High-risk Prostate CancerPhase 2NCT06765902
Immunotherapy Before and After Surgery
A Phase 2 study testing N-803, ETBX-071 and M-CENK in people with High-risk Prostate Cancer, run by ImmunityBio, Inc..
Trial summary
This Phase 2 clinical trial is testing a new immunotherapy combination (N-803, ETBX-071, M-CENK) for men with high-risk prostate cancer before and after prostate surgery. The goal is to see if this treatment improves cancer outcomes and is safe. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- High-risk Prostate Cancer
- What is being tested?
- N-803, ETBX-071 and M-CENK
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 30 Jun 2031
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Must be 18 years or older.
- Consent: Able to understand and provide signed informed consent that complies with Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- Diagnosis: Histologically confirmed prostate adenocarcinoma (unless a local pathologist's report shows consistent findings).
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life Expectancy: Must have a life expectancy of at least 10 years.
- Germline Testing: Must have undergone germline testing at the time of initial diagnosis (and at recurrence, if applicable).
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- Metastasis: No evidence of soft tissue disease metastasis (visceral or lymph nodes) on CT/MRI scan.
- Autoimmune Disease: No active or organ-threatening autoimmune disease.
- High-Risk Prostate Cancer: Must have high-risk or very high-risk prostate cancer according to 2024 NCCN guidelines (PSA >20 ng/mL, or Gleason Grade Group ≥4, or ≥cT3a).
- Adequate Hematologic and Organ Function: Must meet specific criteria for absolute neutrophil count (ANC), lymphocyte count, platelet count, hemoglobin, INR or aPTT, AST, ALT, and alkaline phosphatase levels. Certain exceptions are made for participants with liver or bone metastases.
- Ability to Attend Visits: Must be able to attend required study visits and return for adequate follow-up.
- Contraception: If male and not surgically sterile, must agree to use effective contraception for up to 7 months after treatment.
Who cannot join
- Prior Prostate Treatments: Prior surgical, cryotherapy, or high-intensity focused ultrasound treatment for prostate cancer; prior orchiectomy or hormonal therapy (GnRH agonists, NSAA).
- Prior Anti-Androgen Therapy: Prior treatment with first-generation or second-generation androgen receptor (AR) inhibitors (e.g., bicalutamide, flutamide, nilutamide, cyproterone acetate; enzalutamide, apalutamide, or darolutamide).
- Organ Transplantation: Receipt of any organ transplantation (excluding those that don't require immunosuppression, like corneal or hair transplants).
- Corticosteroid Use: Chronic systemic corticosteroid administration (>14 days within 28 days before treatment initiation) except for topical, inhaled, or nasal corticosteroids.
- Active Autoimmune Disease: Active autoimmune disease (e.g., Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome, or active Graves' disease). Exceptions are made for those with a history of autoimmune disease that did not require systemic immunosuppression and does not threaten vital organ function.
- Medications Affecting Urinary Symptoms or PSA: Use of medications for urinary symptoms (5-alpha reductase inhibitors, alternative medications known to alter PSA levels) within 28 days prior to study initiation.
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- Recent Major Surgery or Systemic Therapy: Major surgery or systemic therapy (including investigational therapies) within 28 days prior to study initiation.
- Allergic Reactions: History of allergic reactions to compounds with similar chemical or biological composition to the study drugs.
- Significant Cardiovascular or Cerebrovascular Disease: Clinically significant cardiovascular/cerebrovascular disease (e.g., stroke, myocardial infarction, unstable angina, congestive heart failure, serious cardiac arrhythmia, or uncontrolled hypertension) within six months prior to the first planned dose of study drugs.
- Intercurrent Medical Illness: Serious intercurrent medical illness that would interfere with participation.
- Infections: Active HIV, hepatitis B or C infection.
- Live Attenuated Vaccines: Administration of a live, attenuated vaccine within three weeks before study entry or anticipation that such a vaccine will be required during the study.
- Inability to Comply: The investigator deems the participant unable or unwilling to comply with study requirements.
About this study
Official title: Open-Label, Phase 2 Clinical Trial of Pre-Surgery and Post-Surgery Immunotherapy With N-803, ETBX-071, and M-CENK in Combination With Surgery for Participants With High-Risk Prostate Cancer Pre-Prostatectomy.
