IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07686380
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • N-803 — DRUG
    15 mg/kg subcutaneous on Day 1 of every 3-week cycle for up to 8 cycles
  • ETBX-71 Vaccine — DRUG
    The dose to be injected is 5(SqrRoot) 10\^11 viral particles (VP) per 1 mL. Injected subcutaneously on Day 1 of every 3-week cycle for a total of up to 8 cycles
  • 18F-DCFPyL — RADIATION
    Single IV dose of 18F-DCFPyL by bolus injection. The target administered activity will be 6.5 mCi with a lower limit of 6 mCi

Study Details

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.

Key Dates

Start date
Jul 12, 2026
Status verified
Jul 2026
Primary completion
Jan 30, 2029
Completion
Jan 30, 2029

Study Design

Enrollment
65 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: N803
    N803
  • Experimental: N803+ETBX-071 vaccine
    N803+ETBX-071 vaccine

Primary Outcome Measure

Efficacy of N-803 alone or with ETBX-071 vaccine [ Time Frame: D1 of each cycle of immunotherapy, at the end of treatment and every 4-8 weeks during follow-up until up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
National Cancer Institute Referral Office
[email protected]
888-624-1937

Find similar trials in Bethesda, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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