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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)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: A Multicenter, Open-label, Phase 2 Dose Escalation and Confirmation, and Efficacy Expansion Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP in Participants With DLBCL (waveLINE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2022-07-14
Completion Date
2029-04-26
Last Updated
2024-10-15
Healthy Volunteers
No
Conditions
Interventions
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)
Locations (22)
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)