WithdrawnPhase 2

Immunotherapy Before and After Surgery

Stopped: Study was redeveloped into a new protocol

0Started 2025-12-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). * 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Event-free survival (EFS)

Timeframe: 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)

Timeframe: 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.

Trial details

NCT IDNCT06765902

SponsorImmunityBio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-01-31

View on ClinicalTrials.gov More High-risk Prostate Cancer trials

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Event-free survival (EFS)

Timeframe: 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)

Timeframe: 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.