A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017 | Recruiting Phase 2 DMC FDA Drug

• 7 other identifiers: 2140-003VLS-101MK-2140-003waveLINE-0032022-502646-27-00U1111-1285-0898jRCT2011250068
• Study Type: interventional
• Target: 290
• Locations: 24 countries
• Sites: 120

Brief Summary

The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR. With protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab \[BR\] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.

Conditions

DLBCL; Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (5)

• Number of participants who experienced dose-limiting toxicities (DLTs) in Part 1

  The CTCAE, Version 5.0 will be used to grade the severity of AEs in this study. DLTs will be reported for Part 1 of this study.

  Up to ~6 weeks

• Number of participants who experienced an adverse event (AE)

  An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experienced an AE will be reported.

  Up to ~68 months

• Number of participants who discontinued study treatment due to an AE

  An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinued study treatment due to an AE will be reported.

  Up to ~68 months

• Overall survival (OS)

  OS, defined as the time from randomization to death due to any cause will be reported.

  Up to ~35 months

• Progression-free survival (PFS)

  PFS, defined as the time from randomization to the first documented disease progression per Lugano response criteria as assessed by BICR or death due to any cause, whichever occurs first will be presented.

  Up to ~35 months

Secondary Outcomes (2)

• Objective response rate (ORR)

  Up to ~35 months

• Duration of response (DOR)

  Up to ~35 months

Study Arms (6)

ZV + R-GemOx (Part 1)

EXPERIMENTAL

Participants in this arm will receive doses of ZV (from 1.5 mg/Kg up to 2.5 mg/Kg) plus Rituximab 375 mg/m\^2, Gemcitabine 1000 mg/m\^2 and Oxaliplatin 100 mg/m\^2 (R-GemOx) given intravenously on Day 1 of repeated 21-day cycles. Treatment will continue for up to 6 cycles.

Biological: Zilovertamab vedotin; Biological: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Granulocyte Colony-Stimulating Factor (G-CSF)

ZV + R-GemOx (Part 2)

EXPERIMENTAL

Using the recommended Phase 2 dose (RP2D) dose of ZV plus R-GemOx from Part 1, participants will receive ZV plus R-GemOx given intravenously on Day 1 of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.

Biological: Zilovertamab vedotin; Biological: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Granulocyte Colony-Stimulating Factor (G-CSF)

R-GemOx (active control for Part 2)

ACTIVE COMPARATOR

Participants will receive R-GemOx given intravenously on Day 1 of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.

Biological: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin

ZV + BR (Part 2)

EXPERIMENTAL

Using RP2D from Part 1, participants will receive ZV plus Rituximab 375 mg/m\^2, given intravenously on Day 1 and Bendamustine 90 mg/m\^2 given intravenously on Day 1 and 2, of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.

Biological: Zilovertamab vedotin; Biological: Rituximab; Drug: Bendamustine; Drug: Granulocyte Colony-Stimulating Factor (G-CSF)

Bendamustine Rituximab (BR)

ACTIVE COMPARATOR

Participants will receive Rituximab 375 mg/m\^2, given intravenously on Day 1 Bendamustine 90 mg/m\^2 given intravenously on Day 1 and 2 of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.

Biological: Rituximab; Drug: Bendamustine

ZV + BR (Part 1)

EXPERIMENTAL

Participants in this arm will receive doses of ZV (from 1.5 mg/Kg up to 2.5 mg/Kg) plus Rituximab 375 mg/m\^2, Bendamustine 90 mg/m\^2 (BR) given intravenously on Day 1 and 2 of repeated 21-day cycles. Treatment will continue for up to 6 cycles.

