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)

Merck Sharp & Dohme LLC

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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 screening, defined as 4 to 5 on the Lugano 5-point scale * Has received no prior treatment for their DLBCL * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization * Has an ejection fraction ≥45% as determined by either echocardiogram (E…

Interventions

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

Locations (253)

Banner MD Anderson Cancer Center ( Site 0165)
Gilbert, Arizona
480-256-6444
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167)
Phoenix, Arizona
480-256-6444
The University of Arizona Cancer Center - North Campus ( Site 0124)
Tucson, Arizona
520-621-5497
Providence Medical Foundation-Oncology ( Site 0168)
Fullerton, California
714-446-5900
Cancer Blood and Specialty Clinic ( Site 0109)
Los Alamitos, California
562-200-0203
Cedars-Sinai Medical Center ( Site 0115)
Los Angeles, California
310-423-3277