A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies

Who is this study for? Patients with Hematologic Malignancies
What treatments are being studied? MK-1026
Status: Recruiting
Location: See all (119) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to allocation

• Has a life expectancy of at least 3 months, based on the investigator assessment

• Has the ability to swallow and retain oral medication

• 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

• Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

• Has adequate organ function

• Male participants agree to refrain from donating sperm and agree to either remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for at least the time required to eliminate the study intervention after last dose of study intervention

• Female participants assigned female sex at birth who are not pregnant or breastfeeding are eligible to participate if not a participant of childbearing potential (POCBP), or if a POCBP they either use a contraceptive method that is highly effective OR remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle during the intervention period and for at least to eliminate study intervention after the last dose of study intervention

• Participants with HIV are eligible if they meet all of the following: the CD4 count is \>350 cells/uL at screening, the HIV viral load is below the detectable level, are on a stable ART regimen for at least 4 weeks prior to study entry, and are compliant with their ART

∙ Part 1 and Part 2 (Cohorts A to C and J)

• Has a confirmed diagnosis of CLL/SLL with

‣ At least 2 lines of prior therapy (Part 1 only)

⁃ Part 2 Cohort A: CLL/SLL participants who are relapsed or refractory to prior therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi), and a B-cell lymphoma 2 inhibitor (BCL2i). CLL participants must have received and failed, been intolerant to, or determined by their treating physician to be a poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a PI3Ki per local guidelines

⁃ Part 2 Cohort B: CLL/SLL participants who are relapsed or refractory following at least 1 line of prior therapy and are BTKi treatment naive

⁃ Part 2 Cohort C: CLL/SLL participants with 17p deletion or tumor protein p53 (TP53) mutation who are relapsed or refractory following at least 1 line of prior therapy

⁃ Part 2 Cohort J: CLL/SLL participants whose disease relapsed or was refractory to prior therapy with a covalent/irreversible BTKi and BCL2i

⁃ Has active disease for CLL/SLL clearly documented to initiate therapy

⁃ Has evaluable core or excisional lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate at Screening (optional for participants enrolling in Part 1)

∙ Part 2 (Cohorts D to G)

• Has a confirmed diagnosis of and meets the following prior therapy requirements:

‣ Participants with Richter's transformation who are relapsed or refractory following at least 1 line of prior therapy (Cohort D)

⁃ Participants with pathologically confirmed MCL, documented by either overexpression of cyclin D1 or t(11;14), who are relapsed or are refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort E)

⁃ Participants with MZL (including splenic, nodal, and extra nodal MZL) who are relapsed or refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort F)

⁃ Participants with FL who are relapsed or refractory to chemoimmunotherapy, immunomodulatory agents (i.e. lenalidomide plus rituximab) (Cohort G)

• Have measurable disease defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan

• Has a lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate (Cohort D) at Screening

∙ Part 2 (Cohort H): confirmed diagnosis of WM; participants who are relapsed or refractory to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi

• Has active disease defined as 1 of the following: systemic symptoms, physical findings, laboratory abnormalities, coexisting disease

• Has measurable disease, satisfying any of the following: at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement must be \>15 mm in the longest diameter or \>10 mm in the short axis); IgM ≥450 mg/dL; or bone marrow infiltration of 10%

• Has fresh bone marrow aspirate or a lymph node biopsy for biomarker analysis at Screening or a lymph node biopsy from an archival

