Active, not recruitingNCT02923180Updated Aug 21, 2026Results posted

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

A Phase 2 interventional study of Enoblituzumab in Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Active, not recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 33
Allocation: Not applicable
Ages: 18 Years and older
Sex: Male

Study 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 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 studied

Prostate Cancer

Browse trials for

Prostatic Neoplasms 6,370

Keywords

enobilituzumab

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 33 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

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
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.

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 33 participants (actual)

Study arms

Experimental
Enoblituzumab
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

DrugEnoblituzumab
Enoblituzumab 15mg/kg IV (in the vein) weekly for 6 doses beginning 50 days prior to radical prostatectomy.
Also known as: MGA271

What researchers measure

Primary outcomes

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
Time frame: 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
Time frame: 12 months

Secondary outcomes

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
Time frame: up to 5 years post-prostatectomy
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
Time frame: 3 years post-prostatectomy
CD8+ T Cell Infiltration
Mean staining percentage of CD8+ T-cells in harvested prostate glands from treated patients
Time frame: 3 years post-prostatectomy
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).
Time frame: 3 years post-prostatectomy
Regulatory T Cell (Treg) Infiltration
Mean staining percentage of Treg cells in tumor tissue of treated patients, assessed through immunohistochemistry.
Time frame: 3 years post-prostatectomy
CD4+ T Cell Infiltration
Mean staining percentage of CD4+ T-cells in tumor tissue of treated patients, assessed through immunohistochemistry.
Time frame: 3 years post-prostatectomy
Natural Killer (NK) Cell Density
Mean staining percentage of NK cells in harvested prostate glands.
Time frame: 3 years post-prostatectomy
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.
Time frame: 3 years
Pathological Complete Responses (pCR)
Number of participants who achieve pCR, defined as absence of tumor identification on standard histological analysis of resected prostate specimens.
Time frame: 3 years
PSA Response Rates
Number of participants with undetectable PSA (\<0.1 ng/mL) at 3 months after prostatectomy.
Time frame: 3 months post-prostatectomy
Time to PSA Recurrence
Median time (months) from prostatectomy to time when PSA is ≥ 0.2 ng/mL. Estimated using Kaplan-Meier method.
Time frame: up to 37 months post-prostatectomy
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.
Time frame: Day 50
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.
Time frame: 50 Days

Other outcomes

Androgen Receptor (AR) Quantification
Mean staining percentage of AR in harvested prostate tissue, assessed by immunohistochemistry (IHC) staining for AR protein.
Time frame: up to 3 years post-prostatectomy
Tissue Androgen Concentrations
Concentration (picogram/3 mg) of testosterone and 5α-dihydrotestosterone (DHT) in prostate tissue.
Time frame: up to 3 years post prostatectomy
Global Expression Profiling of Tumor Tissues
Number of participants with changes in cellular composition, upregulation and downregulation of immune checkpoints, and other markers of activity versus exhaustion.
Time frame: up to 3 years post-prostatectomy
IHC Analyses of CD137, CD16 and/or CD107A
CD137, CD107A, and CD16 expression in prostate tumor specimens will be assessed by immunohistochemistry (IHC) in the prostatectomy surgical specimens (post-treatment). This endpoint will be expressed as the mean staining percentage of each of these in tumor tissue
Time frame: up to 3 years post-prostatectomy
TCR Repertoire
Fraction of peripherally expanded clones that are tumor associated for each participant.
Time frame: 3 years post-prostatectomy
FC Receptor Genotyping
Number of participants with CD16A, CD32A, and CD32B on Fc receptor.
Time frame: up to 3 years post-prostatectomy
PBLs
Number of participants with upregulation and downregulation of immune checkpoints and other markers of activity versus exhaustion, as assessed by flow cytometry at treatment day 1 (pre-treatment), treatment day 36 (post-treatment), and 30 days post-prostatectomy.
Time frame: 3 years post-prostatectomy
B7-H3 Expression
Number of participants with B7-H3 expression in prostate tumor specimens will be assessed by IHC (immunohistochemistry) in the primary core specimens (pre-treatment) and in the prostatectomy surgical specimens (post-treatment).
Time frame: 3 years post-prostatectomy
PD-1, LAG3, and TIM3 Expression
PD-1, LAG3, and TIM3 expression in prostate tumor specimens will be assessed by IHC (immunohistochemistry) in the primary core specimens (pre-treatment) and in the prostatectomy surgical specimens (post-treatment). This endpoint will be expressed as the mean staining percentage in tumor tissue.
Time frame: 3 Years post-prostatectomy
Quantify Antigen-spread
Number of participants with antigen-spread to on-target and off-target antigens.
Time frame: 3 years post-prostatectomy

