Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zilovertamab vedotin Infusion-kg · 1 trial · 1 indication
Rate of complete response to up to 6 cycles of combination zilovertamab vedotin and lenalidomide as determined by first documented disease progression per Lugano response criteria.
| Arm | Type | Description |
|---|---|---|
| Zilovertamab vedotin (1.75mg/kg) Q3W + Lenalidomide (15mg p.o. 14 days) | EXPERIMENTAL | Induction phase: Zilovertamab vedotin (1.75mg/kg) will be administered using a 30-minute IV infusion on Day 1 of Cycle 1, and then on Day 1 of each 3-week (21-day) cycle, for up to 6 cycles. Capsules of lenalidomide (15mg) will be administered orally (p.o) on planned dosing days (14 days per cycle) for up to 6 cycles. Participants will have FDG PET/CT scans at the start of the study, prior to induction treatment and following cycle 2 and 6. Response assessments will be undertaken according to Lugano criteria. Participants achieving an objective response will continue onto maintenance phase. Maintenance phase: Lenalidomide treatment (15mg p.o, 14 days of a 21 day cycle) for up to 6 additional cycles. After finishing treatment, participants will attend follow-up visits every 3 months for up to 24 months. |
| Name | Type | Description |
|---|---|---|
| Zilovertamab vedotin Intravenous (IV) Infusion - 1.75 mg/kg | BIOLOGICAL | Zilovertamab vedotin Intravenous (IV) Infusion - 1.75 mg/kg will be administered every 3 weeks for 6 cycles |
| Lenalidomide | DRUG | Lenalidomide (15mg) will be administered by mouth for 14 days of each 21 day cycle. 6 cycles will be administered in combination with zilovertamab vedotin, in participants with an objective response, a further 6 cycles will be administered (maximum of 12 cycles) |
Inclusion Criteria: 1. Histologically confirmed R/R nodal PTCL which include subtypes T-follicular helper cell lymphoma (angioimmunoblastic T-cell lymphoma, follicular T-helper cell lymphoma, T-follicular helper cell lymphoma-not otherwise specified), anaplastic large cell lymphoma (ALCL; both ALK+...
Zilovertamab vedotin infusion-kg is being studied for relapsed or refractory peripheral T-cell lymphoma, a type of lymphoma that has returned or stopped responding to prior treatment. It is an antibody-drug conjugate in Phase 2 development and is not yet approved for this use.
Zilovertamab vedotin is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is running the clinical program evaluating the antibody-drug conjugate in relapsed or refractory peripheral T-cell lymphoma.
Zilovertamab vedotin is in Phase 2 clinical development. It is investigational and is being evaluated in a single Phase 2 study in relapsed or refractory peripheral T-cell lymphoma. The program has one active trial and no completed trials.
Zilovertamab vedotin is being studied in NCT07913594, a Phase 2 trial titled Zilovertamab Vedotin and Lenalidomide (ZiVLen) Therapy for Relapsed/Refractory Peripheral T-Cell Lymphoma. The trial plans to enroll 25 participants aged 18 years and older in Australia and is not yet recruiting.
Yes. Zilovertamab vedotin infusion-kg and zilovertamab vedotin intravenous (IV) infusion at 1.75 mg/kg refer to the same antibody-drug conjugate given by IV infusion at a weight-based dose. Both names describe the Merck-developed therapy under study in peripheral T-cell lymphoma.
NCT07913594 is an open-label, uncontrolled Phase 2 study combining zilovertamab vedotin with lenalidomide in relapsed or refractory peripheral T-cell lymphoma. It is not randomized or double-blinded, enrolls 25 participants, includes both sexes, and does not accept healthy volunteers.