Trial Outcomes & Findings for Neoadjuvant Enoblituzumab (MGA271) in Men With Localized Intermediate and High-Risk Prostate Cancer (NCT NCT02923180)

NCT ID: NCT02923180

Last Updated: 2025-07-22

Results Overview

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

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2025-07-22

Participant Flow

33 subjects signed consent to be screened for eligibility. - 1 subject signed consent, but did not meet the eligibility criteria to start the study (screen failure)

Participant milestones

Measure	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.
Overall Study STARTED	32
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Measure	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.
Overall Study Off Study Due to Detectable PSA	13
Overall Study Remaining in Long Term Follow Up for PSA	13

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Enoblituzumab n=32 Participants 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.
Age, Continuous	65 years STANDARD_DEVIATION 5.82 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Smoking History Yes	9 Participants n=5 Participants
Smoking History No	23 Participants n=5 Participants
Family History of Prostate Cancer Yes	7 Participants n=5 Participants
Family History of Prostate Cancer No	25 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) performance status 0	31 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) performance status 1	1 Participants n=5 Participants
Body-mass index (kg/m^2) Normal (BMI 18.5 - 24.9)	6 Participants n=5 Participants
Body-mass index (kg/m^2) Overweight (BMI 25.0 - 29.9)	14 Participants n=5 Participants
Body-mass index (kg/m^2) Obese (BMI ≥ 30.0)	12 Participants n=5 Participants
Gleason Group / Gleason sum at biopsy Grade Group 3: 4+3	5 Participants n=5 Participants
Gleason Group / Gleason sum at biopsy Grade Group 4: 4+4	8 Participants n=5 Participants
Gleason Group / Gleason sum at biopsy Grade Group 5: 4+5, 5+4, or 5+5	19 Participants n=5 Participants
Previous Therapy	0 Participants n=5 Participants
Stage T3 at initial diagnosis Yes	23 Participants n=5 Participants
Stage T3 at initial diagnosis No	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

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

Outcome measures

Measure	Enoblituzumab n=32 Participants 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.
Number of Participants With Treatment-related Adverse Events Grade 1	31 Participants
Number of Participants With Treatment-related Adverse Events Grade 2	12 Participants
Number of Participants With Treatment-related Adverse Events Grade 3	4 Participants
Number of Participants With Treatment-related Adverse Events Grade 4	0 Participants

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Enoblituzumab n=32 Participants 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.
Efficacy of Neoadjuvant Enoblituzumab as Assessed by PSA0 Response Rate PSA < 0.1 ng/mL	21 Participants
Efficacy of Neoadjuvant Enoblituzumab as Assessed by PSA0 Response Rate PSA ≥ 0.1 ng/mL	11 Participants

SECONDARY outcome

Timeframe: up to 5 years post-prostatectomy

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years post-prostatectomy

Population: Only 30 of the 32 participants enrolled in the trial had evaluable tissue samples.

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

Outcome measures

Measure	Enoblituzumab n=30 Participants 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.
Mean Staining Percentage of Markers of Cell Proliferation	11.92 staining percentage Standard Deviation 0.82

SECONDARY outcome

Timeframe: 3 years post-prostatectomy

Population: Only 30 of the 32 participants enrolled in the trial had evaluable tissue samples.

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

Outcome measures

Measure	Enoblituzumab n=30 Participants 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.
CD8+ T Cell Infiltration	11.68 staining percentage Standard Deviation 0.71

SECONDARY outcome

Timeframe: 3 years post-prostatectomy

Population: Only 30 of the 32 participants enrolled in the trial had evaluable tissue samples.

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).

Outcome measures

Measure	Enoblituzumab n=30 Participants 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.
PD-L1 Expression	10.66 staining percentage Standard Deviation 0.82

SECONDARY outcome

Timeframe: 3 years post-prostatectomy

Population: Only 30 of the 32 participants enrolled in the trial had evaluable tissue samples.

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

Outcome measures

Measure	Enoblituzumab n=30 Participants 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.
Regulatory T Cell (Treg) Infiltration	9.36 staining percentage Standard Deviation 0.9

SECONDARY outcome

Timeframe: 3 years post-prostatectomy

Population: Only 30 of the 32 participants enrolled in the trial had evaluable tissue samples.

