臨床研究等提出・公開システム

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)

MK-2140 Plus R-CHP Versus R-CHOP for 1L DLBCL

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Recruiting

Feb. 07, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, 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 (ECHO) or multigated acquisition (MUGA).
- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
- 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.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.

- 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.
- Has clinically significant pericardial or pleural effusion.
- Has ongoing Grade >1 peripheral neuropathy.
- Has a demyelinating form of Charcot-Marie-Tooth disease.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has ongoing corticosteroid therapy.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Known active central nervous system (CNS) lymphoma.
- Has active autoimmune disease that has required systemic treatment in the past 2 years.
- Has active infection requiring systemic therapy.
- Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.
- Has history of allogeneic tissue/solid organ transplant.

Both

Diffuse Large B-Cell Lymphoma

[Arm1]MK-2140 in combination with R-CHP will be administered on Day 1 of Cycle 1, and then on Day 1 of each 3-week cycle, for up to 6 cycles. Participants with high-risk DLBCL will be allowed to receive rituximab for an additional 2 cycles. Prednisone will also be administered on Days 2 to 5 of each cycle.
[Arm2]R-CHOP (Arm 2) will be administered on Day 1 of Cycle 1, and then on Day 1 of each 3-week cycle, for up to 6 cycles. Participants with high-risk DLBCL will be allowed to receive rituximab for an additional 2 cycles. Prednisone will also be administered on Days 2 to 5 of each cycle.

progression-free survival

- complete response (CR) rate
- overall survival
- event-free survival
- duration of CR
- safety and tolerability
- health-related quality of life

+81-86-235-7534

Dec. 19, 2024

Yes

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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