Actively Recruiting
Randomized Study of Zilovertamab Vedotin Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-Nave GCB DLBCL
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
594
Participants Needed
126
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. This phase 2 study compares the effects of zilovertamab vedotin combined with R-CHP chemotherapy versus polatuzumab vedotin combined with R-CHP in people newly diagnosed with this type of lymphoma. The goal is to see if the cancer responds better to one treatment over the other. Participants will be randomly assigned to receive either zilovertamab vedotin or polatuzumab vedotin, both given by intravenous infusion on the first day of each 3-week cycle for up to six cycles about 4 months. Alongside these drugs, participants will receive cyclophosphamide, doxorubicin, and rituximab or a rituximab biosimilar by IV infusion, plus prednisone or prednisolone orally for five days each cycle. Those with high-risk DLBCL may receive two additional cycles of rituximab or its biosimilar. During the study, participants will have scans and tests to measure cancer response using established criteria over up to 31 months. Researchers will also monitor survival rates, quality of life, and side effects for up to several years. Safety assessments and treatment adherence will be tracked throughout the study and follow-up periods, ensuring thorough evaluation of each treatments impact.
CONDITIONS
Brief Title
A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed germinal center B-cell subtype of diffuse large B-cell lymphoma (DLBCL) by prior biopsy
- PET positive disease at screening defined as 4 to 5 on the Lugano 5-point scale
- No prior treatment for diffuse large B-cell lymphoma
- Well controlled HIV infection on antiretroviral therapy (ART), if applicable
- Hepatitis B surface antigen positive participants must have received antiviral therapy and have undetectable viral load
- History of hepatitis C infection allowed if viral load is undetectable at screening
You will not qualify if you...
- History of transformation of indolent disease to diffuse large B-cell lymphoma
- Diagnosis of primary mediastinal B-cell lymphoma or Grey zone lymphoma
- Ann Arbor Stage I diffuse large B-cell lymphoma
- Active cardiovascular disease such as recent stroke (less than 6 months), myocardial infarction (less than 6 months), unstable angina, congestive heart failure (Class II or higher), or serious cardiac arrhythmia requiring medication
- Clinically significant pericardial or pleural effusion
- Ongoing Grade greater than 1 peripheral neuropathy
- Demyelinating form of Charcot-Marie-Tooth disease
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Ongoing corticosteroid therapy
- Additional malignancy progressing or requiring treatment within past 2 years
- Active central nervous system lymphoma
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active infection requiring systemic therapy
- Active hepatitis B or C infection
- History of stem cell or solid organ transplant
Research Team
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