Immunotherapy Before and After Surgery

NCT06765902 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: ResQ110A-PROS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

High-risk Prostate Cancer

Keywords

Prostate Cancer; High-risk prostate cancer; Immunotherapy; N-803; ETBX-071; M-CENK; Radical prostatectomy; Pre-surgery immunotherapy; Post-surgery immunotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Assessed within 6 months post-surgery.

• Safety (AEs and SAEs)

  Up to 260 weeks.

Other Outcomes (5)

• Quality of life (QoL):

  Approximately 13 months

• Sexual function

  Approximately 13 months

• Changes in immune subsets and antigen-specific immune responses

  Approximately 13 months

Study Arms (1)

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.

Drug: N-803; Drug: ETBX-071; Drug: M-CENK

Interventions

N-803 DRUG

A subcutaneous injection of an IL-15 superagonist.

Standard of Care + Immunotherapy in addition to surgery.

ETBX-071 DRUG

A subcutaneous injection of a prostate-specific antigen (PSA) adenovirus vaccine.

Standard of Care + Immunotherapy in addition to surgery.

M-CENK DRUG

An intravenous infusion of the patient's own NK cells that have been expanded and activated in a laboratory.

Standard of Care + Immunotherapy in addition to surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 treatment.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ALT-803

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bruce Brown

  ImmunityBio, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 9, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): June 30, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-04