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

Outcome measures

Measure	Enoblituzumab n=30 Participants 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.
CD4+ T Cell Infiltration	11.68 staining percentage Standard Deviation 0.71

SECONDARY outcome

Timeframe: 3 years post-prostatectomy

Population: Only 30 of the 32 participants enrolled in the trial had evaluable tissue samples.

Mean staining percentage of NK cells in harvested prostate glands.

Outcome measures

Measure	Enoblituzumab n=30 Participants 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.
Natural Killer (NK) Cell Density	11.92 staining percentage Standard Deviation 0.82

SECONDARY outcome

Timeframe: 3 years

Population: The Overall Number of Participants Analyzed represents those evaluable for this outcome. Of the 32 participants who received study treatment, data from 2 subjects was not evaluable.

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

Outcome measures

Measure	Enoblituzumab n=30 Participants 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.
Enoblituzumab (MGA271) Drug Distribution Evaluated by Detection of MGA271 in Tumor Tissue Positive	28 Participants
Enoblituzumab (MGA271) Drug Distribution Evaluated by Detection of MGA271 in Tumor Tissue Negative	2 Participants

SECONDARY outcome

Timeframe: 3 years

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

Outcome measures

Measure	Enoblituzumab n=32 Participants 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.
Pathological Complete Responses (pCR)	0 Participants

SECONDARY outcome

Timeframe: 3 months post-prostatectomy

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

Outcome measures

Measure	Enoblituzumab n=32 Participants 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.
PSA Response Rates PSA <0.1 ng/mL	26 Participants
PSA Response Rates PSA ≥0.1 ng/mL	6 Participants

SECONDARY outcome

Timeframe: up to 37 months post-prostatectomy

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

Outcome measures

Measure	Enoblituzumab n=32 Participants 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.
Time to PSA Recurrence	30 months Interval 3.0 to 37.0

SECONDARY outcome

Timeframe: Day 50

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.

Outcome measures

Measure	Enoblituzumab n=32 Participants 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.
Gleason Grade Group Change Downgrade (< 0 net grade group change)	16 Participants
Gleason Grade Group Change No Change (= 0 net grade group change)	12 Participants
Gleason Grade Group Change Upgrade (> 0 net grade group change)	4 Participants

SECONDARY outcome

Timeframe: 50 Days

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.

Outcome measures

Measure	Enoblituzumab n=32 Participants 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.
Number of Participants With PSA Percentage Decrease Prior to Radical Prostatectomy. PSA percentage change < 0	16 Participants
Number of Participants With PSA Percentage Decrease Prior to Radical Prostatectomy. PSA percentage change >= 0	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 3 years post-prostatectomy

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 3 years post prostatectomy

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 3 years post-prostatectomy

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 3 years post-prostatectomy

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years post-prostatectomy

Population: Only 30 of the 32 participants enrolled in the trial had evaluable samples.

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

Outcome measures

Measure	Enoblituzumab n=30 Participants 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.
TCR Repertoire Number of participants with 100% peripheral expanded clones associated with tumor	7 Participants
TCR Repertoire Number of participants with 99% or less peripheral expanded clones associated with tumor	23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 3 years post-prostatectomy

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years post-prostatectomy

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years post-prostatectomy

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).

Outcome measures

Measure	Enoblituzumab n=32 Participants 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.
B7-H3 Expression	28 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Years post-prostatectomy

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years post-prostatectomy

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

Outcome measures

Measure	Enoblituzumab n=32 Participants 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.
Quantify Antigen-spread Number of participants with IgG reactivity	1 Participants
Quantify Antigen-spread Number of participants with IgM reactivity	1 Participants
Quantify Antigen-spread Number of participants without antigen reactivity	30 Participants

Adverse Events

Enoblituzumab

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Enoblituzumab n=32 participants at risk 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.
Immune system disorders Infusion related reaction	3.1% 1/32 • 2 years
Blood and lymphatic system disorders Ascites	3.1% 1/32 • 2 years
Cardiac disorders Pericardial Effusion	3.1% 1/32 • 2 years
Cardiac disorders Cardiac Disorders - Other, Non-ST-Elevation, Myocardial Infarction	3.1% 1/32 • 2 years
Cardiac disorders Atrial Fibrillation	3.1% 1/32 • 2 years
Cardiac disorders Pericarditis	3.1% 1/32 • 2 years
Cardiac disorders Myocarditis	3.1% 1/32 • 2 years

