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 range18 Years

SexMALE

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 …

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 range18 Years

SexMALE

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.