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
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....
Description
Background: * Prostate cancer (PCa) is the most common non-cutaneous cancer and second most common cause of cancer-related death among men living in the United States. * With increasing detection of localized, low-grade PCa in the prostate-specific antigen (PSA) screening era, active surveillance of PCa has emerged as a viable management strategy in selected, favorable risk population. Though active surveillance is the preferred management strategy for low-grade PCa and an option for selected favorable, intermediate risk disease according to the National Comprehensive Cancer Network (NCCN), u…
Eligibility
- Age range
- 18–120 years
- Sex
- Male
- Healthy volunteers
- No
* INCLUSION CRITERIA: * Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostate biopsy core. Biopsies performed at outside institutions should have Gleason score confirmed at the NCI by a genitourinary (GU) pathologist. * Participants must be on active surveillance. * Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \[FFPE\] biopsy core or one H and E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is ma…
Interventions
- BiologicalTriAdeno vaccine
The TriAdeno vaccine will be administered on Day 1 of every 21-day cycle for up to 4 cycles.
- DrugN-803
N-803 will be administered on Day 1 of every 21-day cycle for up to 4 cycles.
Location
- National Institutes of Health Clinical CenterBethesda, Maryland