Other adverse events

Measure	Enoblituzumab n=32 participants at risk 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.
General disorders Fatigue	71.9% 23/32 • Number of events 34 • 2 years
Metabolism and nutrition disorders Hyponatremia	3.1% 1/32 • Number of events 1 • 2 years
Infections and infestations Upper respiratory infection	12.5% 4/32 • Number of events 4 • 2 years
Respiratory, thoracic and mediastinal disorders Cough	12.5% 4/32 • Number of events 6 • 2 years
Blood and lymphatic system disorders Anemia	15.6% 5/32 • Number of events 7 • 2 years
Metabolism and nutrition disorders Hypocalcemia	9.4% 3/32 • Number of events 3 • 2 years
Renal and urinary disorders Urinary incontinence	96.9% 31/32 • Number of events 31 • 2 years
General disorders Flu like symptoms	40.6% 13/32 • Number of events 17 • 2 years
Nervous system disorders Headache	40.6% 13/32 • Number of events 14 • 2 years
Musculoskeletal and connective tissue disorders Pain in extremity	28.1% 9/32 • Number of events 9 • 2 years
General disorders Edema limbs	12.5% 4/32 • Number of events 5 • 2 years
Musculoskeletal and connective tissue disorders Arthralgia	18.8% 6/32 • Number of events 8 • 2 years
Gastrointestinal disorders Abdominal pain	15.6% 5/32 • Number of events 5 • 2 years
Investigations White blood cell decreased	3.1% 1/32 • Number of events 1 • 2 years
Renal and urinary disorders Erectile dysfunction	37.5% 12/32 • Number of events 12 • 2 years
Investigations Creatinine increased	9.4% 3/32 • Number of events 7 • 2 years
Investigations CD4 lymphocytes decreased	3.1% 1/32 • Number of events 1 • 2 years
Investigations Aspartate aminotransferase increased	3.1% 1/32 • Number of events 1 • 2 years
Investigations Alanine aminotransferase increased	3.1% 1/32 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Nasal congestion	15.6% 5/32 • Number of events 5 • 2 years
General disorders Chills	28.1% 9/32 • Number of events 10 • 2 years
Gastrointestinal disorders Vomiting	15.6% 5/32 • Number of events 5 • 2 years
General disorders Fever	25.0% 8/32 • Number of events 9 • 2 years
Metabolism and nutrition disorders Hypoalbuminemia	3.1% 1/32 • Number of events 1 • 2 years
Investigations Serum amylase increased	12.5% 4/32 • Number of events 7 • 2 years
Musculoskeletal and connective tissue disorders Neck pain	3.1% 1/32 • Number of events 1 • 2 years
Metabolism and nutrition disorders Anorexia	12.5% 4/32 • Number of events 4 • 2 years
Injury, poisoning and procedural complications Bruising	6.2% 2/32 • Number of events 2 • 2 years
Musculoskeletal and connective tissue disorders Left knee weakness	3.1% 1/32 • Number of events 1 • 2 years
Investigations Lipase increased	6.2% 2/32 • Number of events 4 • 2 years
Gastrointestinal disorders Constipation	6.2% 2/32 • Number of events 2 • 2 years
Gastrointestinal disorders Nausea	25.0% 8/32 • Number of events 10 • 2 years
General disorders Infusion related reaction	18.8% 6/32 • Number of events 7 • 2 years
Skin and subcutaneous tissue disorders IV infiltration	3.1% 1/32 • Number of events 1 • 2 years
Injury, poisoning and procedural complications Seroma	9.4% 3/32 • Number of events 3 • 2 years
Skin and subcutaneous tissue disorders Rash maculo-papular	9.4% 3/32 • Number of events 4 • 2 years
Respiratory, thoracic and mediastinal disorders Cold symptoms	3.1% 1/32 • Number of events 1 • 2 years
Nervous system disorders Dizziness	6.2% 2/32 • Number of events 2 • 2 years
Gastrointestinal disorders Diarrhea	6.2% 2/32 • Number of events 2 • 2 years
Investigations Weight gain	6.2% 2/32 • Number of events 2 • 2 years
