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NCT07574541 · ClinicalTrials.gov registry record · Phase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Not yet
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT07574541: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT07574541 is a Phase 2 study that has not yet begun recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07574541, a Phase 2 study, has not yet begun recruiting, sponsored by National Cancer Institute (NCI).
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
Background: Prostate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing. Objective: To test TriAdeno and N-803 in people with early-stage prostate cancer. Eligibility: People aged 18 years and older with early-stage low- or medium-risk prostate cancer. Design: Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam. TriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle. Participants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms. Blood tests, imaging scans, and other tests will be repeated during the study. A tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later. Participants will have follow-up phone calls for 5 years....
Primary Outcome
Change in the density of T-cell immune infiltrates in the malignant portions of prostate using a paired two sample t-test
Interventions
- DRUG N-803
- BIOLOGICAL TriAdeno vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2028-06-15 |
| Phase | Phase 2 |
What is known before NCT07574541 opens enrollment
NCT07574541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which N-803 is the first listed.
NCT07574541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07574541 about?
NCT07574541 is a clinical study titled "Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance". Background: Prostate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers ...
What is the current status of trial NCT07574541?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2026-07-15. Estimated completion is 2028-06-15.
What interventions are being tested in trial NCT07574541?
The interventions under investigation include: N-803 (DRUG), TriAdeno vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT07574541?
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 NCT07574541's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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