Biological: Zilovertamab vedotin; Biological: Rituximab; Drug: Bendamustine; Drug: Granulocyte Colony-Stimulating Factor (G-CSF)

Interventions

Zilovertamab vedotin BIOLOGICAL

Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg

Also known as: MK-2140, VLS-101

ZV + BR (Part 1); ZV + BR (Part 2); ZV + R-GemOx (Part 1); ZV + R-GemOx (Part 2)

Gemcitabine DRUG

IV Infusion 1000 mg/m\^2

Also known as: Gemzar®

R-GemOx (active control for Part 2); ZV + R-GemOx (Part 1); ZV + R-GemOx (Part 2)

Oxaliplatin DRUG

IV Infusion 100 mg/m\^2

Also known as: Eloxatin®

R-GemOx (active control for Part 2); ZV + R-GemOx (Part 1); ZV + R-GemOx (Part 2)

Bendamustine DRUG

IV Infusion 90 mg/m\^2

Also known as: Bendeka®, Treanda®, Belrapzo®

Bendamustine Rituximab (BR); ZV + BR (Part 1); ZV + BR (Part 2)

Rituximab BIOLOGICAL

IV Infusion 375 mg/m\^2

Also known as: Rituxan®/mabthera, Truxima® (rituximab-abbs), RUXIENCE®, RIABNI®

Bendamustine Rituximab (BR); R-GemOx (active control for Part 2); ZV + BR (Part 1); ZV + BR (Part 2); ZV + R-GemOx (Part 1); ZV + R-GemOx (Part 2)

Granulocyte Colony-Stimulating Factor (G-CSF) DRUG

Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.

ZV + BR (Part 1); ZV + BR (Part 2); ZV + R-GemOx (Part 1); ZV + R-GemOx (Part 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).
• Has radiographically measurable DLBCL per the Lugano Response Criteria, as assessed locally by the investigator.
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment initiation.
• Has adequate organ function.
• Is able to provide new or archival tumor tissue sample not previously irradiated.
• Zilovertamab vedotin plus R-GemOx, or R-GemOx study arms:
• Has relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least 1 line of prior therapy.
• Has post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or is ineligible for CAR-T cell therapy.
• Not applicable with protocol amendment 4: Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms:
• Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least 2 lines of prior therapy.
• Has post-CAR-T therapy failure or is ineligible for CAR-T cell therapy.

You may not qualify if:

• Not applicable with protocol amendment 4: Has history of transformation of indolent disease to DLBCL
• Has received solid organ transplant at any time.
• Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL).
• Has clinically significant (ie, active) cardiovascular disease or serious cardiac arrhythmia requiring medication.
• Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD.
• Has clinically significant pericardial or pleural effusion.
• Has ongoing Grade \>1 peripheral neuropathy.
• Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
• Has a demyelinating form of Charcot-Marie-Tooth disease.
• Has contraindication to any of the study intervention components including but not limited to prior anaphylactic reaction.
• Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
• Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
• Has ongoing corticosteroid therapy.
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (122)

Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175)

Glendale, Arizona, 85304, United States

RECRUITING

Beverly Hills Cancer Center ( Site 0184)

Beverly Hills, California, 90211, United States

RECRUITING

Bass Medical Group ( Site 0166)

Walnut Creek, California, 94598, United States

RECRUITING

Innovative Clinical Research Institute ( Site 0122)

Whittier, California, 90603, United States

COMPLETED

Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163)

Boca Raton, Florida, 33486, United States

RECRUITING

Clermont Oncology Center ( Site 0174)

Clermont, Florida, 34711, United States

RECRUITING

BRP-Hialeah Hospital ( Site 0182)

Hialeah, Florida, 33013, United States

RECRUITING

Saint Elizabeth Medical Center Edgewood ( Site 0165)

Edgewood, Kentucky, 41017, United States

RECRUITING

University of Kentucky Chandler Medical Center ( Site 0158)

Lexington, Kentucky, 40536, United States

RECRUITING

Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133)

Louisville, Kentucky, 40207, United States

RECRUITING

University of Maryland ( Site 0123)

Baltimore, Maryland, 21201, United States

RECRUITING

Dana-Farber Cancer Institute-Lymphoma ( Site 0111)

Boston, Massachusetts, 02215, United States

RECRUITING

University of Massachusetts Medical School ( Site 0119)

Worcester, Massachusetts, 01655, United States

RECRUITING

Corewell Health ( Site 0162)

Grand Rapids, Michigan, 49503, United States

RECRUITING

St. Vincent Frontier Cancer Center-Research ( Site 0108)

Billings, Montana, 59102, United States

RECRUITING

Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0188)

Grand Island, Nebraska, 68803, United States

RECRUITING

Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0177)

Omaha, Nebraska, 68130, United States

RECRUITING

Comprehensive Cancer Centers of Nevada ( Site 0168)

Las Vegas, Nevada, 89169, United States

RECRUITING

Atlantic Health System ( Site 0116)

