Neoadjuvant Enoblituzumab (MGA271) in Men With Localized Intermediate and High-Risk Prostate Cancer

NCT02923180 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 2 other identifiers: J1693IRB00103776
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety, anti-tumor effect, and immunogenicity of Enoblituzumab given before radical prostatectomy. All patients will receive Enoblituzumab for 6 weekly doses beginning 50 days prior to radical prostatectomy.

Conditions

Prostate Cancer

Keywords

enobilituzumab

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-related Adverse Events

  Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE)v4.0

  2 years

• Efficacy of Neoadjuvant Enoblituzumab as Assessed by PSA0 Response Rate

  Number of participants with undetectable Prostate Specific Antigen (PSA \<0.1 ng/mL) at 12 months following radical prostatectomy

  12 months

Secondary Outcomes (13)

• Quantify Markers of Apoptosis in Prostate Tumor Specimens of Treated Patients

  up to 5 years post-prostatectomy

• Mean Staining Percentage of Markers of Cell Proliferation

  3 years post-prostatectomy

• CD8+ T Cell Infiltration

  3 years post-prostatectomy

• PD-L1 Expression

  3 years post-prostatectomy

• Regulatory T Cell (Treg) Infiltration

  3 years post-prostatectomy

Other Outcomes (10)

• Androgen Receptor (AR) Quantification

  up to 3 years post-prostatectomy

• Tissue Androgen Concentrations

  up to 3 years post prostatectomy

• Global Expression Profiling of Tumor Tissues

  up to 3 years post-prostatectomy

Study Arms (1)

Enoblituzumab

EXPERIMENTAL

Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV weekly for 6 weeks followed by radical prostatectomy on day 50, with follow-up visits 30 days and 90 days post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy.

Drug: Enoblituzumab

Interventions

Enoblituzumab DRUG

Enoblituzumab 15mg/kg IV (in the vein) weekly for 6 doses beginning 50 days prior to radical prostatectomy.

Also known as: MGA271

Enoblituzumab

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs
• Initial prostate biopsy is available for central pathologic review, and is confirmed to show at least 2 positive cores and a Gleason sum of ≥7
• Radical prostatectomy has been scheduled at Johns Hopkins Hospital
• 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
• Alkaline phosphatase \<3 × ULN

You may not qualify if:

• Presence of known lymph node involvement or distant metastases
• 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

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Shenderov E, De Marzo AM, Lotan TL, Wang H, Chan S, Lim SJ, Ji H, Allaf ME, Chapman C, Moore PA, Chen F, Sorg K, White AM, Church SE, Hudson B, Fields PA, Hu S, Denmeade SR, Pienta KJ, Pavlovich CP, Ross AE, Drake CG, Pardoll DM, Antonarakis ES. Neoadjuvant enoblituzumab in localized prostate cancer: a single-arm, phase 2 trial. Nat Med. 2023 Apr;29(4):888-897. doi: 10.1038/s41591-023-02284-w. Epub 2023 Apr 3.

  PMID: 37012549 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Emmanuel Antonarakis
• Organization: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

eantona1@jhmi.edu

410-502-8341

Study Officials

• Eugene Shenderov, MD, PhD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: October 4, 2016
• Study Start: February 14, 2017
• Primary Completion: August 11, 2020
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 22, 2025
• Results First Posted: August 24, 2021

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)