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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06132958 | Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005) | PHASE3 | ACTIVE NOT_RECRUITING | 710 | — | — | Dec 6, 2023 | Jan 10, 2028 | Apr 3, 2026 | 241 | United States, Argentina +29 |
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
OS is defined as the time from randomization to death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Sacituzumab tirumotecan | EXPERIMENTAL | Participants will receive 4 mg/kg of sacituzumab tirumotecan via intravenous (IV) infusion on Day 1 of each 14-day cycle. |
| Chemotherapy | ACTIVE_COMPARATOR | Participants will receive 60 mg/m\^2 of doxorubicin by IV infusion on Day 1 of each 21-day cycle; or 80 mg/m\^2 of paclitaxel by IV infusion on Days 1, 8, and 15 of each 28-day cycle. Participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive Nab-paclitaxel. |
| Name | Type | Description |
|---|---|---|
| Sacituzumab tirumotecan | BIOLOGICAL | 4 mg/kg of sacituzumab tirumotecan by IV infusion |
| Doxorubicin | DRUG | 60 mg/m\^2 of doxorubicin by IV Infusion |
| Paclitaxel | DRUG | 80 mg/m\^2 of paclitaxel by IV infusion |
| Nab-paclitaxel | DRUG | 100 mg/m\^2 of nab-paclitaxel by IV infusion |
| Rescue medications | DRUG | Participants will receive the following rescue medications per approved product label before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent). |
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma. * Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation cr...