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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

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