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)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Has a history of transformation of indolent disease to DLBCL

Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma

Has Ann Arbor Stage I DLBCL

Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication

Trial design

Treatments tested in this trial

  • Zilovertamab vedotin
  • Rituximab
  • Cyclophosphamide
  • Doxorubicin
  • Rituximab Biosimilar
  • Prednisone
  • Prednisolone
  • Vincristine
  • Rescue medication
  • Methylprednisolone

Treatment groups

1,046 Participants
are divided into 2 treatment groups

Sponsors and collaborators