This Phase 2 clinical trial is testing a new immunotherapy combination (N-803, ETBX-071, M-CENK) for men with high-risk prostate cancer before and after prostate surgery. The goal is to see if this treatment improves cancer outcomes and is safe.
Read the detailed description
This study is an open-label, Phase 2 clinical trial investigating the efficacy and safety of a three-part immunotherapy regimen in combination with surgery for men with high-risk prostate cancer who have not yet undergone a prostatectomy. The immunotherapy consists of three components:
N-803 (Nogapendekin Alfa Inbakicept): A soluble complex consisting of a modified human interleukin-15 (IL-15) variant bound to a human IL-15 receptor alpha subunit/human immunoglobulin G (IgG) Fc fusion protein. N-803 acts as a growth and activation factor for natural killer (NK) cells and effector and memory T-cells, enhancing their ability to kill cancer cells and stimulate an immune response. It is administered subcutaneously.
ETBX-071 (hAd5 [E1-, E2b-, E3-]-PSA Vaccine): A replication-defective human adenovirus serotype 5 vector modified to encode human prostate-specific antigen (PSA). This vaccine is designed to induce a cell-mediated immune response against PSA-expressing prostate cancer cells. It is administered subcutaneously.
M-CENK (Autologous Memory Cytokine-Enriched NK Cells): These are the patient's own NK cells that are collected through apheresis, expanded and activated ex vivo using cytokines (IL-12, IL-15, and IL-18) to enhance their cytotoxicity and IFN-γ production. The resulting M-CENK cells are then infused intravenously.
Study Design:
The study involves three main phases:
Pre-surgery Immunotherapy: Participants receive N-803, ETBX-071, and M-CENK according to a specific schedule for six weeks before undergoing prostatectomy.
Surgery: Participants undergo a radical prostatectomy.
Post-surgery Immunotherapy: Following surgery, participants receive four cycles of the same immunotherapy regimen (N-803, ETBX-071, and M-CENK) over a 24-week period. Some participants may also receive external beam radiation therapy (EBRT) post-surgery at the discretion of the investigator.
Endpoints:
The study will assess several endpoints, including:
Primary Endpoints: Event-free survival (EFS) and biochemical recurrence-free survival (bRFS) are the main measures of the treatment's effectiveness in preventing cancer recurrence.
Secondary Endpoints: These include the rate of PSA reduction within six months post-surgery and safety assessments (adverse events, serious adverse events, changes in vital signs and laboratory tests).
Exploratory Endpoints: These are additional measures to assess quality of life, sexual function, immune responses, and changes in the tumor microenvironment.
Patient Selection:
The study includes men with high-risk prostate cancer, defined by specific criteria related to PSA levels, Gleason score, and tumor stage. Participants must meet specific inclusion criteria and cannot have certain pre-existing conditions or prior treatments that might interfere with the study.
Follow-up:
Participants will be followed for up to five years after completing the treatment, with regular monitoring and assessments.
This detailed description provides a more comprehensive overview of the study's design, methodology, and objectives.
- Conditions
- High-risk Prostate Cancer
- Being tested
- N-803, ETBX-071, M-CENK
- Keywords
- Prostate Cancer, High-risk prostate cancer, Immunotherapy, N-803, ETBX-071, M-CENK, Radical prostatectomy, Pre-surgery immunotherapy, Post-surgery immunotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-803Drug
A subcutaneous injection of an IL-15 superagonist.
ETBX-071Drug
A subcutaneous injection of a prostate-specific antigen (PSA) adenovirus vaccine.
M-CENKDrug
An intravenous infusion of the patient's own NK cells that have been expanded and activated in a laboratory.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care + Immunotherapy in addition to surgery. | Experimental | The experimental arm of this study is the treatment group receiving the combination of pre- and post-surgery immunotherapy with N-803, ETBX-071, and M-CENK in addition to surgery. Receives: Drug: N-803; Drug: ETBX-071; Drug: M-CENK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
The length of time from surgery to the first occurrence of disease recurrence (biochemical failure, local/regional recurrence, distant metastasis) or death.
Measured: These are assessed from the date of surgery until the occurrence of disease recurrence (EFS) or biochemical recurrence (bRFS), or until the end of the five-year follow-up period.
Biochemical recurrence-free survival (bRFS)
The length of time from surgery to the first evidence of biochemical recurrence (two sequential increases in PSA levels by >0.2 ng/ml within 3-4 weeks) or death.
