> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-zilovertamab-vedotin-mk-2140-combination-47c43a74-d190-4960-aac9-afe2cea567bf > Record changed: 2026-10-13 # 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) NCT06717347 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) Participants 1,046 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) Start date 2025-01-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) Number of sites 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Official title** A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) ## Dates **Completion date** 2032-03-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **First posted** 2024-12-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Primary completion date** 2029-07-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Start date** 2025-01-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) ## Size and sites **Participants** 1,046 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Planned participants** 1,046 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Number of sites** 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) ## Identifiers **Registry ID** NCT06717347 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **ClinicalTrials.gov ID** NCT06717347 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) ## Outcomes ### Primary outcomes 1. Progression-free survival (PFS) Timeframe: Up to \~ 50 months 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. ### Secondary outcomes 1. Complete Response at End of Treatment (CR at EOT) Timeframe: Up to \~ 32 months 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. 2. Overall Survival (OS) Timeframe: Up to \~ 74 months OS is defined as the time from randomization to death due to any cause. 3. Event-free Survival (EFS) Timeframe: Up to \~ 74 months 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. 4. Duration of Complete Response (DurCR) Timeframe: Up to \~ 74 months 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. 5. Number of Participants Who Experience an Adverse Event (AE) Timeframe: Up to \~ 9 months An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented. 6. Number of Participants Who Discontinue Study Treatment Due to an AE Timeframe: Up to \~ 6 months An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented. 7. Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI) Score Timeframe: Baseline and Week 25 The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60\. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108\. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116\. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168\. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life. 8. Change From Baseline in HRQoL on FACT-Lym Total Score Timeframe: Baseline and Week 25 The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60\. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108\. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116\. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168\. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life. 9. Change From Baseline in HRQoL on FACT-Lym Physical Wellbeing (PWB) Score Timeframe: Baseline and Week 25 The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60\. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108\. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116\. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168\. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life. 10. Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score Timeframe: Baseline and Week 25 The FACT GOG-NTX provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. It is an 11-item questionnaire designed to measure the neurotoxicity subscale. The scoring of FACT GOG-NTX is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. To produce a Neurotoxicity Subscale score (range 0-44), multiply the sum of the item scores by the number of items in the subscale, then divide by the number of items answered. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) ## Sites - USA Mitchell Cancer Institute ( Site 0173)Mobile, United StatesRecruiting - Banner MD Anderson Cancer Center ( Site 0165)Gilbert, United StatesRecruiting - Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167)Phoenix, United StatesRecruiting - The University of Arizona Cancer Center - North Campus ( Site 0124)Tucson, United StatesRecruiting - Providence Medical Foundation-Oncology ( Site 0168)Fullerton, United StatesRecruiting - MemorialCare Health System - Long Beach Medical Center ( Site 9559)Long Beach, United StatesRecruiting - Cancer Blood and Specialty Clinic ( Site 0109)Los Alamitos, United StatesRecruiting - Cedars-Sinai Medical Center ( Site 0115)Los Angeles, United StatesRecruiting - Pacific Hematology Oncology Associates ( Site 0131)San Francisco, United StatesRecruiting - Lutheran Hospital - Cancer Centers of Colorado ( Site 0180)Golden, United StatesRecruiting - Clermont Oncology Center ( Site 0182)Clermont, United StatesRecruiting - Bioresearch Partner ( Site 0157)Hialeah, United StatesRecruiting - Orlando Health Cancer Institute ( Site 0169)Ocoee, United StatesRecruiting - Mid Florida Hematology and Oncology Center ( Site 0172)Orange City, United StatesRecruiting - University Cancer & Blood Center, LLC ( Site 0141)Athens, United StatesRecruiting - Cancer Care Specialists of Illinois ( Site 0152)O'Fallon, United StatesRecruiting - Fort Wayne Medical Oncology and Hematology ( Site 0149)Fort Wayne, United StatesRecruiting - Cotton O'Neil Cancer Center ( Site 0108)Topeka, United StatesRecruiting - University of Kentucky ( Site 0106)Lexington, United StatesRecruiting - Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0163)Louisville, United StatesRecruiting - Owensboro Medical Health System ( Site 0195)Owensboro, United StatesRecruiting - CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0184)Alexandria, United StatesRecruiting - American Oncology Partners, P.A. ( Site 0185)Bethesda, United StatesRecruiting - Karmanos Cancer Institute ( Site 0174)Detroit, United StatesRecruiting - Corewell Health ( Site 0130)Grand Rapids, United StatesRecruiting And 245 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](https://www.merckclinicaltrials.com/) ### Other registry identifiers (4) - MK-2140-010 - U1111-1309-3971 - jRCT2061240099 - 2024-515566-13-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06717347) ## Related records ### Drugs (9) - [Cetirizine hydrochloride](https://trialight.com/data/asset/cetirizine-hydrochloride-0f5b8ec9-315b-492f-b7a3-de74652b5fd2.md) - [Cirmtuzumab](https://trialight.com/data/asset/cirmtuzumab-2e8f54d4-5214-4698-8544-18a9d77e438c.md) - [Cyclophosphamide](https://trialight.com/data/asset/cyclophosphamide-25b75968-e3cd-410a-9b24-0c349d8f7663.md) - [Doxorubicin hydrochloride](https://trialight.com/data/asset/doxorubicin-hydrochloride-2e3493ba-9766-475e-aa7d-f2debf111de5.md) - [Methylprednisolone](https://trialight.com/data/asset/methylprednisolone-f881999e-4ad3-485a-8fbe-6e7b979365f9.md) - [Prednisolone](https://trialight.com/data/asset/prednisolone-783fce19-b285-4835-90c3-3db5a6364414.md) - [Prednisone](https://trialight.com/data/asset/prednisone-a5a99f90-5fbe-45c2-a625-34ba78735da6.md) - [Rituximab](https://trialight.com/data/asset/rituximab-3fb73477-f618-414e-aa0a-9ccba4d6da3f.md) - [Vincristine](https://trialight.com/data/asset/vincristine-1701ac43-1743-4b51-a2db-509772d24571.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Conditions (2) - [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) Primary condition - [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) ### Targets (20) - [HRH1](https://trialight.com/data/target/hrh1-066d4575-4b1c-5ce9-adf8-b080f76b770b.md) - [MS4A1](https://trialight.com/data/target/ms4a1-9e34d7a7-7b3d-5f02-928a-d18d9b50c1f8.md) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) - [ROR1](https://trialight.com/data/target/ror1-af4a7f63-4559-5599-9f7d-abf429641139.md) - [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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