NCT06717347 A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)
| NCT ID | NCT06717347 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Diffuse Large B-Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,046 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2029-07-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,046 participants in total. It began in 2025-01-27 with a primary completion date of 2029-07-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA) * Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART) * Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening Exclusion Criteria: * 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 * Has clinically significant pericardial or pleural effusion * Has ongoing Grade \>1 peripheral neuropathy * Has a demyelinating form of Charcot-Marie-Tooth disease * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has ongoing corticosteroid therapy * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed * Known additional malignancy that is progressing or has required active treatment within the past 2 years * Known active central nervous system (CNS) lymphoma * Has active autoimmune disease that has required systemic treatment in the past 2 years * Has active infection requiring systemic therapy * Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection * Has history of allogeneic tissue/solid organ transplant
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT06717347 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diffuse Large B-Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06717347 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,046 participants.
Is NCT06717347 currently recruiting?
Yes, NCT06717347 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT06717347 trial being conducted?
This trial is being conducted at Mobile, United States, Gilbert, United States, Phoenix, United States, Tucson, United States and 11 additional locations.
Who is sponsoring the NCT06717347 clinical trial?
NCT06717347 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 1,046 participants.