Measured: These are assessed from the date of surgery until the occurrence of disease recurrence (EFS) or biochemical recurrence (bRFS), or until the end of the five-year follow-up period.
Secondary outcomes (2)
Rate of PSA reduction
The percentage decrease in PSA levels within six months post-surgery.
Measured: Assessed within 6 months post-surgery.
Safety (AEs and SAEs)
Assessment of adverse events (AEs), serious adverse events (SAEs), and clinically important changes in laboratory values and vital signs.
Measured: Up to 260 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start15 Dec 2025 (estimated)
- Primary completion31 Jan 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Why it stopped: Study was redeveloped into a new protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Prostate CancerStudies of the same condition, open and under way.
- 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
- Model description
- The interventional model represents a sophisticated approach that leverages both established surgical techniques and cutting-edge immunotherapies, delivered in a carefully structured sequence, to address a challenging clinical problem. The inclusion of autologous cell therapy adds a level of personalization, while the standardized procedures and detailed assessments ensure robust and reliable data collection.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Brown, Study chair, ImmunityBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765902
- Sponsor's protocol ID
- ResQ110A-PROS
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2024
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Phase 2 Clinical Trial of Pre-Surgery and Post-Surgery Immunotherapy With N-803, ETBX-071, and M-CENK in Combination With Surgery for Participants With High-Risk Prostate Cancer Pre-Prostatectomy.
- ClinicalTrials.gov ID
- NCT06765902
- Acronym / sponsor ID
- ResQ110A-PROS
- Conditions
- High-risk Prostate Cancer
- Keywords
- Prostate Cancer, High-risk prostate cancer, Immunotherapy, N-803, ETBX-071, M-CENK, Radical prostatectomy, Pre-surgery immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was redeveloped into a new protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 9 Jan 2025 (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.
This Phase 2 clinical trial is testing a new immunotherapy combination (N-803, ETBX-071, M-CENK) for men with high-risk prostate cancer before and after prostate surgery. The goal is to see if this treatment improves cancer outcomes and is safe.
Detailed description
This study is an open-label, Phase 2 clinical trial investigating the efficacy and safety of a three-part immunotherapy regimen in combination with surgery for men with high-risk prostate cancer who have not yet undergone a prostatectomy. The immunotherapy consists of three components:
N-803 (Nogapendekin Alfa Inbakicept): A soluble complex consisting of a modified human interleukin-15 (IL-15) variant bound to a human IL-15 receptor alpha subunit/human immunoglobulin G (IgG) Fc fusion protein. N-803 acts as a growth and activation factor for natural killer (NK) cells and effector and memory T-cells, enhancing their ability to kill cancer cells and stimulate an immune response. It is administered subcutaneously.
ETBX-071 (hAd5 [E1-, E2b-, E3-]-PSA Vaccine): A replication-defective human adenovirus serotype 5 vector modified to encode human prostate-specific antigen (PSA). This vaccine is designed to induce a cell-mediated immune response against PSA-expressing prostate cancer cells. It is administered subcutaneously.
M-CENK (Autologous Memory Cytokine-Enriched NK Cells): These are the patient's own NK cells that are collected through apheresis, expanded and activated ex vivo using cytokines (IL-12, IL-15, and IL-18) to enhance their cytotoxicity and IFN-γ production. The resulting M-CENK cells are then infused intravenously.
Study Design:
The study involves three main phases:
Pre-surgery Immunotherapy: Participants receive N-803, ETBX-071, and M-CENK according to a specific schedule for six weeks before undergoing prostatectomy.
Surgery: Participants undergo a radical prostatectomy.
Post-surgery Immunotherapy: Following surgery, participants receive four cycles of the same immunotherapy regimen (N-803, ETBX-071, and M-CENK) over a 24-week period. Some participants may also receive external beam radiation therapy (EBRT) post-surgery at the discretion of the investigator.
Endpoints:
The study will assess several endpoints, including:
Primary Endpoints: Event-free survival (EFS) and biochemical recurrence-free survival (bRFS) are the main measures of the treatment's effectiveness in preventing cancer recurrence.
Secondary Endpoints: These include the rate of PSA reduction within six months post-surgery and safety assessments (adverse events, serious adverse events, changes in vital signs and laboratory tests).
