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
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
2 other identifiers
interventional
52
1 country
1
Brief 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....
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2026
CompletedFirst Posted
Study publicly available on registry
May 8, 2026
CompletedStudy Start
First participant enrolled
May 13, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2027
Study Completion
Last participant's last visit for all outcomes
June 15, 2028
May 8, 2026
May 5, 2026
1.1 years
May 7, 2026
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the effect of TriAdeno vaccine with N-803 on immune infiltration of the local tumor environment
Change in the density of T-cell immune infiltrates in the malignant portions of prostate using a paired two sample t-test
Baseline/prior to treatment, C2D14 (or as late as C4D21), and optionally at 1 year
Secondary Outcomes (2)
To assess the adverse events associated with TriAdeno vaccine and N-803
Day 1 of each cycle, and through at least 30 days after last treatment
To determine the effect of the TriAdeno vaccines with N-803 on the change in PSA
Day 1 of each cycle after C1, 30 days after last treatment, and in follow-up about every 3 months for 1 year and every 6 months for the subsequent 4 years after the end of study therapy
Study Arms (1)
Arm 1
EXPERIMENTALTriAdeno vaccine with N-803
Interventions
The TriAdeno vaccine will be administered on Day 1 of every 21-day cycle for up to 4 cycles.
Eligibility Criteria
You may qualify if:
- 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
- +7 more criteria
You may not qualify if:
- 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
- controlled angina, or history (\<1 year prior to initiation of study therapy) of ventricular arrhythmia.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter A Pinto, M.D.
National Cancer Institute (NCI)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2026
First Posted
May 8, 2026
Study Start (Estimated)
May 13, 2026
Primary Completion (Estimated)
June 15, 2027
Study Completion (Estimated)
June 15, 2028
Last Updated
May 8, 2026
Record last verified: 2026-05-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available as soon as possible or at the time of associated publication. Data not published in a manuscript will be shared via public source once the data set completes QC.
- Access Criteria
- Clinical data will be made available upon request and with the permission of the study Pl. Genomic data are made available via dbGAP through requests to the data custodians.
This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing.