A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)
A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP in Participants With DLBCL (waveLINE)
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)
Number of Participants Who Experienced Dose-limiting Toxicities (DLTs) in Cycle 1
Time frame: Cycle 1 (up to 21 days)
Number of Participants Who Experienced At Least One AE
Time frame: Up to approximately 8 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Time frame: Up to approximately 5.5 months
Complete Response Rate (CRR) per Lugano Response Criteria
Time frame: Up to approximately 60 months
Secondary Endpoints
Objective Response Rate (ORR) per Lugano Response Criteria
Duration of Response (DOR) per Lugano Response Criteria
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion: * Has histologically confirmed diagnosis of DLBCL by prior biopsy * Has PET-positive disease verified by blinded independent central review (BICR) at screening, defined as 4-5 on the Lugano response criteria 5-point scale * Has received no prior treatment for DLBCL * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days prior to the start of study intervention Exclusion: * Has a history of transformation of indolent disease to DLBCL * Has received solid organ transplant at any time * Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) * Has clinically significant (ie, 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…
Read full criteria on CT.gov →✦ Analyst Commentary
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