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Title:
Neoadjuvant Enoblituzumab (MGA271) in Men with Localized Intermediate and High-Risk Prostate Cancer – a Pilot and Biomarker Study
Protocol Number:
J1693
Phase:
Pilot
Physician:
Emmanuel Antonarakis
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
This is a single-center, single arm, open-label pilot study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant Enoblituzumab (MGA271) administered prior to prostatectomy.The study aims to (1) investigate whether inhibition of B7-H3 via administration of Enoblituzumab is safe and feasible in the neoadjuvant setting for men with localized intermediate- and high-risk prostate cancer; (2) determine whether Enoblituzumab produces anti-tumor responses; and (3) determine whether Enoblituzumab is immunogenic in men with localized prostate cancer by evaluating T-cell infiltration in harvested prostate glands.Study hypothesizes that neoadjuvant Enoblituzumab will be feasible and safe (i.e., will not interfere with subsequent prostatectomy), and will produce measurable tumor cell death and antitumor immune responses.
Eligibility:
InclusionMen 18 and older, with intermediate- or hish-risk localized prostate cancer (without involvement of lymph nodes, bone, or visceral organs; at least 2 positive cores; and Gleason score of greater than / equal to 7) are eligible. Participants must also have adequate bone marrow, hepatic, and renal function.ExclusionPrior treatment for prostate cancer, systemic corticosteroids, autoimmune disorders requiring immunosuppression, other malignancies, and uncontrolled illnesses are not allowed.
Treatment:
Eligible patients will receive Enoblituzumab at a dose of 15mg/kg IV given weekly for 6 doses beginning 50 days prior to radical prostatectomy; 14 days after last dose of Enoblituzumab, prostate glands will be harvested at time of prostatectomy. Follow-up evaluation for adverse events will occur 30 days and 90 days after surgery, and participants will have PSA evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.
Population:
Adult
Last Update
03/05/2019 05:03 AM