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

Sex: Male

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE2

Enrollment: 33

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Location: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland

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.

Eligibility Criteria

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02923180). StuddyBuddy aggregates publicly available trial information.