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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06551324 | A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1). | PHASE3 | ACTIVE NOT_RECRUITING | 600 | — | — | Oct 21, 2024 | Oct 29, 2028 | May 5, 2026 | 230 | United States, Argentina +21 |
| NCT07592910 | A Study of Mevrometostat With Enzalutamide in People With Prostate Cancer Who Have Previously Received Androgen Receptor Pathway Inhibitor Therapy | PHASE2 | NOT YET_RECRUITING | 60 | — | — | Aug 1, 2026 | Aug 1, 2029 | May 18, 2026 | - | — |
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.
rPFS by RECIST v1.1 and PCWG3 defined as time from start of study treatment to the earlier of first documentation of objective progressive disease by RECIST v1.1 or PCWG3 or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Investigational Arm A: PF-06821497 875 mg twice daily (BID) + enzalutamide 160 mg every day (QD) |
| Arm B | ACTIVE_COMPARATOR | Comparator Arm B: Physician's choice of enzalutamide 160 mg QD or docetaxel 75 mg/m2 intravenous (IV) every 21 days |
| Mevrometostat + Enzalutamide | EXPERIMENTAL | Mevrometostat 875 mg orally twice daily (BID) with food in combination with enzalutamide 160 mg orally once daily. Treatment continues until confirmed radiographic disease progression, unacceptable toxicity, or other protocol-defined discontinuation criteria. |
| Name | Type | Description |
|---|---|---|
| PF-06821497 | DRUG | 875 mg BID (2 times a day) |
| Docetaxel | DRUG | 75 mg/m2 IV (every 21 days) |
| Enzalutamide | DRUG | 160 mg QD |
| Mevrometostat | DRUG | 875 mg oral tablet, taken twice daily with food |
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. * Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan. * Progressive disease in the setting of surgical or medical castration with ...