Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07574541
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Adenocarcinoma
  • Carcinoma
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms, Glandular and Epithelial
  • Prostate Cancer

Eligibility Criteria

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

Interventions

  • TriAdeno vaccine — BIOLOGICAL
    The TriAdeno vaccine will be administered on Day 1 of every 21-day cycle for up to 4 cycles.
  • N-803 — DRUG
    N-803 will be administered on Day 1 of every 21-day cycle for up to 4 cycles.

Study Details

Background: Prostate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing. Objective: To test TriAdeno and N-803 in people with early-stage prostate cancer. Eligibility: People aged 18 years and older with early-stage low- or medium-risk prostate cancer. Design: Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam. TriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle. Participants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms. Blood tests, imaging scans, and other tests will be repeated during the study. A tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later. Participants will have follow-up phone calls for 5 years....

Key Dates

Start date
Jun 16, 2026
Status verified
Jun 2026
Primary completion
Jun 15, 2027
Completion
Jun 15, 2028

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    TriAdeno vaccine with N-803

Primary Outcome Measure

To determine the effect of TriAdeno vaccine with N-803 on immune infiltration of the local tumor environment [ Time Frame: Baseline/prior to treatment, C2D14 (or as late as C4D21), and optionally at 1 year ]

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

Related Studies