Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06014255 | Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer | PHASE2 | RECRUITING | 219 | — | — | Feb 16, 2024 | Mar 1, 2029 | Oct 29, 2025 | 5 | United States |
| NCT02923180 | Neoadjuvant Enoblituzumab (MGA271) in Men With Localized Intermediate and High-Risk Prostate Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 33 | — | — | Feb 14, 2017 | Jul 1, 2026 | Jul 22, 2025 | 1 | United States |
Number of participants with RFS, defined as from randomization to any metastasis events, pelvic lymph node recurrence, detectable prostate-specific antigen (PSA) (PSA \>= 0.2 ng/mL, confirmed by a second PSA of the same level or higher), or start of salvage or adjuvant therapy based on PSA criteria of 0.1 ng/mL or higher, or death for any cause, whichever occurs first.
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE)v4.0
Number of participants with undetectable Prostate Specific Antigen (PSA \<0.1 ng/mL) at 12 months following radical prostatectomy
| Arm | Type | Description |
|---|---|---|
| Enoblituzumab | EXPERIMENTAL | Men with localized intermediate and high-risk prostate cancer will be given neoadjuvant Enoblituzumab 15mg/kg IV every 2 weeks for 12 weeks, followed by a radical prostatectomy on day 84, with follow-up visits 30 days, 90 days, 6 months, and 9 months post-prostatectomy. PSA values will be tracked for 3 years post-prostatectomy. |
| Standard of Care | ACTIVE_COMPARATOR | Patients will undergo standard of care radical prostatectomy within 4-8 weeks of randomization. |
| Name | Type | Description |
|---|---|---|
| Enoblituzumab | DRUG | Enoblituzumab 15mg/kg IV (in the vein) every 2 weeks for 12 weeks prior to radical prostatectomy on day 84. |
| Standard of Care | OTHER | Radical prostatectomy within 4-8 weeks of randomization. |
Inclusion Criteria: To be eligible for this study, patients must meet all of the following criteria: * Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs by CT or NM bone scan. N1 by PSMA allowed wit...