Morristown, New Jersey, 07960, United States

COMPLETED

Presbyterian Rust Jorgensen Cancer ( Site 9506)

Rio Rancho, New Mexico, 87124, United States

RECRUITING

New York Medical College ( Site 0113)

Valhalla, New York, 10595, United States

RECRUITING

Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0156)

Nashville, Tennessee, 37232, United States

COMPLETED

Blue Ridge Cancer Care ( Site 0169)

Roanoke, Virginia, 24014, United States

RECRUITING

Hospital Italiano de Buenos Aires ( Site 2203)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 2205)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Hospital Aleman ( Site 2200)

Buenos Aites, Buenos Aires F.D., C1118AAT, Argentina

RECRUITING

Hospital Privado Universitario de Córdoba ( Site 2202)

Córdoba, Córdoba Province, X5016KEH, Argentina

RECRUITING

Instituto Alexander Fleming ( Site 2201)

CABA, C1426ANZ, Argentina

RECRUITING

Townsville University Hospital ( Site 1800)

Douglas, Queensland, 4814, Australia

RECRUITING

Grampians Health ( Site 1802)

Ballarat, Victoria, 3350, Australia

RECRUITING

Royal Perth Hospital-Haematology ( Site 1801)

Perth, Western Australia, 6000, Australia

RECRUITING

Hospital Erasto Gaertner ( Site 2302)

Curitiba, Paraná, 81520-060, Brazil

RECRUITING

Liga Norte Riograndense Contra o Câncer ( Site 2305)

Natal, Rio Grande do Norte, 59062-000, Brazil

RECRUITING

Hospital Paulistano ( Site 2300)

São Paulo, 01321-001, Brazil

RECRUITING

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)

Toronto, Ontario, M5G 2M9, Canada

COMPLETED

Biocenter ( Site 2401)

Concepción, Biobio, 4070196, Chile

RECRUITING

IC La Serena Research ( Site 2405)

La Serena, Coquimbo Region, 1720430, Chile

RECRUITING

Oncocentro Valdivia ( Site 2407)

Valdivia, Los Ríos Region, 5112129, Chile

RECRUITING

FALP-UIDO ( Site 2400)

Santiago, Region M. de Santiago, 7500921, Chile

COMPLETED

Clínica Inmunocel ( Site 2404)

Santiago, Region M. de Santiago, 7580206, Chile

RECRUITING

Clínica RedSalud Vitacura ( Site 2409)

Santiago, Region M. de Santiago, 7650018, Chile

RECRUITING

Bradfordhill ( Site 2403)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

Beijing Cancer hospital ( Site 3000)

Beijing, Beijing Municipality, 100142, China

RECRUITING

Chongqing University Cancer Hospital-Medical Oncology ( Site 3025)

Chongqing, Chongqing Municipality, 400030, China

ACTIVE NOT RECRUITING

Chongqing University Three Gorges Hospital ( Site 3026)

Chongqing, Chongqing Municipality, 404199, China

ACTIVE NOT RECRUITING

Sun Yat-sen University Cancer Center-Internal Medicine ( Site 3001)

Guangzhou, Guangdong, 510060, China

RECRUITING

Zhujiang Hospital ( Site 3002)

Guangzhou, Guangdong, 510280, China

RECRUITING

The First Affiliated Hospital of Henan University of Science &Technology ( Site 3029)

Luoyang, Henan, 471003, China

ACTIVE NOT RECRUITING

Henan Cancer Hospital-hematology department ( Site 3013)

Zhengzhou, Henan, 450008, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3017)

Wuhan, Hubei, 430048, China

RECRUITING

The First Affiliated Hospital of Nanchang University ( Site 3004)

Nanchang, Jiangxi, 330006, China

ACTIVE NOT RECRUITING

Jiangxi Provincial Cancer Hospital ( Site 3005)

Nanchang, Jiangxi, 330029, China

RECRUITING

The First Hospital of Jilin University-Hematology ( Site 3012)

Changchun, Jilin, 130021, China

RECRUITING

Fudan University Shanghai Cancer Center ( Site 3009)

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

West China Hospital of Sichuan University-Head and Neck Oncology ( Site 3016)

