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)

Last updated: October 10, 2024
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

2

Condition

Lymphoma

Treatment

Prednisone

Zilovertamab Vedotin

Rituximab Biosimilar

Clinical Study ID

NCT05406401
2140-007
2021-005861-41
MK-2140-007
U1111-1280-2348
2022-501380-40
  • Ages > 18
  • All Genders

Study Summary

This study consists of a dose escalation/confirmation phase and an efficacy expansion phase. The dose escalation/confirmation phase is to determine the safety and tolerability and establish a preliminary recommended Phase 2 dose (RP2D) of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease. The efficacy expansion phase is to determine the efficacy of the RP2D of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease.

Eligibility Criteria

Inclusion

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion:

  • 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

Study Design

Total Participants: 60
Treatment Group(s): 7
Primary Treatment: Prednisone
Phase: 2
Study Start date:
July 14, 2022
Estimated Completion Date:
April 26, 2029

Connect with a study center

  • BC Cancer Victoria-Clinical Trials Unit ( Site 0105)

    Victoria, British Columbia V8R 6V5
    Canada

    Site Not Available

  • William Osler Health System ( Site 0106)

    Toronto, Ontario L6R3J7
    Canada

    Site Not Available

  • Hopital du Sacre-Coeur de Montreal ( Site 0108)

    Montreal, Quebec H4J 1C5
    Canada

    Site Not Available

  • Hadassah Medical Center ( Site 0401)

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Sheba Medical Center-Hemato Oncology ( Site 0400)

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 0306)

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Ospedale San Raffaele-Unità Linfomi ( Site 0305)

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-EMATOLOGIA I ( Site 0307)

    Palermo, Sicilia 90146
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi-SOD Ematologia ( Site 0308)

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant

    Alessandria, 15121
    Italy

    Site Not Available

  • Samsung Medical Center ( Site 0200)

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital ( Site 0201)

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 0503)

    Łódź, Lodzkie 93-513
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site

    Warszawa, Mazowieckie 02-781
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0504)

    Gdańsk, Pomorskie 80-214
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0505)

    Gliwice, Slaskie 44-101
    Poland

    Site Not Available

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Hematology ( Site 0704)

    Sevilla, Andalucia 41013
    Spain

    Site Not Available

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 0703)

    L'Hospitalet Del Llobregat, Barcelona 08908
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0700)

    Madrid, 28040
    Spain

    Site Not Available

  • Mega Medipol-Hematology ( Site 0808)

    Stanbul, Istanbul 34214
    Turkey

    Site Not Available

  • Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 0801)

    Ankara, 06620
    Turkey

    Site Not Available

  • Trakya University ( Site 0805)

    Edirne, 22030
    Turkey

    Site Not Available

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