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OncoMatch/Clinical Trials/NCT06014255

Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer

Is NCT06014255 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Enoblituzumab for prostate cancer.

Phase 2RecruitingSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNCT06014255Data as of May 2026

Treatment: EnoblituzumabThis study evaluates the efficacy, anti-tumor effect, and immunogenicity of neoadjuvant enoblituzumab given before radical prostatectomy. Patients will be randomized to enoblituzumab for a total of 12 weeks beginning 84 days before radical prostatectomy or standard of care arms.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Grade: Gleason sum ≥8 (or 4+3=7 with at least 1 additional high-risk feature such as PSA>20 or cT3) (Gleason)

clinical stage T1c-T3b, N0, M0; Gleason sum of ≥8 (or 4+3=7 with at least 1 additional high-risk feature such as PSA>20 or cT3)

Performance status

ECOG OR KARNOFSKY 0–1

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiation therapy

Prior radiation therapy for prostate cancer

Cannot have received: hormonal therapy

Prior hormonal therapy for prostate cancer

Cannot have received: biologic therapy

Prior biologic therapy for prostate cancer

Cannot have received: chemotherapy

Prior chemotherapy for prostate cancer

Cannot have received: immunotherapy

Prior immunotherapy/vaccine therapy for prostate cancer

Cannot have received: experimental agent

Prior use of experimental agents for prostate cancer

Lab requirements

Blood counts

wbc >3,000 cells/mm3; anc >1,500 cells/mm3; hemoglobin >9.0 g/dl; platelet count >100,000 cells/mm3

Kidney function

serum creatinine <1.5 × uln

Liver function

serum bilirubin <1.5 × uln; alt <3 × uln; ast <3 × uln; alkaline phosphatase <3 × uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Northewestern University · Chicago, Illinois
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center · Baltimore, Maryland
  • University of Minnesota · Minneapolis, Minnesota
  • Mayo Clinic · Rochester, Minnesota
  • XCancer - Omaha, LLC · Omaha, Nebraska

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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