A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)
NCT ID: NCT05406401
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2022-07-14
2029-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Zilovertamab Vedotin + R-CHP: Dose Escalation/Confirmation
Participants in the dose escalation/confirmation phase receive a dose level of zilovertamab vedotin (from 1.5 mg/Kg up to 2.5 mg/Kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar (truxima) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 8 cycles (up to approximately 5.5 months). Participants also receive 100 mg prednisone or prednisolone per day during Days 1-5 of each 21-day cycle for up to 8 cycles (up to approximately 5.5 months).
Zilovertamab Vedotin
IV infusion
Cyclophosphamide
IV infusion
Doxorubicin
IV infusion
Rituximab
IV infusion
Rituximab Biosimilar
IV infusion
Prednisone
IV or oral administration (per local guidelines)
Prednisolone
IV or oral administration (per local guidelines)
Zilovertamab Vedotin + R-CHP: Efficacy Expansion
Participants in the efficacy expansion phase receive the RP2D of zilovertamab vedotin plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar (truxima) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 8 cycles (up to approximately 5.5 months). Participants also receive 100 mg prednisone or prednisolone per day during Days 1-5 of each 21-day cycle for up to 8 cycles (up to approximately 5.5 months).
Zilovertamab Vedotin
IV infusion
Cyclophosphamide
IV infusion
Doxorubicin
IV infusion
Rituximab
IV infusion
Rituximab Biosimilar
IV infusion
Prednisone
IV or oral administration (per local guidelines)
Prednisolone
IV or oral administration (per local guidelines)
Interventions
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Zilovertamab Vedotin
IV infusion
Cyclophosphamide
IV infusion
Doxorubicin
IV infusion
Rituximab
IV infusion
Rituximab Biosimilar
IV infusion
Prednisone
IV or oral administration (per local guidelines)
Prednisolone
IV or oral administration (per local guidelines)
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* Has histologically confirmed diagnosis of DLBCL by prior biopsy
* Has PET-positive disease verified by blinded independent central review (BICR) at screening, defined as 4-5 on the Lugano response criteria 5-point scale
* Has received no prior treatment for DLBCL
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days prior to the start of study intervention
Exclusion:
* Has a 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: 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 pericardial effusion or clinically significant pleural effusion
* Has ongoing Grade \>1 peripheral neuropathy
* Has a demyelinating form of Charcot-Marie-Tooth disease
* History of a second malignancy unless potentially curative treatment has been completed with no evidence of malignancy for 2 years with the exception of participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous-cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
* Has received prior radiotherapy within 28 days of start of study intervention
* Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent)
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has received a strong inhibitor or inducer of CYP3A4 (including itraconazole, ketoconazole, posaconazole, or voriconazole) within 7 days prior to the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor until \<30 days after the last dose
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study intervention
* Has known active central nervous system (CNS) lymphoma
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known active hepatitis C virus infection
* Has a known active hepatitis B virus infection
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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BC Cancer Victoria-Clinical Trials Unit ( Site 0105)
Victoria, British Columbia, Canada
William Osler Health System ( Site 0106)
Toronto, Ontario, Canada
Hopital du Sacre-Coeur de Montreal ( Site 0108)
Montreal, Quebec, Canada
Hadassah Medical Center ( Site 0401)
Jerusalem, , Israel
Sheba Medical Center-Hemato Oncology ( Site 0400)
Ramat Gan, , Israel
Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 0306)
Rome, Lazio, Italy
Ospedale San Raffaele-Unità Linfomi ( Site 0305)
Milan, Lombardy, Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-EMATOLOGIA I ( Site 0307)
Palermo, Sicily, Italy
Azienda Ospedaliera Universitaria Careggi-SOD Ematologia ( Site 0308)
Florence, Tuscany, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant
Alessandria, , Italy
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0504)
Gdansk, Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0505)
Gliwice, Silesian Voivodeship, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 0503)
Lodz, Łódź Voivodeship, Poland
Seoul National University Hospital ( Site 0201)
Seoul, , South Korea
Samsung Medical Center ( Site 0200)
Seoul, , South Korea
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Hematology ( Site 0704)
Seville, Andalusia, Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 0703)
L'Hospitalet Del Llobregat, Barcelona, Spain
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0700)
Madrid, , Spain
Mega Medipol-Hematology ( Site 0808)
Stanbul, Istanbul, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 0801)
Ankara, , Turkey (Türkiye)
Trakya University ( Site 0805)
Edirne, , Turkey (Türkiye)
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-2140-007
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501380-40
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1280-2348
Identifier Type: OTHER
Identifier Source: secondary_id
2021-005861-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2140-007
Identifier Type: -
Identifier Source: org_study_id
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