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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)

Status
Active
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06717347
Protocol IDs
2140-010 (primary)
NCI-2025-03604
2024-515566-13
2024-515566-13-00
jRCT2061240099
MK-2140-010
U1111-1309-3971
Study Sponsor
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

  1. 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
  2. Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale
  3. Has received no prior treatment for their DLBCL
  4. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
  5. Has an ejection fraction =45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)
  6. Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
  7. Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization
  8. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.