The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.
Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues
Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale
Has received no prior treatment for their DLBCL
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
Has a history of transformation of indolent disease to DLBCL
Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma
Has Ann Arbor Stage I DLBCL
Has clinically significant (i.e., 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 serious cardiac arrhythmia requiring medication
Parallel
Zilovertamab vedotin
Biological/VaccineIV infusion
Rituximab
Biological/VaccineIV infusion
Cyclophosphamide
DrugIV infusion
Doxorubicin
DrugIV infusion
Rituximab Biosimilar
Biological/VaccineIV infusion
Prednisone
DrugPer Approved Product Label
Prednisolone
DrugOral administration
Vincristine
DrugIV infusion
Rescue medication
DrugParticipants receive rescue medication per approved product label. The rescue medication is granulocyte colony-stimulating factor (G-CSF).
Methylprednisolone
DrugPer Approved Product Label
Progression-free survival (PFS)
PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by blinded independent central review (BICR) or death due to any cause, whichever occurs first.
Complete Response at End of Treatment (CR at EOT)
CR at EOT is defined as a CR per Lugano response criteria as assessed by BICR at end of treatment. Participants with missing data or who discontinue treatment or study prior to reaching EOT will be considered non-responders and included in the total number of participants.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Event-free Survival (EFS)
EFS is defined as the time from randomization to any of the following events: progressive disease that precludes surgery, local or distant recurrence, second primary malignancy or death due to any cause. The EFS for all participants will be presented.
Duration of Complete Response (DurCR)
For participants who demonstrate CR at EOT per Lugano response criteria by BICR, duration of complete response is defined as the time from the first documented evidence of CR at or before EOT until disease progression or death due to any cause, whichever occurs first.
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