A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)

Completed · Phase 2

Conditions studied: Relapsed or Refractory Diffuse Large B-Cell Lymphoma

In brief

The purpose of this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study.

Key facts

Study ID

NCT05144841

Run by

Merck Sharp & Dohme LLC

People needed

140

Starts

2022-01-08

Expected to finish

2026-04-21

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has relapsed or refractory (rr) DLBCL; has progressed after at least 2 lines of prior therapy; and has progressed after auto- stem cell transplant (SCT) or are auto-SCT ineligible. Must have received prior multiagent regimen that includes an alkylating agent. anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody.
• Has histologically confirmed diagnosis of DLBCL.
• Has radiographically measurable DLBCL per the Lugano Response Criteria.
• Should either be post- chimeric antigen receptor T cell therapy (CAR-T) failure or ineligible for CAR-T (for any reason).
• Life expectancy of at least 3 months.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before time of enrollment.
• Has adequate organ function.

You may not qualify if…

• Has received a diagnosis of Primary mediastinal B-cell lymphoma (PMBCL).
• Has undergone solid organ transplant at any time.
• Has a history of any clinically significant cardiovascular conditions within 6 months of screening or serious cardiac arrhythmia requiring medication.
• Has known history of liver cirrhosis.
• Has pericardial effusion or clinically significant pleural effusion.
• Has ongoing Grade >1 peripheral neuropathy.
• Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
• Transformed DLBCL from indolent lymphoma.
• In participants with prior allo-SCT, acute graft versus host disease (GVHD) or ongoing evidence of chronic GVHD.
• Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
• Has received prior radiotherapy within 28 days of start of study intervention. Participants.
• must have recovered from all radiation-related toxicities.
• Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent).
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
• Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma.
• Has an active infection requiring systemic therapy.
• Has a known history of human immunodeficiency virus (HIV) infection.
• Has a known history of hepatitis B or known active hepatitis C virus (HCV).

Where it is running

• Innovative Clinical Research Institute ( Site 0202) — Whittier, California, United States
• Georgetown University Medical Center ( Site 0204) — Washington D.C., District of Columbia, United States
• Northside Hospital ( Site 0206) — Atlanta, Georgia, United States
• University of Chicago Medical Center ( Site 0207) — Chicago, Illinois, United States
• Franciscan St. Francis Health ( Site 0225) — Indianapolis, Indiana, United States
• University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0211) — Baltimore, Maryland, United States
• Massachusetts General Hospital-Cancer Center Protocol Office ( Site 0203) — Boston, Massachusetts, United States
• University of Michigan ( Site 0200) — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute ( Site 0216) — Detroit, Michigan, United States
• Saint Louis University Cancer Center ( Site 0209) — St Louis, Missouri, United States
• Atlantic Health System Morristown Medical Center ( Site 0213) — Morristown, New Jersey, United States
• New York Medical College ( Site 0215) — Valhalla, New York, United States
• University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0217) — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center ( Site 0222) — Cleveland, Ohio, United States
• The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C — Columbus, Ohio, United States
• AHN West Penn Hospital ( Site 0212) — Pittsburgh, Pennsylvania, United States
• Avera Cancer Institute- Research ( Site 0233) — Sioux Falls, South Dakota, United States
• MEDICAL COLLEGE OF WISCONSIN ( Site 0234) — Milwaukee, Wisconsin, United States
• Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0100) — Toronto, Ontario, Canada
• James Lind Centro de Investigación del Cáncer ( Site 2705) — Temuco, Araucania, Chile
• Clínica Alemana de Santiago ( Site 2704) — Santiago, Region M. de Santiago, Chile
• Beijing Cancer hospital ( Site 2900) — Beijing, Beijing Municipality, China
• SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 2907) — Guangzhou, Guangdong, China
• Henan Cancer Hospital-hematology department ( Site 2903) — Zhengzhou, Henan, China
• St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0229) — Orange, California, United States

Full record on ClinicalTrials.gov

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