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ACTIVE NOT RECRUITING
NCT05406401
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Zilovertamab Vedotin

IV infusion

DRUG

Cyclophosphamide

IV infusion

DRUG

Doxorubicin

IV infusion

BIOLOGICAL

Rituximab

IV infusion

BIOLOGICAL

Rituximab Biosimilar

IV infusion

DRUG

Prednisone

IV or oral administration (per local guidelines)

DRUG

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)