Results

Posted Aug 24, 2021

Participant flow

Participant flow — Overall Study
Milestone	Enoblituzumab
Started	32
Completed	6
Not completed	26
Withdrew: Off study due to detectable psa	13
Withdrew: Remaining in long term follow up for psa	13

Outcome measures

PrimaryNumber 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

Time frame:: 2 years
Reported as:: Count of participants · Participants

Number of Participants With Treatment-related Adverse Events
Participants	Enoblituzumab
Grade 1	31
Grade 2	12
Grade 3	4
Grade 4	0

PrimaryEfficacy 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

Time frame:: 12 months
Reported as:: Count of participants · Participants

Efficacy of Neoadjuvant Enoblituzumab as Assessed by PSA0 Response Rate
Participants	Enoblituzumab
PSA < 0.1 ng/mL	21
PSA ≥ 0.1 ng/mL	11

SecondaryQuantify 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

Time frame:: up to 5 years post-prostatectomy

Results for this outcome have not been posted.

SecondaryMean 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

Time frame:: 3 years post-prostatectomy
Reported as:: Mean · staining percentage

Mean Staining Percentage of Markers of Cell Proliferation
staining percentage	Enoblituzumab
Mean Staining Percentage of Markers of Cell Proliferation	11.92 ± 0.82

SecondaryCD8+ T Cell Infiltration

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

Time frame:: 3 years post-prostatectomy
Reported as:: Mean · staining percentage

CD8+ T Cell Infiltration
staining percentage	Enoblituzumab
CD8+ T Cell Infiltration	11.68 ± 0.71

SecondaryPD-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).

Time frame:: 3 years post-prostatectomy
Reported as:: Mean · staining percentage

PD-L1 Expression
staining percentage	Enoblituzumab
PD-L1 Expression	10.66 ± 0.82

SecondaryRegulatory T Cell (Treg) Infiltration

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

Time frame:: 3 years post-prostatectomy
Reported as:: Mean · staining percentage

Regulatory T Cell (Treg) Infiltration
staining percentage	Enoblituzumab
Regulatory T Cell (Treg) Infiltration	9.36 ± 0.9

SecondaryCD4+ T Cell Infiltration

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

Time frame:: 3 years post-prostatectomy
Reported as:: Mean · staining percentage

CD4+ T Cell Infiltration
staining percentage	Enoblituzumab
CD4+ T Cell Infiltration	11.68 ± 0.71

SecondaryNatural Killer (NK) Cell Density

Mean staining percentage of NK cells in harvested prostate glands.

Time frame:: 3 years post-prostatectomy
Reported as:: Mean · staining percentage

Natural Killer (NK) Cell Density
staining percentage	Enoblituzumab
Natural Killer (NK) Cell Density	11.92 ± 0.82

SecondaryEnoblituzumab (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.

