Chronic Lymphocytic Leukemia Clinical Trial

A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)

Summary

The purpose of this study is to assess the safety and tolerability of zilovertamab vedotin as monotherapy and in combination with nemtabrutinib in participants with select B-cell lymphomas including mantle cell lymphoma (MCL), Richter's transformation lymphoma (RTL), follicular lymphoma (FL), and leukemia-cll/" >chronic lymphocytic leukemia (CLL). This study will also evaluate zilovertamab vedotin as monotherapy and in combination with nemtabrutinib with respect to objective response rate.

MCL: relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor (BTKi), and post therapy chimeric antigen receptor T (CAR-T) cell therapy or ineligible for CAR-T cell therapy
RT: relapsed or refractory disease after at least 1 prior systemic therapy
MCL: relapsed or refractory disease after at least 1 prior systemic therapy and no prior exposure to a non-covalent BTKi
FL and CLL: relapsed or refractory disease after at least 2 prior systemic therapies and have no other available therapy

The primary study hypothesis is that zilovertamab vedotin monotherapy has an increased Objective Response Rate (ORR) per Lugano Response Criteria as assessed by blinded independent central review (BICR).

View Eligibility Criteria

Eligibility Criteria

The main inclusion criteria include, but are not limited to the following:

Inclusion Criteria:

For aggressive B-cell malignancies MCL and 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.

Exclusion Criteria:

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 unstable angina 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, including investigational agents, within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibodies) or 2 weeks (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 MCL, has any clinically significant gastrointestinal abnormalities that might alter absorption.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

275

Study ID:

NCT05458297

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 30 Locations for this study

See Locations Near You

Cancer Care Specialists of Illinois ( Site 0031)
Decatur Illinois, 62526, United States More Info
Study Coordinator
Contact
217-690-7045
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007)
Saint Matthews Kentucky, 40207, United States More Info
Study Coordinator
Contact
502-899-3366
Medical Oncology Associates, PS ( Site 0005)
Spokane Washington, 99208, United States More Info
Study Coordinator
Contact
509-462-2273
BC Cancer Vancouver-Clinical Trials Unit ( Site 0201)
Vancouver British Columbia, V5Z 4, Canada More Info
Study Coordinator
Contact
6048776000672017
IC La Serena Research ( Site 1909)
La Serena Coquimbo, 17000, Chile More Info
Study Coordinator
Contact
+56993718661
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907)
Santiago Region M. De Santiago, 75006, Chile More Info
Study Coordinator
Contact
569 9789 0202
Sun Yat-sen University Cancer Center ( Site 1201)
Guangzhou Guangdong, 51006, China More Info
Study Coordinator
Contact
13798101121
The First Affiliated Hospital of Nanchang University ( Site 1204)
Nanchang Jiangxi, 33000, China More Info
Study Coordinator
Contact
13970038386
Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0300)
Brno Brno-mesto, 625 0, Czechia More Info
Study Coordinator
Contact
420532233642
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302)
Praha 2 , 12808, Czechia More Info
Study Coordinator
Contact
+420 224 962 527
North Estonia Medical Centre Foundation ( Site 0401)
Tallinn Harjumaa, 13419, Estonia More Info
Study Coordinator
Contact
+3726172177
Soroka Medical Center-Hematology Department ( Site 0707)
Be'er Sheva , 84101, Israel More Info
Study Coordinator
Contact
97286403827
Hadassah Medical Center ( Site 0701)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
97226778180
Sheba Medical Center-Hemato Oncology ( Site 0700)
Ramat Gan , 52621, Israel More Info
Study Coordinator
Contact
+972526667154
IRCCS - AOU di Bologna-SSD: Diagnosi e terapie dei linfomi e delle sindromi linfoproliferative cron
Bologna Emilia-Romagna, 40138, Italy More Info
Study Coordinator
Contact
+390516363680
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0802)
Rozzano Milano, 20089, Italy More Info
Study Coordinator
Contact
390282244080
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare -Azienda Ospedaliera Nazionale SS. Ant
Alessandria , 15121, Italy More Info
Study Coordinator
Contact
+390131206262
Seoul National University Hospital ( Site 1300)
Seoul , 03080, Korea, Republic of More Info
Study Coordinator
Contact
+82220721672
Samsung Medical Center ( Site 1301)
Seoul , 06351, Korea, Republic of More Info
Study Coordinator
Contact
+82221487390
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumat-Oddiał Hematologii Ogólnej ( Site 1008)
Łódź Lodzkie, 93-51, Poland More Info
Study Coordinator
Contact
+48426895191
Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologiczny ( Site 1006)
Lublin Lubelskie, 20-09, Poland More Info
Study Coordinator
Contact
+48 81 454 1221
Pratia MCM Krakow ( Site 1001)
Krakow Malopolskie, 30-51, Poland More Info
Study Coordinator
Contact
+48602338290
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
Warszawa Mazowieckie, 02-78, Poland More Info
Study Coordinator
Contact
+48225462223
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Sit
Olsztyn Warminsko-mazurskie, 10-22, Poland More Info
Study Coordinator
Contact
+485398757
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 4003)
L'Hospitalet Del Llobregat Barcelona, 08908, Spain More Info
Study Coordinator
Contact
0034932607750
Hospital Universitari Vall d'Hebron ( Site 4004)
Barcelona , 08035, Spain More Info
Study Coordinator
Contact
0034932746000
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca-Hematology ( S
Salamanca , 37007, Spain More Info
Study Coordinator
Contact
913908546
Skånes Universitetssjukhus Lund ( Site 5000)
Lund Skane Lan, 22185, Sweden More Info
Study Coordinator
Contact
0046 (0)46177520
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 5002)
Uppsala Uppsala Lan, 751 8, Sweden More Info
Study Coordinator
Contact
0046 (0)186110000
Trakya University ( Site 6005)
Edirne , 22030, Turkey More Info
Study Coordinator
Contact
+905335544797

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

275

Study ID:

NCT05458297

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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