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NCT07686380 · ClinicalTrials.gov registry record · Phase 2
IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Not yet
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT07686380: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT07686380 is a Phase 2 study that has not yet begun recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07686380, a Phase 2 study, has not yet begun recruiting, sponsored by National Cancer Institute (NCI).
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
Background: Biochemically recurrent prostate cancer (BCR) occurs when prostate-specific antigen (PSA) levels in the blood rise after surgery or radiation. BCR affects 30,000 to 50,000 men each year. Researchers want to know if a drug (N-803) alone or combined with a vaccine (ETBX-071) can reduce PSA in BCR prostate cancer after radiation. Objective: To test a study drug alone and combined with a vaccine in people with BCR prostate cancer who have been treated with targeted radiation to areas of recurrent prostate cancer in the past. Eligibility: People aged 18 years and older with BCR prostate cancer who have previously undergone treatment with stereotactic body radiation therapy (SBRT). Design: Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and kidney function. They will have 3 different imaging scans of their tumors. N-803 is injected under the skin of the abdomen. ETBX-071 is injected under the skin of thigh. Participants will be divided into 2 groups: 1 group will get N-803 alone; 1 group will get both N-803 and ETBX-071. The drug or drugs will be given on the first day of 21-day treatment cycles. Participants will have 8 treatment cycles. Participants will have a follow-up visit 3 weeks after their last dose of the study drugs. Blood tests and all 3 imaging scans will be repeated. Follow-up visits will continue every 4 to 8 weeks for 5 years. These visits will include a positron emission tomography (PET) scan every 6 months.
Primary Outcome
PSA30 response- defined as a \>= 30% reduction in PSA from PSA at C1D1 of immunotherapy (comparing C1D1 PSA to timepoints during and after immunotherapy). The fractions with PSA30 response will be reported along with a 95% confidence interval, separately for the two randomized treatment groups.
Interventions
- DRUG N-803
- DRUG ETBX-71 Vaccine
- RADIATION 18F-DCFPyL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2029-01-30 |
| Phase | Phase 2 |
What is known before NCT07686380 opens enrollment
NCT07686380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 3 interventions - of which N-803 is the first listed.
NCT07686380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07686380 about?
NCT07686380 is a clinical study titled "IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy". Background: Biochemically recurrent prostate cancer (BCR) occurs when prostate-specific antigen (PSA) levels in the blood rise after surgery or radiation. BCR affects 30,000 to 50,000 men each year. Researchers want to know if a drug (N-803) alone or combined with a vaccine (ETBX-071) can reduce PS...
What is the current status of trial NCT07686380?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2026-07-15. Estimated completion is 2029-01-30.
What interventions are being tested in trial NCT07686380?
The interventions under investigation include: N-803 (DRUG), ETBX-71 Vaccine (DRUG), 18F-DCFPyL (RADIATION).
Who is sponsoring clinical trial NCT07686380?
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 NCT07686380's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 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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