Time frame:: 3 years
Reported as:: Count of participants · Participants

Enoblituzumab (MGA271) Drug Distribution Evaluated by Detection of MGA271 in Tumor Tissue
Participants	Enoblituzumab
Positive	28
Negative	2

SecondaryPathological Complete Responses (pCR)

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

Time frame:: 3 years
Reported as:: Count of participants · Participants

Pathological Complete Responses (pCR)
Participants	Enoblituzumab
Pathological Complete Responses (pCR)	0

SecondaryPSA Response Rates

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

Time frame:: 3 months post-prostatectomy
Reported as:: Count of participants · Participants

PSA Response Rates
Participants	Enoblituzumab
PSA <0.1 ng/mL	26
PSA ≥0.1 ng/mL	6

SecondaryTime to PSA Recurrence

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

Time frame:: up to 37 months post-prostatectomy
Reported as:: Median · months

Time to PSA Recurrence
months	Enoblituzumab
Time to PSA Recurrence	30 (3 to 37)

SecondaryGleason 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.

Time frame:: Day 50
Reported as:: Count of participants · Participants

Gleason Grade Group Change
Participants	Enoblituzumab
Downgrade (< 0 net grade group change)	16
No Change (= 0 net grade group change)	12
Upgrade (> 0 net grade group change)	4

SecondaryNumber 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.

Time frame:: 50 Days
Reported as:: Count of participants · Participants

Number of Participants With PSA Percentage Decrease Prior to Radical Prostatectomy.
Participants	Enoblituzumab
PSA percentage change < 0	16
PSA percentage change >= 0	16

Other pre-specifiedAndrogen Receptor (AR) Quantification

Mean staining percentage of AR in harvested prostate tissue, assessed by immunohistochemistry (IHC) staining for AR protein.

Time frame:: up to 3 years post-prostatectomy

Results for this outcome have not been posted.

Other pre-specifiedTissue Androgen Concentrations

Concentration (picogram/3 mg) of testosterone and 5α-dihydrotestosterone (DHT) in prostate tissue.

Time frame:: up to 3 years post prostatectomy

Results for this outcome have not been posted.

Other pre-specifiedGlobal Expression Profiling of Tumor Tissues

Number of participants with changes in cellular composition, upregulation and downregulation of immune checkpoints, and other markers of activity versus exhaustion.

Time frame:: up to 3 years post-prostatectomy

Results for this outcome have not been posted.

Other pre-specifiedIHC Analyses of CD137, CD16 and/or CD107A

CD137, CD107A, and CD16 expression in prostate tumor specimens will be assessed by immunohistochemistry (IHC) in the prostatectomy surgical specimens (post-treatment). This endpoint will be expressed as the mean staining percentage of each of these in tumor tissue

Time frame:: up to 3 years post-prostatectomy

Results for this outcome have not been posted.

Other pre-specifiedTCR Repertoire

Fraction of peripherally expanded clones that are tumor associated for each participant.

Time frame:: 3 years post-prostatectomy
Reported as:: Count of participants · Participants

TCR Repertoire
Participants	Enoblituzumab
Number of participants with 100% peripheral expanded clones associated with tumor	7
Number of participants with 99% or less peripheral expanded clones associated with tumor	23

Other pre-specifiedFC Receptor Genotyping

Number of participants with CD16A, CD32A, and CD32B on Fc receptor.

Time frame:: up to 3 years post-prostatectomy

Results for this outcome have not been posted.

Other pre-specifiedPBLs

Number of participants with upregulation and downregulation of immune checkpoints and other markers of activity versus exhaustion, as assessed by flow cytometry at treatment day 1 (pre-treatment), treatment day 36 (post-treatment), and 30 days post-prostatectomy.

Time frame:: 3 years post-prostatectomy

Results for this outcome have not been posted.

Other pre-specifiedB7-H3 Expression

Number of participants with B7-H3 expression in prostate tumor specimens will be assessed by IHC (immunohistochemistry) in the primary core specimens (pre-treatment) and in the prostatectomy surgical specimens (post-treatment).

