Merck,MK2140-010,Ph 3,Randomized, Lymphoma, Zilovertamab vedotin + R-CHP vs R-Chop

What is the Purpose of this Study?

Primary Objective: To compare zilovertamab vedotin plus R-CHP with R-CHOP with respect to progression-free survival (PFS) per Lugano response criteria as assessed by blinded independent central review (BICR). Hypothesis (H1): Zilovertamab vedotin plus R-CHP is superior to R-CHOP with respect to PFS per Lugano response criteria as assessed by BICR. To compare zilovertamab vedotin plus R-CHP with R-CHOP with respect to complete response (CR) rate at end of treatment (EoT) per Lugano response criteria as assessed by BICR. Hypothesis (H2): Zilovertamab vedotin plus R-CHP is superior to R-CHOP with respect to confirmed CR rate at EoT per Lugano response criteria as assessed by BICR. Secondary Objectives: To compare zilovertamab vedotin plus R-CHP with R-CHOP with respect to overall survival (OS). Hypothesis (H3): Zilovertamab vedotin plus R-CHP is superior to R-CHOP with respect to OS. To evaluate event-free survival (EFS) with zilovertamab vedotin plus R-CHP versus R-CHOP per Lugano response criteria as assessed by BICR. To evaluate the duration of CR of zilovertamab vedotin plus R-CHP versus R-CHOP. To evaluate the safety and tolerability of zilovertamab vedotin plus R-CHP. To evaluate changes from baseline in health-related QoL assessments using the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and FACT/GOG-NTX. To evaluate time to deterioration (TTD) in health-related QoL assessments using the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and FACT/GOG-NTX.


Eligibility

  • * 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
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Where can I participate?

  • CS Cancer at Beverly Hills
  • CS Cancer at Cedars-Sinai Medical Center


More about this Clinical Trial

What is the full name of this clinical trial?

MK2140-010: A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma

Study Details
Disease Type/Condition

Other Hematopoietic

Principal Investigator

Darrah, Justin

Co-Investigators

Akil Merchant, Barry Rosenbloom, David Hoffman, Jeremy Lorber, Joshua Sasine, Kevin Scher, Sepehr Rokhsar

Age Group

Adult

Phase

III

IRB Number

STUDY00003859

ClinicalTrials.gov ID

NCT06717347

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other Hematopoietic

Principal Investigator

Darrah, Justin

Age Group

Adult

Phase

III

IRB Number

MK2140-010

ClinicalTrials.gov ID

NCT06717347

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org