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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06717347 | A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010) | PHASE3 | RECRUITING | 1,046 | — | — | Jan 27, 2025 | Mar 29, 2032 | Jun 8, 2026 | 262 | United States, Argentina +33 |
PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by blinded independent central review (BICR) or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP) | EXPERIMENTAL | Participants receive a dose of zilovertamab vedotin (1.75 mg/kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone, prednisolone, or methylprednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months). |
| Rituximab + Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) | ACTIVE_COMPARATOR | Participants receive 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar, 1.4 mg/m\^2 vincristine administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone, prednisolone, or methylprednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months). |
| Name | Type | Description |
|---|---|---|
| Zilovertamab vedotin | BIOLOGICAL | IV infusion |
| Rituximab | BIOLOGICAL | IV infusion |
| Cyclophosphamide | DRUG | IV infusion |
| Doxorubicin | DRUG | IV infusion |
| Rituximab Biosimilar | BIOLOGICAL | IV infusion |
| Prednisone | DRUG | Per Approved Product Label |
| Prednisolone | DRUG | Oral administration |
| Vincristine | DRUG | IV infusion |
| Rescue medication | DRUG | Participants receive rescue medication per approved product label. The rescue medication is granulocyte colony-stimulating factor (G-CSF). |
| Methylprednisolone | DRUG | Per Approved Product Label |
Inclusion Criteria: * Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues * Has positron emission tomography (PET) positive disease at scre...