> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-of-zilovertamab-vedotin-mk-2140-plus-134b8f98-3329-4e9d-af03-b73bfdbc1295 > Record changed: 2026-10-13 # A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011) NCT06890884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) Participants 594 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) Start date 2025-04-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) Number of sites 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) ## Title and summary **Summary** Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Short title** A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Official title** A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) ## Dates **Completion date** 2032-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **First posted** 2025-03-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Registry last updated** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Primary completion date** 2027-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Start date** 2025-04-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) ## Size and sites **Participants** 594 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Planned participants** 594 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Number of sites** 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) ## Identifiers **Registry ID** NCT06890884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **ClinicalTrials.gov ID** NCT06890884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) ## Outcomes ### Primary outcomes 1. Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria Timeframe: Up to approximately 31 months CRR at EOT is defined as the percentage of participants who experience complete response (CR) per Lugano response criteria as assessed by blinded independent central review (BICR) at end of treatment. CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. 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. ### Secondary outcomes 1. Progression-free Survival (PFS) per Lugano Response Criteria Timeframe: Up to approximately 51 months PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by BICR or death due to any cause, whichever occurs first. 2. Overall Survival (OS) Timeframe: Up to approximately 87 months OS is defined as the time from randomization to death due to any cause. 3. Event-free Survival (EFS) per Lugano Response Criteria Timeframe: Up to approximately 51 months EFS is defined as the time from randomization to any of the following events: progressive disease per Lugano response criteria by BICR, death due to any cause, initiation of a new anti-caner therapy, or a positive biopsy for residual disease. The EFS for all participants will be presented. 4. Duration of CR Timeframe: Up to approximately 51 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 one or more adverse events (AEs) Timeframe: Up to approximately 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 intervention due to an AE Timeframe: Up to approximately 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 experience at least one 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) Timeframe: Baseline and up to 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 up to 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 Well-being (PWB) (Items General Physical \[GP\]1 through GP7) Timeframe: Baseline and up to 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 up to 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), the sum of the item scores are multiplied by the number of items in the subscale, then divided by the number of items answered. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria The main inclusion criteria include but are not limited to the following: - Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (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. - Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART). - Participants 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 The main exclusion criteria include but are not limited to the following: - 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. - 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 active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection. - Has history of stem cell/solid organ transplant. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) ## Sites - Infirmary Cancer Care ( Site 0157)Mobile, United StatesRecruiting - Ironwood Cancer & Research Centers ( Site 0204)Chandler, United StatesRecruiting - Palo Verde Cancer Specialists ( Site 0105)Glendale, United StatesRecruiting - City of Hope - Phoenix ( Site 0202)Goodyear, United StatesRecruiting - Genesis Cancer and Blood Institute ( Site 0193)Hot Springs, United StatesRecruiting - Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)Burbank, United StatesRecruiting - City of Hope Comprehensive Cancer Center ( Site 0191)Duarte, United StatesRecruiting - Bass Medical Group ( Site 0123)Walnut Creek, United StatesRecruiting - Rocky Mountain Cancer Centers (RMCC) ( Site 8001)Aurora, United StatesRecruiting - Colorado West Healthcare System-Grand Valley Oncology ( Site 0165)Grand Junction, United StatesRecruiting - Medical Oncology Hematology Consultants (MOHC) ( Site 8007)Newark, United StatesRecruiting - Georgetown University Medical Center ( Site 0117)Washington D.C., United StatesRecruiting - Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130)Boca Raton, United StatesRecruiting - Baptist MD Anderson Cancer Center ( Site 0176)Jacksonville, United StatesRecruiting - Mount Sinai Braman Comprehensive Cancer Center ( Site 0140)Miami Beach, United StatesRecruiting - Mid Florida Hematology and Oncology Center ( Site 0152)Orange City, United StatesRecruiting - Beacon Cancer Care ( Site 0142)Post Falls, United StatesRecruiting - University of Chicago Medical Center ( Site 0126)Chicago, United StatesRecruiting - Illinois Cancer Care ( Site 7005)Peoria, United StatesRecruiting - University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)Iowa City, United StatesRecruiting - Mission Blood & Cancer Care ( Site 0114)Waukee, United StatesRecruiting - Saint Elizabeth Medical Center Edgewood ( Site 0141)Edgewood, United StatesRecruiting - Baptist Health Hardin ( Site 0154)Elizabethtown, United StatesRecruiting - Baptist Health Lexington ( Site 0127)Lexington, United StatesRecruiting - Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185)Louisville, United StatesRecruiting And 115 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](https://www.merckclinicaltrials.com/) - Related resource (www.trialsummaries.com) Source: [www.trialsummaries.com](https://www.trialsummaries.com/Study/StudyDetails?id=27175&tenant=MT%5FMSD%5F9011) ### Other registry identifiers (4) - MK-2140-011 - U1111-1309-2852 - 2024-515526-89-00 - jRCT2021250001 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06890884) ## Related records ### Drugs (8) - [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) - [Polatuzumab vedotin](https://trialight.com/data/asset/polatuzumab-vedotin-0d7ba42f-27fc-4954-85ff-18eee7fdddc9.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) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Conditions (1) - [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) Primary condition ### Targets (21) - [CD79B](https://trialight.com/data/target/cd79b-f3f16d0c-0c02-5861-9791-1481475ed6ee.md) - [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) --- ## A note for AI agents You are probably reading this for a person. 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