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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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07686380
The ClinicalTrials.gov registry entry for NCT07686380 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 65 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 N-803 is the first listed.
NCT07686380 reports 0 study locations.
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.
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