Exploratory Endpoints: These are additional measures to assess quality of life, sexual function, immune responses, and changes in the tumor microenvironment.
Patient Selection:
The study includes men with high-risk prostate cancer, defined by specific criteria related to PSA levels, Gleason score, and tumor stage. Participants must meet specific inclusion criteria and cannot have certain pre-existing conditions or prior treatments that might interfere with the study.
Follow-up:
Participants will be followed for up to five years after completing the treatment, with regular monitoring and assessments.
This detailed description provides a more comprehensive overview of the study's design, methodology, and objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The interventional model represents a sophisticated approach that leverages both established surgical techniques and cutting-edge immunotherapies, delivered in a carefully structured sequence, to address a challenging clinical problem. The inclusion of autologous cell therapy adds a level of personalization, while the standardized procedures and detailed assessments ensure robust and reliable data collection.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care + Immunotherapy in addition to surgery. | Experimental | Drug: N-803, Drug: ETBX-071, Drug: M-CENKThe experimental arm of this study is the treatment group receiving the combination of pre- and post-surgery immunotherapy with N-803, ETBX-071, and M-CENK in addition to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: Must be 18 years or older.
- Consent: Able to understand and provide signed informed consent that complies with Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- Diagnosis: Histologically confirmed prostate adenocarcinoma (unless a local pathologist's report shows consistent findings).
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life Expectancy: Must have a life expectancy of at least 10 years.
Key exclusion criteria (13 listed)
- Prior Prostate Treatments: Prior surgical, cryotherapy, or high-intensity focused ultrasound treatment for prostate cancer; prior orchiectomy or hormonal therapy (GnRH agonists, NSAA).
- Prior Anti-Androgen Therapy: Prior treatment with first-generation or second-generation androgen receptor (AR) inhibitors (e.g., bicalutamide, flutamide, nilutamide, cyproterone acetate; enzalutamide, apalutamide, or darolutamide).
- Organ Transplantation: Receipt of any organ transplantation (excluding those that don't require immunosuppression, like corneal or hair transplants).
- Corticosteroid Use: Chronic systemic corticosteroid administration (>14 days within 28 days before treatment initiation) except for topical, inhaled, or nasal corticosteroids.
- Active Autoimmune Disease: Active autoimmune disease (e.g., Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome, or active Graves' disease). Exceptions are made for those with a history of autoimmune disease that did not require systemic immunosuppression and does not threaten vital organ function.
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 |
|---|---|---|
| N-803A subcutaneous injection of an IL-15 superagonist. | Drug | Standard of Care + Immunotherapy in addition to surgery. |
| ETBX-071A subcutaneous injection of a prostate-specific antigen (PSA) adenovirus vaccine. | Drug | Standard of Care + Immunotherapy in addition to surgery. |
| M-CENKAn intravenous infusion of the patient's own NK cells that have been expanded and activated in a laboratory. | Drug | Standard of Care + Immunotherapy in addition to surgery. |
Primary outcome
Event-free survival (EFS)
Time frame: These are assessed from the date of surgery until the occurrence of disease recurrence (EFS) or biochemical recurrence (bRFS), or until the end of the five-year follow-up period.
The length of time from surgery to the first occurrence of disease recurrence (biochemical failure, local/regional recurrence, distant metastasis) or death.
Biochemical recurrence-free survival (bRFS)
Time frame: These are assessed from the date of surgery until the occurrence of disease recurrence (EFS) or biochemical recurrence (bRFS), or until the end of the five-year follow-up period.
The length of time from surgery to the first evidence of biochemical recurrence (two sequential increases in PSA levels by >0.2 ng/ml within 3-4 weeks) or death.
2 secondary outcomes
Rate of PSA reduction
Time frame: Assessed within 6 months post-surgery.
Safety (AEs and SAEs)
Time frame: Up to 260 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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. This study is not recruiting at the moment.
Bruce Brown study chair
ImmunityBio, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-803, ETBX-071 and M-CENK in people with High-risk Prostate Cancer, run by ImmunityBio, Inc..
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 12 inclusion and 13 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: withdrawn, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: These are assessed from the date of surgery until the occurrence of disease recurrence (EFS) or biochemical recurrence (bRFS), or until the end of the five-year follow-up period.). The study lists 2 primary outcomes in all. 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 5 May 2026.