AdenocarcinomaPhase 2NCT07574541
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
A Phase 2 study testing TriAdeno vaccine and N-803 in people with Adenocarcinoma and Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Adenocarcinoma, Prostate Cancer, Neoplasms
- What is being tested?
- TriAdeno vaccine and N-803
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2026to 15 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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\&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
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- Eastern Cooperative Oncology Group (ECOG) performance status <=1.
- Adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) >=1.0 x 10^9/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
- OR
- --Calculated Creatinine clearance >=40 mL/min/1.73 m^2 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 study drug injection. 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937, ncimo_referrals@mail.nih.gov
About this study
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
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.
Read more
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....
Read the detailed 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), up to 35% of men will need radical therapy within 5 years due to progression of PCa.
- Vaccine strategies represent a novel therapeutic approach in the prevention and possible treatment of early-stage PCa. A new trivalent vaccine which targets 3 tumor-associated antigens (PSA, brachyury, and MUC-1) has been shown to induce an immune response in a Phase I study of patients with metastatic castrate-resistant PCa.
- N-803 is an IL-15 agonist that activates and expands T cells and NK cells. N-803 enhances anti-tumor activity in combination with tumor-targeted vaccines. Clinically, multiple studies have demonstrated the safety of tumor-targeted vaccine in combination with PD-1/PD-L1 blockade. Adding N-803 to PD-1/PD-L1 blockade can produce antitumor responses in disease states where responses to PD-1/PD-L1 alone would not be expected.
- The TriAdeno vaccine has not been evaluated in populations with early stage, low grade PCa.
Primary Objective:
-To determine the effect of an Ad5 PSA/MUC-1/brachyury-based immunotherapy vaccine (TriAdeno) with IL-15 superagonist N-803 on immune infiltration of the local tumor environment by comparing pre- and post-treatment CD8+ and CD4+ T-cell density within the malignant portion of prostate biopsies in participants on active surveillance for low and intermediate risk prostate cancer
Eligibility:
- Biopsy-proven, organ confined low or intermediate risk adenocarcinoma of the prostate
- Age >=18 years
- Serum PSA <20 ng/mL (or <10 ng/mL for participants being treated with 5-alpha-reductase inhibitors)
- Eastern Cooperative Oncology Group (ECOG) performance status <=1
Design:
- This is an open-label, non-randomized Phase II trial of TriAdeno vaccine given concurrently with N-803 in participants with localized, early stage, low and intermediate risk PCa on active surveillance.
- The TriAdeno vaccines will be administered subcutaneously (SC) at doses of 5x1011 viral particles (VP) on Day 1 of every 21-day cycle for up to four (4) cycles.
- N-803 will be administered SC at 15 mcg/kg on Day 1 of every 21-day cycle for up to four (4) cycles.
- Up to 49 participants may be treated.
- Conditions
- Adenocarcinoma, Prostate Cancer, Neoplasms, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type
- Being tested
- TriAdeno vaccine, N-803
- Keywords
- Immune Infiltration
- Medical subject headings
- Adenocarcinoma, Prostatic Neoplasms, Neoplasms, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriAdeno vaccineBiological
The TriAdeno vaccine will be administered on Day 1 of every 21-day cycle for up to 4 cycles.
N-803Drug
N-803 will be administered on Day 1 of every 21-day cycle for up to 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | TriAdeno vaccine with N-803 Receives: Biological: TriAdeno vaccine; Drug: N-803 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Toxicities will be reported in a descriptive fashion per type, frequency, and grade
Measured: 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
Change in PSA will be analyzed using a paired two sample t-test.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start29 Oct 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter A Pinto, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574541
- Sponsor's protocol ID
- 10001734
- Other IDs
- 001734-C
- Status last verified
- 16 Oct 2026
- First submitted
- 7 May 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07574541
- Acronym / sponsor ID
- 10001734
- Conditions
- Adenocarcinoma, Prostate Cancer, Neoplasms, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type
- Keywords
- Immune Infiltration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed 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), up to 35% of men will need radical therapy within 5 years due to progression of PCa.
- Vaccine strategies represent a novel therapeutic approach in the prevention and possible treatment of early-stage PCa. A new trivalent vaccine which targets 3 tumor-associated antigens (PSA, brachyury, and MUC-1) has been shown to induce an immune response in a Phase I study of patients with metastatic castrate-resistant PCa.
- N-803 is an IL-15 agonist that activates and expands T cells and NK cells. N-803 enhances anti-tumor activity in combination with tumor-targeted vaccines. Clinically, multiple studies have demonstrated the safety of tumor-targeted vaccine in combination with PD-1/PD-L1 blockade. Adding N-803 to PD-1/PD-L1 blockade can produce antitumor responses in disease states where responses to PD-1/PD-L1 alone would not be expected.
- The TriAdeno vaccine has not been evaluated in populations with early stage, low grade PCa.
Primary Objective:
-To determine the effect of an Ad5 PSA/MUC-1/brachyury-based immunotherapy vaccine (TriAdeno) with IL-15 superagonist N-803 on immune infiltration of the local tumor environment by comparing pre- and post-treatment CD8+ and CD4+ T-cell density within the malignant portion of prostate biopsies in participants on active surveillance for low and intermediate risk prostate cancer
Eligibility:
- Biopsy-proven, organ confined low or intermediate risk adenocarcinoma of the prostate
- Age >=18 years
- Serum PSA <20 ng/mL (or <10 ng/mL for participants being treated with 5-alpha-reductase inhibitors)
- Eastern Cooperative Oncology Group (ECOG) performance status <=1
Design:
- This is an open-label, non-randomized Phase II trial of TriAdeno vaccine given concurrently with N-803 in participants with localized, early stage, low and intermediate risk PCa on active surveillance.
- The TriAdeno vaccines will be administered subcutaneously (SC) at doses of 5x1011 viral particles (VP) on Day 1 of every 21-day cycle for up to four (4) cycles.
- N-803 will be administered SC at 15 mcg/kg on Day 1 of every 21-day cycle for up to four (4) cycles.
- Up to 49 participants may be treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: TriAdeno vaccine, Drug: N-803TriAdeno vaccine with N-803 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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\&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)
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriAdeno vaccineThe TriAdeno vaccine will be administered on Day 1 of every 21-day cycle for up to 4 cycles. | Biological | Arm 1 |
| N-803N-803 will be administered on Day 1 of every 21-day cycle for up to 4 cycles. | Drug | Arm 1 |
Primary outcome
To determine the effect of TriAdeno vaccine with N-803 on immune infiltration of the local tumor environment
Time frame: Baseline/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
2 secondary outcomes
To assess the adverse events associated with TriAdeno vaccine and N-803
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter A Pinto, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TriAdeno vaccine and N-803 in people with Adenocarcinoma and Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Genevieve C Fromm ((240) 858-3663, genevieve.fromm@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effect of TriAdeno vaccine with N-803 on immune infiltration of the local tumor environment (time frame: Baseline/prior to treatment, C2D14 (or as late as C4D21), and optionally at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.