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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
Sponsor: National Cancer Institute (NCI)
Summary
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....
Official title: Phase II Trial of a 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
Key Details
Gender
MALE
Age Range
18 Years - 120 Years
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2026-05-18
Completion Date
2028-06-15
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
TriAdeno vaccine
The TriAdeno vaccine will be administered on Day 1 of every 21-day cycle for up to 4 cycles.
N-803
N-803 will be administered on Day 1 of every 21-day cycle for up to 4 cycles.
Locations (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, United States