Chengdu, Sichuan, 610041, China

RECRUITING

Sichuan Cancer hospital-Oncology ( Site 3021)

Chengdu, Sichuan, 610042, China

RECRUITING

Zhejiang Cancer Hospital ( Site 3014)

Hangzhou, Zhejiang, 310000, China

RECRUITING

The First Affiliated Hospital Zhejiang University School of Medicine ( Site 3027)

Hangzhou, Zhejiang, 310003, China

RECRUITING

Hospital Pablo Tobon Uribe ( Site 0804)

Medellín, Antioquia, 50034, Colombia

RECRUITING

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)

Bogotá, Bogota D.C., 110131, Colombia

RECRUITING

Instituto Médico de Alta Tecnologia S.A.S ( Site 0803)

Montería, Departamento de Córdoba, 230002, Colombia

RECRUITING

Oncologos del Occidente ( Site 0800)

Pereira, Risaralda Department, 660001, Colombia

RECRUITING

Fundacion Valle del Lili ( Site 0802)

Cali, Valle del Cauca Department, 760032, Colombia

RECRUITING

Hospital Metropolitano - Sede Lindora ( Site 2500)

Santa Ana, Provincia de San José, 10903, Costa Rica

RECRUITING

CIMCA ( Site 2501)

San José, 10103, Costa Rica

RECRUITING

centre hospitalier lyon sud-Service Hématologie ( Site 0702)

Pierre-Bénite, Rhone, 69310, France

COMPLETED

Pitie Salpetriere University Hospital-Clinical haematology ( Site 0700)

Paris, 75013, France

RECRUITING

Evangelismos General Hospital of Athens ( Site 0900)

Athens, Attica, 106 76, Greece

RECRUITING

Regional General Hospital of Athens "Laiko" ( Site 0901)

Athens, Attica, 115 26, Greece

RECRUITING

University Hospital of Alexandroupolis ( Site 0903)

Alexandroupoli, East Macedonia and Thrace, 681 00, Greece

RECRUITING

MEDI-K ( Site 2602)

Guatemala City, 01009, Guatemala

RECRUITING

Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 2601)

Guatemala City, 01010, Guatemala

RECRUITING

CELAN,S.A ( Site 2603)

Guatemala City, 1010, Guatemala

RECRUITING

Queen Mary Hospital ( Site 3100)

Hong Kong, 000000, Hong Kong

RECRUITING

Princess Margaret Hospital ( Site 3101)

Hong Kong, Hong Kong

ACTIVE NOT RECRUITING

Emek Medical Center-Hematology Unit ( Site 1102)

Afula, 1834111, Israel

COMPLETED

Carmel Hospital ( Site 1103)

Haifa, 3436212, Israel

COMPLETED

Hadassah Medical Center ( Site 1100)

Jerusalem, 9112001, Israel

COMPLETED

Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1203)

Rozzano, Milano, 20089, Italy

RECRUITING

IRCCS - AOU di Bologna-Istituto di Ematologia "L. e A. Seragnoli" ( Site 1200)

Bologna, 40138, Italy

COMPLETED

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1202)

Naples, 80131, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 1204)

Roma, 00168, Italy

COMPLETED

Hokkaido University Hospital ( Site 3202)

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center ( Site 3204)

Fukuoka, 811-1395, Japan

RECRUITING

Fukushima Medical University Hospital ( Site 3207)

Fukushima, 960-1295, Japan

RECRUITING

Yamagata University Hospital ( Site 3206)

Yamagata, 990-9585, Japan

RECRUITING

Health Pharma Professional Research S.A. de C.V: ( Site 2700)

Mexico City, Mexico City, 03100, Mexico

COMPLETED

Medivest Centro de Investigación Integral ( Site 2704)

Chihuahua City, 31203, Mexico

COMPLETED

Centro de Infusion Superare ( Site 2701)

Mexico City, 03104, Mexico

COMPLETED

Aotearoa Clinical Trials ( Site 0501)

Auckland, 2025, New Zealand

RECRUITING

Clínicas AUNA Sede Chiclayo ( Site 2803)

Chiclayo, Lambayeque, 14001, Peru

RECRUITING

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 2800)

Surquillo, Muni Metro de Lima, 15038, Peru

RECRUITING

Clínica San Felipe ( Site 2805)

