Informations générales (source: ClinicalTrials.gov)
A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)
Interventional
Phase 3
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
janvier 2025
mars 2032
29 juillet 2025
The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment
can help people live longer without the cancer growing or spreading than people who
receive standard treatment alone.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC RENE HUGUENIN INSTITUT CURIE | Study Coordinator | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine-Lacassagne ( Site 1514) - 06189 - Nice - Alpes-Maritimes - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Centre Hospitalier d'Avignon ( Site 1505) - 84000 - Avignon - Vaucluse - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Dunkerque ( Site 1513) - 59385 - Dunkerque - Nord - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de la Cote Basque ( Site 1509) - 64100 - Bayonne - Pyrenees-Atlantiques - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy ( Site 1515) - 57085 - Metz - Moselle - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1512) - 87042 - Limoges - Limousin - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire Estaing ( Site 1508) - 63100 - Clermont-Ferrand - Puy-de-Dome - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| CHD Vendee ( Site 1502) - 85000 - La Roche-sur-Yon - Vendee - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| CHU Dijon Bourgogne ( Site 1516) - 21000 - Dijon - Cote-d Or - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| HIA Sainte Anne ( Site 1506) - 83800 - Toulon - Var - France | Study Coordinator | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by
prior biopsy, based on local testing according to the WHO classification of
neoplasms of the hematopoietic and lymphoid tissues
- Has positron emission tomography (PET) positive disease at screening, defined as 4
to 5 on the Lugano 5-point scale
- Has received no prior treatment for their DLBCL
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
assessed within 7 days before randomization
- Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or
multigated acquisition (MUGA)
- Human immunodeficiency virus (HIV) infected participants must have well controlled
HIV on antiretroviral therapy (ART)
- Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have
received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral
load prior to randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV
viral load is undetectable at screening
- Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by
prior biopsy, based on local testing according to the WHO classification of
neoplasms of the hematopoietic and lymphoid tissues
- Has positron emission tomography (PET) positive disease at screening, defined as 4
to 5 on the Lugano 5-point scale
- Has received no prior treatment for their DLBCL
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
assessed within 7 days before randomization
- Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or
multigated acquisition (MUGA)
- Human immunodeficiency virus (HIV) infected participants must have well controlled
HIV on antiretroviral therapy (ART)
- Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have
received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral
load prior to randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV
viral load is undetectable at screening
- Has a history of transformation of indolent disease to DLBCL
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone
lymphoma
- Has Ann Arbor Stage I DLBCL
- Has clinically significant (i.e., 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 clinically significant pericardial or pleural effusion
- Has ongoing Grade >1 peripheral neuropathy
- Has a demyelinating form of Charcot-Marie-Tooth disease
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric
Castleman's Disease
- Has ongoing corticosteroid therapy
- Has received a live or live-attenuated vaccine within 30 days before the first dose
of study intervention. Administration of killed vaccines is allowed
- Known additional malignancy that is progressing or has required active treatment
within the past 2 years
- Known active central nervous system (CNS) lymphoma
- Has active autoimmune disease that has required systemic treatment in the past 2
years
- Has active infection requiring systemic therapy
- Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV
(defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA))
infection
- Has history of allogeneic tissue/solid organ transplant