TriAdeno Vaccine and N-803 for Early Prostate Cancer
This study is looking into a new approach for men with early-stage prostate cancer who are currently on active surveillance (close monitoring without immediate treatment). Researchers want to see if combining the TriAdeno vaccine with a drug called N-803 can help stop prostate tumors from growing. The TriAdeno vaccine targets three specific proteins found in cancer cells, and N-803 is a drug that helps boost your body's immune response. The main goal is to understand how this combination affects the immune cells within the tumor. To join, you must be a man aged 18 or older with a confirmed diagnosis of low- or intermediate-risk prostate cancer that is confined to the prostate and you must be on active surveillance. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 52 participants. The study is designed to test the effects of the TriAdeno vaccine and N-803.
- What's involved
- You would receive the TriAdeno vaccine and N-803 on Day 1 of every 21-day cycle for up to 4 cycles. You will have physical exams, blood tests, and a heart function test.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure effects on the tumor environment at baseline, around cycle 2 or 4, and optionally at 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07574541
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
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~52 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:TriAdeno vaccineN-803
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the effect of TriAdeno vaccine with N-803 on immune infiltration of the local tumor environment
Measured over Baseline/prior to treatment, C2D14 (or as late as C4D21), and optionally at 1 year
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Peter A Pinto, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 mandatory for study initiation.
Serum PSA level of \<20 ng/mL (or \<10ng/mL for participants being treated with 5- alpha-reductase inhibitors)
Clinical stage \<=T2a by digital rectal exam (DRE)
Age \>=18 years
Eastern Cooperative Oncology Group (ECOG) performance status \<=1.
Adequate organ and marrow function as defined below:
Absolute neutrophil count (ANC) \>=1.0 x 109/L
Hemoglobin (Hgb) \>=9 g/dL
Platelets \>=75,000/mcL
Prothrombin International Normalized Ratio (INR) \<1.5 x upper limit of normal (ULN)
Partial thromboplastin time (PTT) \<1.5 x ULN
Total bilirubin \<1.5 x ULN
Aspartate aminotransferase (AST) \<=2.5 x ULN
Alanine aminotransferase (ALT) \<=2.5 x ULN
Creatinine \<=1.5 x ULN
Calculated Creatinine clearance \>=40 mL/min/1.73 m2 for individuals with creatinine levels above institutional normal (using either Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation)
Treatment with steroid therapy must have a washout of at least 6 weeks prior to initiation of study treatment. Physiologic (replacement) doses of steroids as well as nasal, topical, or inhaled steroids are allowed.
Vaccination with a live (attenuated) vaccine (e.g., FluMist(R)) or a killed (inactivated)/subunit vaccine (e.g., PNEUMOVAX(R), Fluzone(R)) must occur not sooner than 28 days or 14 days, respectively, prior to initiation of study treatment.
Participants must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to one (1) month after the last vaccine injection. We also will recommend participants with female partners of childbearing potential to ask them to be on highly effective birth control (hormonal, intrauterine device \[IUD\], surgical sterilization). Participants must not freeze or donate sperm within the same period.
Participants must be able to understand and willing to sign a written informed consent document.
Exclusion
Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy.
Evidence of PCa with metastatic disease.
Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines.
Prior solid organ or bone marrow transplant.
Immunodeficiency or splenectomy.
Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV), confirmed by PCR, and hepatitis B virus (HBV) and hepatitis C virus (HCV), as determined by hepatitis B surface antigen (HBsAg) and HCV serology.
History of autoimmune disease (active or past), except for autoimmune-related thyroid disease, type I diabetes, and vitiligo if the condition(s) is well controlled.
History of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly
Acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions.
Second malignancy within 3 years prior to initiation of study therapy. Note: Individuals with curatively treated non-melanoma skin cancers or non-muscle invasive bladder cancer will not be excluded.
History of herbal products that may decrease PSA levels (e.g., saw palmetto).
Participants who have undergone surgery within 4 weeks prior to initiation of study therapy.
Participants receiving any other investigational agents within 30 days prior to initiation of study therapy.
History of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs.
Uncontrolled intercurrent illness that would limit compliance with study requirements suggested by medical history, physical examination, or standard clinical assessments such as imaging, EKG, and laboratory studies.
What this trial measures
- To determine the effect of TriAdeno vaccine with N-803 on immune infiltration of the local tumor environmentBaseline/prior to treatment, C2D14 (or as late as C4D21), and optionally at 1 year
Change in the density of T-cell immune infiltrates in the malignant portions of prostate using a paired two sample t-test