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

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 w

Trial Details

NCT ID
NCT07574541
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • TriAdeno vaccine
  • N-803
Locations (sample)
  • Bethesda, Maryland, United States|38.98067,-77.10026

Key Eligibility Criteria

  • Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostat…
  • Participants must be on active surveillance.
  • Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \[FFPE\] biopsy core or one H\&E-stained slide and at least …
  • Serum PSA level of \<20 ng/mL (or \<10ng/mL for participants being treated with 5- alpha-reductase inhibitors)

For full eligibility, visit ClinicalTrials.gov.

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