Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer

NCT06014255 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: J2269IRB00340678
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 5

Brief Summary

This study evaluates the efficacy, anti-tumor effect, and immunogenicity of neoadjuvant enoblituzumab given before radical prostatectomy. Patients will be randomized to enoblituzumab for a total of 12 weeks beginning 84 days before radical prostatectomy or standard of care arms.

Conditions

Prostate Cancer

Keywords

enoblituzumab

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival (RFS)

  Number of participants with RFS, defined as from randomization to any metastasis events, pelvic lymph node recurrence, detectable prostate-specific antigen (PSA) (PSA \>= 0.2 ng/mL, confirmed by a second PSA of the same level or higher), or start of salvage or adjuvant therapy based on PSA criteria of 0.1 ng/mL or higher, or death for any cause, whichever occurs first.

  3 years post-prostatectomy

Secondary Outcomes (12)

• Time to PSA recurrence

  5 years post-prostatectomy

• Overall survival

  5 years post-prostatectomy

• Metastasis-free survival

  5 years post-prostatectomy

• PSA response

  3 months post-prostatectomy.

• Recurrence free survival

  3 years from randomization

Other Outcomes (15)

• Quality of life assessment

  6 months from randomization

• Quantify B7-H3 IHC expression

  5 years post-prostatectomy

• Quantify checkpoint IHC expression

  Day 84

Study Arms (2)

Enoblituzumab

EXPERIMENTAL

Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV every 2 weeks for 12 weeks, followed by a radical prostatectomy on day 84, with follow-up visits 30 days, 90 days, 6 months, and 9 months post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy.

Drug: Enoblituzumab

Standard of Care

ACTIVE COMPARATOR

Patients will undergo standard of care radical prostatectomy within 4-8 weeks of randomization.

Other: Standard of Care

Interventions

Enoblituzumab DRUG

Enoblituzumab 15mg/kg IV (in the vein) every 2 weeks for 12 weeks prior to radical prostatectomy on day 84.

Also known as: MGA271

Enoblituzumab

Standard of Care OTHER

Radical prostatectomy within 4-8 weeks of randomization.

Standard of Care

Eligibility Criteria

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

You may qualify if:

• To be eligible for this study, patients must meet all of the following criteria:
• Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs by CT or NM bone scan. N1 by PSMA allowed with up to 3 LNs each ≤1 cm. If there is no frank bone disease, but PSMA scan and CT scan are in discordance, then investigators will discuss.
• Initial prostate biopsy, obtained within 3 months of enrollment, is available for central pathologic review, and is confirmed to show at least 3 positive cores (at least 1 core with at least 50% disease involvement with ≥4+3=7 disease) and a Gleason sum of ≥8 (or 4+3=7 with at least 1 additional high-risk feature such as PSA\>20 or cT3)
• Radical prostatectomy has been scheduled
• Age ≥18 years
• ECOG performance status 0-1, or Karnofsky score ≥ 70% (see Appendix A)
• Adequate bone marrow, hepatic, and renal function:
• WBC \>3,000 cells/mm3
• ANC \>1,500 cells/mm3
• Hemoglobin \>9.0 g/dL
• Platelet count \>100,000 cells/mm3
• Serum creatinine \<1.5 × upper limit of normal (ULN)
• Serum bilirubin \<1.5 × ULN
• ALT \<3 × ULN
• AST \<3 × ULN

You may not qualify if:

• To be eligible for this study, patients should not meet any of the following criteria:
• Presence of known lymph node involvement on CT (N1 by PSMA allowed with up to 3 LNs each ≤1 cm) or distant metastases by CT and NM bone scan
• Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors
• Prior radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for prostate cancer
• Prior immunotherapy/vaccine therapy for prostate cancer
• Prior use of experimental agents for prostate cancer
• Concomitant treatment with other hormonal therapy or 5α-reductase inhibitors
• Current use of systemic corticosteroids or use of systemic corticosteroids within 4 weeks of enrollment (inhaled corticosteroids for asthma or COPD are permitted as are other non-systemic steroids such as topical corticosteroids)
• History or presence of autoimmune disease requiring systemic immunosuppression (including but not limited to: inflammatory bowel disease, systemic lupus erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis, hemolytic anemia, Sjögren syndrome, and sarcoidosis)
• History of malignancy within the last 3 years, with the exception of non-melanoma skin cancers and superficial bladder cancer
• Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate
• Known prior or current history of HIV and/or hepatitis B/C, with the exception of patients who have been successfully treated for hepatitis B/C (i.e. documented confirmation of cure at least 6 months after initial treatment).

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• MacroGenics: collaborator

Study Sites (5)

Northewestern University

Chicago, Illinois, 60611, United States

RECRUITING

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21205, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55414, United States

NOT YET RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

XCancer - Omaha, LLC

Omaha, Nebraska, 68130, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Eugene Shenderov

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Chapman GU oncology

CONTACT

4109551239; cchapma7@jhmi.edu

Carolyn Chapman, RN

CONTACT

443-287-7841

Study Design

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

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 28, 2023
• Study Start: February 16, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (5)