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

  • STATUS
    Recruiting
  • End date
    Jun 10, 2025
  • participants needed
    100
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 17 September 2022

Summary

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.

Details
Condition Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Treatment MK-2140 (zilovertamab vedotin)
Clinical Study IdentifierNCT05144841
SponsorMerck Sharp & Dohme LLC
Last Modified on17 September 2022

Eligibility

Yes No Not Sure

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 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
Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent)
must have recovered from all radiation-related toxicities
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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