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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 (Jun 2026). This Phase 2 trial studies Enoblituzumab for prostate cancer.

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

Treatments studied

Other

Enoblituzumab

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

Demographics

Male only

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 →

Frequently asked questions

Is NCT06014255 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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