IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previ… (NCT07686380) | Clinical Trial Compass
Not Yet RecruitingPhase 2
IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy
United States65 participantsStarted 2026-08-18
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Histopathological confirmation of prostate adenocarcinoma by the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center prior to the study treatment initiation. If no pathologic specimen is available, participants may enroll with a pathologist s report showing a histologic diagnosis of prostate adenocarcinoma and a clinical course consistent with the disease from any outside site.
* Biochemically recurrent prostate cancer, defined as PSA over 0.8 ng/ml following radical prostatectomy or \>= 2 ng/ml above the nadir following definitive radiotherapy or definitive radiotherapy (including brachytherapy) for localized prostate cancer.
* Participants must be at least 1 year removed from definitive local therapy before the study treatment initiation.
* Recovery to baseline from acute toxicity related to prior therapy, including surgery and radiation.
* Hepatic function eligibility parameters: Bilirubin (total and direct) \<= upper limit of normal (ULN) (OR in participants with Gilbert s syndrome, a total bilirubin \<= 3.0), aspartate transaminase (AST) and alanine transaminase (ALT) \<= 1.5 times upper limit of normal.
* Adequate renal function defined by a calculated creatinine clearance \> 50 mL/min according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24-hour urine collection.
* ECOG performance score 0-1.
* No other active malignancies within the 36 months prior to the study treatment initiation (w…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial testing N-803, an IL-15 superagonist, with or without an ETBX-071 vaccine — how does being in Phase 2 affect what's known so far about the safety and effectiveness of these treatments for biochemically recurrent prostate cancer?
2Since the trial is specifically for patients who've already had stereotactic body radiation therapy, does my treatment history match what this study is looking for, and would you be able to tell me more once it starts recruiting?
3The trial is comparing N-803 alone versus N-803 combined with the ETBX-071 vaccine — given my current situation, do you think one of those approaches would make more sense for me, or would that be determined by random assignment?
4While this trial isn't yet recruiting, are there other active trials or standard treatments for biochemically recurrent prostate cancer that I should be considering in the meantime so I'm not delaying care?
5What would 'efficacy' actually look like in practice for a trial like this — for example, would we be measuring PSA levels, time before further progression, or something else, and how would that help us judge whether a treatment like this is working for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of N-803 alone or with ETBX-071 vaccine
Timeframe: D1 of each cycle of immunotherapy, at the end of treatment and every 4-8 weeks during follow-up until up to 5 years