Skin and subcutaneous tissue disorders Pruritus	6.2% 2/32 • Number of events 2 • 2 years
Investigations Blood bilirubin increased	6.2% 2/32 • Number of events 2 • 2 years
Nervous system disorders Paresthesia	6.2% 2/32 • Number of events 2 • 2 years
Eye disorders Right eye stye	3.1% 1/32 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.1% 1/32 • Number of events 1 • 2 years
Respiratory, thoracic and mediastinal disorders Sore throat	3.1% 1/32 • Number of events 1 • 2 years
Renal and urinary disorders Dysuria	9.4% 3/32 • Number of events 3 • 2 years
Gastrointestinal disorders Dry mouth	3.1% 1/32 • Number of events 1 • 2 years
Renal and urinary disorders Urinary retention	6.2% 2/32 • Number of events 3 • 2 years
Gastrointestinal disorders Ascites	3.1% 1/32 • Number of events 1 • 2 years
Gastrointestinal disorders Abdominal distension	3.1% 1/32 • Number of events 1 • 2 years
Renal and urinary disorders Acute kidney injury	3.1% 1/32 • Number of events 1 • 2 years
Metabolism and nutrition disorders Hyperkalemia	3.1% 1/32 • Number of events 2 • 2 years
Renal and urinary disorders Leukocyturia	3.1% 1/32 • Number of events 1 • 2 years
Renal and urinary disorders Hemoglobinuria	3.1% 1/32 • Number of events 1 • 2 years
Injury, poisoning and procedural complications Bladder anastomotic leak	3.1% 1/32 • Number of events 1 • 2 years
Musculoskeletal and connective tissue disorders Back pain	9.4% 3/32 • Number of events 4 • 2 years
Renal and urinary disorders Hematuria	6.2% 2/32 • Number of events 2 • 2 years
Vascular disorders Lymphocele	3.1% 1/32 • Number of events 1 • 2 years
Skin and subcutaneous tissue disorders Skin infection	3.1% 1/32 • Number of events 1 • 2 years
Cardiac disorders Atrial fibrillation	3.1% 1/32 • Number of events 1 • 2 years
Renal and urinary disorders Discolored urine	3.1% 1/32 • Number of events 1 • 2 years
Eye disorders Eye pain	6.2% 2/32 • Number of events 2 • 2 years
Renal and urinary disorders Urinary frequency	6.2% 2/32 • Number of events 3 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea	3.1% 1/32 • Number of events 1 • 2 years
Vascular disorders Flushing	3.1% 1/32 • Number of events 1 • 2 years
Immune system disorders Allergic reaction	3.1% 1/32 • Number of events 2 • 2 years
Cardiac disorders Pericarditis	3.1% 1/32 • Number of events 2 • 2 years
Cardiac disorders Myocarditis	3.1% 1/32 • Number of events 2 • 2 years
Cardiac disorders Pericardial effusion	3.1% 1/32 • Number of events 2 • 2 years
Surgical and medical procedures Loss of dental filling	3.1% 1/32 • Number of events 1 • 2 years
Gastrointestinal disorders Gastroesophageal reflux disease	3.1% 1/32 • Number of events 1 • 2 years
Musculoskeletal and connective tissue disorders Left meniscus tear/injury	3.1% 1/32 • Number of events 1 • 2 years
Cardiac disorders Hypotension	6.2% 2/32 • Number of events 2 • 2 years
Gastrointestinal disorders Bloating	3.1% 1/32 • Number of events 1 • 2 years
Investigations Platelet count decreased	3.1% 1/32 • Number of events 1 • 2 years
Vascular disorders Tachycardia	3.1% 1/32 • Number of events 1 • 2 years
Renal and urinary disorders Urinary tract infection	3.1% 1/32 • Number of events 1 • 2 years
Skin and subcutaneous tissue disorders Incision site tenderness and erythema	3.1% 1/32 • Number of events 1 • 2 years
Gastrointestinal disorders Dysgeusia	3.1% 1/32 • Number of events 1 • 2 years

Additional Information

Dr. Emmanuel Antonarakis

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Phone: 410-502-8341

Email: eantona1@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place