Trials / Recruiting
RecruitingNCT06717347
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)
A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,046 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Zilovertamab vedotin | IV infusion |
| BIOLOGICAL | Rituximab | IV infusion |
| DRUG | Cyclophosphamide | IV infusion |
| DRUG | Doxorubicin | IV infusion |
| BIOLOGICAL | Rituximab Biosimilar | IV infusion |
| DRUG | Prednisone | Per Approved Product Label |
| DRUG | Prednisolone | Oral administration |
| DRUG | Vincristine | IV infusion |
| DRUG | Rescue medication | Participants receive rescue medication per approved product label. The rescue medication is granulocyte colony-stimulating factor (G-CSF). |
| DRUG | Methylprednisolone | Per Approved Product Label |
Timeline
- Start date
- 2025-01-27
- Primary completion
- 2029-07-02
- Completion
- 2032-03-29
- First posted
- 2024-12-05
- Last updated
- 2026-04-16
Locations
250 sites across 35 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, Romania, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06717347. Inclusion in this directory is not an endorsement.