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Prostate CancerPhase 2NCT02923180

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

A Phase 2 study testing Enoblituzumab in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Enoblituzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
14 Feb 2017to Jul 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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
  • The etiology of abnormal bilirubin and transaminase levels should be evaluated prior to study entry.
  • Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)
  • Willingness to use barrier contraception from the time of first dose of MGA271 until the time of prostatectomy.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: A Phase II Trial of Neoadjuvant Enoblituzumab (MGA271) in Men With Localized Intermediate- and High-Risk Prostate Cancer

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.

Read the detailed description

This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant MGA271 given prior to radical prostatectomy in men with intermediate and high-risk localized prostate cancer. Eligible patients will receive MGA271 at a dose of 15mg/kg IV given weekly for 6 doses beginning 50 days prior to radical prostatectomy. 14 days after the last dose of MGA271, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Follow-up evaluation for adverse events will occur 30 days and 90 days after surgery. Patients will then be followed by their urologists according to standard institutional practices, but will require PSA evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.

In Amendment 1, the study was expanded to enroll an additional 16 patients for a total of 32 patients to continue evaluating safety and better estimate the clinical benefit of Enoblituzumab in terms of undetectable PSA level (<0.1 ng/mL) at 12 months following radical prostatectomy.

Conditions
Prostate Cancer
Being tested
Enoblituzumab
Keywords
enobilituzumab
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnoblituzumabDrug

    Also called MGA271

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

Study groups in NCT02923180
Study groupRoleWhat they receive
EnoblituzumabExperimentalMen 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.
Receives: Drug: Enoblituzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

  2. 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

    Measured: 12 months

Secondary outcomes (13)

  1. Quantify Markers of Apoptosis in Prostate Tumor Specimens of Treated Patients

    Quantify markers of apoptosis in prostate tumor specimens of treated patients using TUNEL staining and expressed as the mean staining percentage in tumor tissue

    Measured: up to 5 years post-prostatectomy

  2. Mean Staining Percentage of Markers of Cell Proliferation

    Quantify markers of cell proliferation in prostate tumor specimens of treated patients using Ki-67 staining and expressed by the mean staining percentage in tumor tissue

    Measured: 3 years post-prostatectomy

  3. CD8+ T Cell Infiltration

    Mean staining percentage of CD8+ T-cells in harvested prostate glands from treated patients

    Measured: 3 years post-prostatectomy

  4. PD-L1 Expression

    Mean staining percentage of PD-L1 in tumor tissue, assessed by immunohistochemistry (IHC) in the primary core specimens (pre-treatment) and the prostatectomy surgical specimens (post-treatment).

    Measured: 3 years post-prostatectomy

  5. Regulatory T Cell (Treg) Infiltration

    Mean staining percentage of Treg cells in tumor tissue of treated patients, assessed through immunohistochemistry.

    Measured: 3 years post-prostatectomy

  6. CD4+ T Cell Infiltration

    Mean staining percentage of CD4+ T-cells in tumor tissue of treated patients, assessed through immunohistochemistry.

    Measured: 3 years post-prostatectomy

  7. Natural Killer (NK) Cell Density

    Mean staining percentage of NK cells in harvested prostate glands.

    Measured: 3 years post-prostatectomy

  8. Enoblituzumab (MGA271) Drug Distribution Evaluated by Detection of MGA271 in Tumor Tissue

    Number of participants with positive or negative MGA271 detection in post-treatment prostate tumor specimens, as evaluated by IHC of fresh frozen sections.

    Measured: 3 years

  9. Pathological Complete Responses (pCR)

    Number of participants who achieve pCR, defined as absence of tumor identification on standard histological analysis of resected prostate specimens.

    Measured: 3 years

  10. PSA Response Rates

    Number of participants with undetectable PSA (<0.1 ng/mL) at 3 months after prostatectomy.

    Measured: 3 months post-prostatectomy

  11. Time to PSA Recurrence

    Median time (months) from prostatectomy to time when PSA is ≥ 0.2 ng/mL. Estimated using Kaplan-Meier method.

    Measured: up to 37 months post-prostatectomy

  12. Gleason Grade Group Change

    Number of participants with change in Gleason grade group from pre-treatment biopsy vs. post-treatment biopsy. "Downgrade" refers to a net grade group change less than zero, "upgrade" refers to net grade group change more than zero, and "no change" refers to stable Gleason grade group. Gleason grade groups are defined as grade group 1 (Gleason score ≤ 6), grade group 2 (Gleason score 3+4=7), grade group 3 (Gleason score 4+3=7), grade group 4 (Gleason score 8), and grade group 5 (Gleason scores 9-10).The lower the grade group, the better the outcome.

    Measured: Day 50

  13. Number of Participants With PSA Percentage Decrease Prior to Radical Prostatectomy.

    The PSA percentage change is calculated as the difference from the PSA at day 50 prior to prostatectomy and PSA at screening. A negative value of PSA percentage change ("PSA percentage < 0") indicates a decrease in PSA from screening, and a positive value (PSA percentage change >= 0) indicates an increase in PSA from screening.

    Measured: 50 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2016 (estimated)
  2. Study start14 Feb 2017
  3. Primary completion11 Aug 2020
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02923180
Sponsor's protocol ID
J1693
Other IDs
IRB00103776
Status last verified
Jul 2026
First submitted
9 Sep 2016
Last updated
21 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37012549

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enoblituzumab in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-related Adverse Events (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02923180, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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