Lima, 15072, Peru

RECRUITING

Hospital Nacional Edgardo Rebagliati Martins ( Site 2802)

Lima, 15072, Peru

RECRUITING

Hospital Nacional Dos De Mayo ( Site 2804)

Lima, 15087, Peru

RECRUITING

Pratia MCM Krakow ( Site 1303)

Krakow, Lesser Poland Voivodeship, 30-727, Poland

RECRUITING

Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 1305)

Wałbrzych, Lower Silesian Voivodeship, 58-309, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site 1301)

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

COMPLETED

Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologii i Transplantacji Szpiku ( Site 1304)

Lublin, Lublin Voivodeship, 20-090, Poland

COMPLETED

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 1300)

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1302)

Gdynia, Pomeranian Voivodeship, 81-519, Poland

COMPLETED

Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 1309)

Słupsk, Pomeranian Voivodeship, 76-200, Poland

RECRUITING

Pratia Onkologia Katowice ( Site 1306)

Katowice, Silesian Voivodeship, 40-519, Poland

RECRUITING

Seoul National University Hospital-Oncology ( Site 0302)

Seoul, 03080, South Korea

RECRUITING

Samsung Medical Center ( Site 0300)

Seoul, 06351, South Korea

COMPLETED

Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 0400)

Bangkok, Bangkok, 10700, Thailand

ACTIVE NOT RECRUITING

Chulalongkorn University ( Site 0402)

Pathumwan, Bangkok, 10330, Thailand

ACTIVE NOT RECRUITING

Maharaj Nakorn Chiang Mai Hospital ( Site 0401)

Chiang Mai, 50200, Thailand

ACTIVE NOT RECRUITING

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1912)

Yenimahalle, Ankara, 06200, Turkey (Türkiye)

RECRUITING

Ege University Medicine of Faculty ( Site 1902)

Bornova, İzmir, 35100, Turkey (Türkiye)

RECRUITING

Ankara University Hospital Cebeci-hematology ( Site 1901)

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Mega Medipol-Hematology ( Site 1909)

Istanbul, 34214, Turkey (Türkiye)

RECRUITING

Dokuz Eylül Üniversitesi-Hematology ( Site 1905)

Izmir, 35340, Turkey (Türkiye)

RECRUITING

Ondokuz Mayıs Universitesi ( Site 1907)

Samsun, 55139, Turkey (Türkiye)

COMPLETED

MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2000)

Cherkasy, Cherkasy Oblast, 18009, Ukraine

RECRUITING

Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 2004)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine

RECRUITING

Institute of Blood Pathology and Transfusion Medicine AMS Ukraine ( Site 2002)

Lviv, Lviv Oblast, 79057, Ukraine

RECRUITING

State non-profit enterprise National Cancer Institute ( Site 2001)

Kyiv, 03022, Ukraine

RECRUITING

National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine ( Site 2005)

Kyiv, 03115, Ukraine

RECRUITING

Aberdeen Royal Infirmary ( Site 2104)

Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom

RECRUITING

The Royal Cornwall Hospital ( Site 2103)

Truro, England, TR1 3LJ, United Kingdom

RECRUITING

University College London Hospital-Cancer Clinical Trials Unit ( Site 2100)

London-Camden, London, City of, NW1 2PG, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Gemcitabine; Oxaliplatin; Bendamustine Hydrochloride; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Butyrates; Acids, Acyclic; Carboxylic Acids; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In Part 1, Dose Confirmation will be determined by modified toxicity probability interval (mTPI) design, where participants will be assigned to two treatment groups, cohort: A (zilovertamab vedotin in combinatio with R-GemOx) in parallel with cohort B (zilovertamab vedotin in combination with BR). Part 2 will be an Efficacy Expansion (cohorts A \& B) where all participants in each cohort will be assigned to 2 treatment groups for the duration of the study.

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 1, 2021
• Study Start: January 14, 2022
• Primary Completion (Estimated): September 24, 2027
• Study Completion (Estimated): September 24, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (3); CL (7); NZ (1); KR (2); IL (3); UA (5); AR (5); TH (3); PL (8); FR (2); CA (1); CO (5); JP (4); TU (6); GB (3); GU (3); CN (16); US (23); AU (3); HK (2); PE (5); IT (4); ME (3); GR (3)