Study on IL-15 Superagonist With or Without Vaccine for Recurrent Prostate Cancer After Radiation Therapy

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT07686380

Provider View

This clinical trial is exploring whether a drug called N-803, alone or combined with a vaccine, can help reduce PSA levels in men with prostate cancer that has returned after radiation treatment.

Patient Parameters

Program Overview

This study is investigating a new treatment approach for men with prostate cancer that has come back after radiation therapy. The trial is testing a drug called N-803, which may help the immune system fight cancer, either by itself or combined with a vaccine called ETBX-071. The goal is to see if these treatments can lower PSA levels, a marker of prostate cancer activity, in men who have previously received targeted radiation therapy.

Description

Prostate cancer can sometimes return after initial treatment, indicated by rising PSA levels in the blood. This study focuses on men whose prostate cancer has returned after they received a specific type of radiation therapy called stereotactic body radiation therapy (SBRT). The trial is testing a drug called N-803, which boosts the immune system's ability to fight cancer, either alone or with a vaccine called ETBX-071. The vaccine is designed to target PSA, a protein associated with prostate cancer.

Participants will be divided into two groups: one group will receive N-803 alone, and the other will receive both N-803 and the vaccine. The treatments are given as injections under the skin, with each treatment cycle lasting 21 days. Participants will undergo eight cycles of treatment.

The study will monitor the safety and effectiveness of these treatments in reducing PSA levels. Participants will have regular follow-up visits, including blood tests and imaging scans, to track their progress. These visits will continue every 4 to 8 weeks for up to 5 years, with a PET scan every 6 months to check for cancer activity.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer that has returned, indicated by a PSA level over 0.8 ng/ml after surgery or 2 ng/ml above the lowest level after radiation.
  • No signs of cancer spread to soft tissues or bones on scans.
  • PSA levels must have increased by at least 25% after previous SBRT treatment.
  • Good overall health with an ECOG performance score of 0 or 1.
  • No active autoimmune diseases that threaten organ function.
  • At least 18 years old.
  • Must agree to use effective contraception during the study and for four months after the last treatment.
  • Must not have any other active cancers within the last 36 months, except for certain skin cancers or bladder carcinoma in situ.
  • Must have adequate liver and kidney function based on specific blood tests.
  • Must have had prior SBRT treatment and a documented PSA rise of 25% or more from the lowest level after SBRT.
  • Must have a baseline testosterone level of at least 100 ng/dl.
  • Must be able to understand and sign a written informed consent document.

Exclusion Criteria

  • Have a compromised immune system due to conditions like HIV, hepatitis B or C, or other immunodeficiency diseases.
  • Have active autoimmune diseases such as lupus, scleroderma, or myasthenia gravis.
  • Have received any organ transplants that require immunosuppression.
  • Have been on long-term systemic corticosteroids within 28 days before starting the study.
  • Have taken medications that affect PSA levels within 28 days before starting the study.
  • Have had major surgery within 28 days before starting the study.
  • Have received any systemic therapy or radiation therapy within 28 days before starting the study.
  • Have a history of severe allergic reactions to similar drugs.
  • Have significant heart or blood vessel diseases, such as recent stroke or heart attack, or uncontrolled high blood pressure.
  • Have any serious medical conditions that would interfere with the study treatment.

Locations

FACILITYZIPCITYSTATE
National Institutes of Health Clinical Center20892BethesdaMaryland

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