A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)
A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-004)
Sponsor: Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR) per Lugano Response Criteria
Time frame: Up to approximately 50 months
Secondary Endpoints
Duration of Response (DOR) per Lugano Response Criteria
Number of Participants Who Experience an Adverse Event (AE)
Number of Participants Who Discontinue Study Treatment Due to an AE
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 si…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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