Time frame:: 3 years post-prostatectomy
Reported as:: Count of participants · Participants

B7-H3 Expression
Participants	Enoblituzumab
B7-H3 Expression	28

Other pre-specifiedPD-1, LAG3, and TIM3 Expression

PD-1, LAG3, and TIM3 expression in prostate tumor specimens will be assessed by IHC (immunohistochemistry) in the primary core specimens (pre-treatment) and in the prostatectomy surgical specimens (post-treatment). This endpoint will be expressed as the mean staining percentage in tumor tissue.

Time frame:: 3 Years post-prostatectomy

Results for this outcome have not been posted.

Other pre-specifiedQuantify Antigen-spread

Number of participants with antigen-spread to on-target and off-target antigens.

Time frame:: 3 years post-prostatectomy
Reported as:: Count of participants · Participants

Quantify Antigen-spread
Participants	Enoblituzumab
Number of participants with IgG reactivity	1
Number of participants with IgM reactivity	1
Number of participants without antigen reactivity	30

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Enoblituzumab	0/32 (0%)	3/32 (9.4%)	32/32 (100%)

Most frequent serious events

Most frequent serious events
Event	Enoblituzumab
Infusion related reactionImmune system disorders	1/32
AscitesBlood and lymphatic system disorders	1/32
Pericardial EffusionCardiac disorders	1/32
Cardiac Disorders - Other, Non-ST-Elevation, Myocardial InfarctionCardiac disorders	1/32
Atrial FibrillationCardiac disorders	1/32
PericarditisCardiac disorders	1/32
MyocarditisCardiac disorders	1/32

Most frequent other events

Showing 10 of 80

Most frequent other events
Event	Enoblituzumab
Urinary incontinenceRenal and urinary disorders	31/32
FatigueGeneral disorders	23/32
Flu like symptomsGeneral disorders	13/32
HeadacheNervous system disorders	13/32
Erectile dysfunctionRenal and urinary disorders	12/32
Pain in extremityMusculoskeletal and connective tissue disorders	9/32
ChillsGeneral disorders	9/32
FeverGeneral disorders	8/32
NauseaGastrointestinal disorders	8/32
ArthralgiaMusculoskeletal and connective tissue disorders	6/32

Baseline characteristics

Participants who met eligibility criteria

Age, Continuous
Age, Continuous(years)	Enoblituzumab
Mean	65 ± 5.82

Sex: Female, Male
Sex: Female, Male(Participants)	Enoblituzumab
Female	0
Male	32

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Enoblituzumab
Hispanic or Latino	0
Not Hispanic or Latino	32
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Enoblituzumab
American Indian or Alaska Native	0
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	1
White	30
More than one race	0
Unknown or Not Reported	0

Smoking History
Smoking History(Participants)	Enoblituzumab
Yes	9
No	23

Family History of Prostate Cancer
Family History of Prostate Cancer(Participants)	Enoblituzumab
Yes	7
No	25

Eastern Cooperative Oncology Group (ECOG) performance status
Eastern Cooperative Oncology Group (ECOG) performance status(Participants)	Enoblituzumab
0	31
1	1

Body-mass index (kg/m^2)
Body-mass index (kg/m^2)(Participants)	Enoblituzumab
Normal (BMI 18.5 - 24.9)	6
Overweight (BMI 25.0 - 29.9)	14
Obese (BMI ≥ 30.0)	12

3 further baseline measures are reported on the registry.

Study locations

1 site

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21205, United States

References and documents

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 ↗

Study documents

Protocol and statistical analysis plan · Jun 8, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02923180
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: MacroGenics
Responsible party: Sponsor
First posted: Oct 4, 2016
Start date: Feb 14, 2017
Primary completion: Aug 11, 2020
Completion: Jul 2027 (estimated)
Results posted: Aug 24, 2021
Last update: Aug 21, 2026

Study contacts

Eugene Shenderov, MD, PhD

principal investigator · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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

Study summary

Conditions studied

Browse trials for

Keywords

In context

Prostatic Neoplasms

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Other outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria