Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
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)
Study ID: NCT05406401
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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), Roma, Lazio, Italy
Ospedale San Raffaele-Unità Linfomi ( Site 0305), Milano, Lombardia, Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-EMATOLOGIA I ( Site 0307), Palermo, Sicilia, Italy
Azienda Ospedaliera Universitaria Careggi-SOD Ematologia ( Site 0308), Firenze, Toscana, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant, Alessandria, , Italy
Seoul National University Hospital ( Site 0201), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 0200), Seoul, , Korea, Republic of
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 0503), Łódź, Lodzkie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0504), Gdańsk, Pomorskie, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0505), Gliwice, Slaskie, Poland
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Hematology ( Site 0704), Sevilla, Andalucia, 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
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 0801), Ankara, , Turkey
Trakya University ( Site 0805), Edirne, , Turkey
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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