Last updated 8 days ago
A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)
223 patients around the world
Available in Chile, Peru, Brazil
Merck Sharp & Dohme LLC
10Research sites
223Patients around the world
This study is for people with
Leukemia
Chronic lymphocytic leukemia
Non-Hodgkin Lymphoma
Mantle cell lymphoma
Follicular lymphoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- For aggressive B-cell malignancies MCL: Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor(s) (BTKi), and is post chimeric antigen receptor T (CAR-T) cell therapy or is ineligible for CAR-T cell therapy.For aggressive B-cell malignancies MCL Cohort C: Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease after at least 1 prior systemic therapy and has no prior exposure to a non-covalent BTKi.For aggressive B-cell malignancies Richter transformation lymphoma (RTL): Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease.For indolent B-cell malignancies FL and CLL: Has histologically confirmed biopsy and has relapsed or refractory disease after at least 2 prior systemic therapies and no other available therapy.Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization/allocation.Have an ECOG performance status of 0 to 2 assessed within 7 days before cycle 1 day 1.
- Has received solid organ transplant at any time.Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina (<6 months prior to enrollment), congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.Has pericardial effusion or clinically significant pleural effusion.Has ongoing Grade >1 peripheral neuropathy.Has a demyelinating form of Charcot-Marie-Tooth disease.Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.Participants with FL who have transformed to a more aggressive type of lymphoma.Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibodies) or 2 weeks (if prior therapy was small molecules like kinase inhibitors) prior to the first dose of study intervention.Has received prior radiotherapy within 28 days of start of study intervention. Participants must have recovered from all radiation-related toxicities.Has ongoing corticosteroid therapy exceeding 30 mg daily of prednisone equivalent.Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma.Has an active infection requiring systemic therapy.Has a known history of human immunodeficiency virus (HIV) infection.Active HBV or hepatitis C virus (HCV) infection.For Cohort C only: has any clinically significant gastrointestinal abnormalities that might alter absorption.
Sites
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Recruiting
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Recruiting
Hospital Paulistano
Recruiting
Centro de Estudios Clínicos SAGA - CECSAGA
Recruiting
IC La Serena Research - La Serena
Recruiting
Inmunocel
Recruiting
Clínica Alemana
Recruiting
Instituto Nacional de Enfermedades Neoplásicas
Recruiting
Centro Medico Monte Carmelo
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Chronic lymphocytic leukemiaMantle cell lymphomaFollicular lymphoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05458297
