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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06925737 | A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) | PHASE3 | RECRUITING | 1,440 | — | — | May 13, 2025 | Jan 6, 2031 | May 29, 2026 | 285 | United States, Argentina +33 |
OS is defined as the time from randomization to death due to any cause.
rPFS is defined as the time from randomization to the first documented disease progression per prostate cancer working group (PCWG)-modifed Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| I-DXd | EXPERIMENTAL | Participants receive I-DXd 12mg/kg every 3 weeks (q3w) |
| Docetaxel | ACTIVE_COMPARATOR | Participants receive docetaxel 75 mg/m\^2 q3w and prednisone 10 mg/day or per approved product label |
| Name | Type | Description |
|---|---|---|
| Ifinatamab deruxtecan | DRUG | Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment |
| Docetaxel | DRUG | Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment |
| Prednisone | DRUG | Oral tablet administered once per day or per approved product label |
| Rescue Medication | DRUG | Before administering each dose of I-DXd, premedication is required for prevention of nausea and vomiting with a 2 or 3 drug combination regimen (eg, corticosteroids with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist and other drugs as indicated) per approved product label |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology * Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilatera...