBX-061; adenoviral Mucin-1 (MUC1) vaccine
- BIOLOGICAL ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2020-08-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03384316
The ClinicalTrials.gov registry entry for NCT03384316 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 11 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 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which ETBX-051; adenoviral brachyury vaccine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03384316 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03384316 about?
NCT03384316 is a clinical study titled "Multi-Targeted Recombinant Ad5 (CEA/MUC1/Brachyury) Based Immunotherapy Vaccine Regimen in People With Advanced Cancer". Background: ETBX-011, ETBX-061, and ETBX-051 are cancer vaccines. Their goal is to teach the immune system to target and kill cancer cells. The vaccines target 3 proteins found in many types of cancer. Researchers think targeting all 3 proteins in unison will have the best results. Objective: To ...
What is the current status of trial NCT03384316?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2018-01-31. Estimated completion is 2020-08-24.
What conditions does trial NCT03384316 study?
This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Lung Cancer, Neoplasms, Colon Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03384316?
The interventions under investigation include: ETBX-051; adenoviral brachyury vaccine (BIOLOGICAL), ETBX-061; adenoviral Mucin-1 (MUC1) vaccine (BIOLOGICAL), ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03384316?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03384316 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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