Locations
United States
Arkansas
Highlands Oncology Group ( Site 2728)
RECRUITING
Springdale
California
University of California San Diego Moores Cancer Center ( Site 2717)
RECRUITING
La Jolla
Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site
RECRUITING
Torrance
Colorado
Colorado Blood Cancer Institute ( Site 2726)
RECRUITING
Denver
Kentucky
The University of Louisville, James Graham Brown Cancer Center ( Site 2729)
RECRUITING
Louisville
Minnesota
Mayo Clinic - Rochester ( Site 2706)
RECRUITING
Rochester
North Dakota
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708)
COMPLETED
Fargo
New Jersey
Astera Cancer Care ( Site 2732)
RECRUITING
East Brunswick
John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)
RECRUITING
Hackensack
Texas
UT Southwestern-Harold C. Simmons Cancer Center ( Site 2730)
RECRUITING
Dallas
Washington
Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)
RECRUITING
Spokane
Other Locations
Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103)
RECRUITING
Buenos Aires
FUNDALEU ( Site 0104)
RECRUITING
Caba
Hospital Aleman ( Site 0102)
RECRUITING
Ciudad Autonoma De Buenos Aires
Hospital Privado Universitario de Córdoba ( Site 0107)
RECRUITING
Cordoba
Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0110)
COMPLETED
Mendoza
Fundacion Estudios Clinicos ( Site 0112)
RECRUITING
Rosario
Australia
Box Hill Hospital ( Site 0203)
RECRUITING
Box Hill
Sir Charles Gairdner Hospital ( Site 0200)
RECRUITING
Nedlands
Nepean Hospital-Nepean Cancer Care Centre ( Site 0204)
COMPLETED
Sydney
Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300)
RECRUITING
Rio De Janeiro
BP - A Beneficencia Portuguesa de São Paulo ( Site 0302)
ACTIVE_NOT_RECRUITING
Sao Paulo
Hospital Paulistano - Amil Clinical Research ( Site 0311)
RECRUITING
Sao Paulo
Hospital das Clinicas FMUSP-Pesquisa Clínica Hematologia ( Site 0303)
RECRUITING
São Paulo
Canada
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0401)
RECRUITING
Calgary
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0403)
RECRUITING
Montreal
Jewish General Hospital ( Site 0400)
RECRUITING
Montreal
The Ottawa Hospital ( Site 0404)
RECRUITING
Ottawa
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0406)
RECRUITING
Toronto
China
Peking University Third Hospital-Hematology ( Site 2827)
RECRUITING
Beijing
The First Hospital of Jilin University-Hematology ( Site 2803)
RECRUITING
Changchun
Hunan Cancer Hospital ( Site 2822)
RECRUITING
Changsha
The Second Xiangya Hospital of Central South University ( Site 2820)
RECRUITING
Changsha
West China Hospital Sichuan University ( Site 2810)
RECRUITING
Cheng Du
The Second Affiliated Hospital of Chongqing Medical University ( Site 2825)
RECRUITING
Chongqing
Sun Yat-sen University Cancer Center-Internal Medicine ( Site 2824)
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University ( Site 2826)
RECRUITING
Hangzhou
Anhui Provincial Hospital ( Site 2808)
RECRUITING
Hefei
Guangxi Medical University - Liuzhou Renmin Hospital ( Site 2817)
RECRUITING
Liuzhou
The First Affiliated Hospital of Nanchang University ( Site 2815)
RECRUITING
Nanchang
Jiangsu Province Hospital ( Site 2823)
RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital ( Site 2814)
RECRUITING
Nanning
Fudan University Shanghai Cancer Center ( Site 2801)
RECRUITING
Shanghai
Huashan Hospital, Fudan University ( Site 2821)
RECRUITING
Shanghai
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Unio
RECRUITING
Tianjin
Wuhan Union Hospital ( Site 2816)
RECRUITING
Wuhan
The Affiliated Hospital of Xuzhou Medical College ( Site 2818)
RECRUITING
Xuzhou
Henan Cancer Hospital-hematology department ( Site 2802)
RECRUITING
Zhengzhou
Denmark
Aalborg Universitetshospital ( Site 0703)
RECRUITING
Aalborg
Aarhus University Hospital ( Site 0702)
COMPLETED
Aarhus N
Odense University Hospital ( Site 0705)
COMPLETED
Odense C
Sjaellands Universitetshospital Roskilde ( Site 0701)
RECRUITING
Roskilde
France
Centre Hospitalier de Versailles ( Site 0809)
RECRUITING
Le Chesnay
Institut Paoli-Calmettes ( Site 0803)
RECRUITING
Marseille
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810)
RECRUITING
Nice
Hopital Saint Louis ( Site 0805)
RECRUITING
Paris
Centre Hospitalier Lyon-Sud ( Site 0804)
RECRUITING
Pierre Benite
Germany
Universitaetsklinikum Carl Gustav Carus ( Site 0902)
RECRUITING
Dresden
Universitaetsklinikum Koeln ( Site 0901)
RECRUITING
Koeln
St. Marien-Krankenhaus Siegen ( Site 0914)
COMPLETED
Siegen
Universitaetsklinikum Ulm ( Site 0906)
RECRUITING
Ulm
Hungary
Orszagos Onkologiai Intezet ( Site 1200)
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont ( Site 1201)
RECRUITING
Debrecen
Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 1206)
RECRUITING
Nyiregyhaza
Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202)
RECRUITING
Pecs
Ireland
Beaumont Hospital ( Site 2900)
RECRUITING
Dublin
University Hospital Limerick ( Site 2903)
RECRUITING
Limerick
Israel
Ha Emek Medical Center ( Site 1305)
RECRUITING
Afula
Soroka Medical Center ( Site 1307)
RECRUITING
Beer-sheva
Rambam Medical Center ( Site 1301)
RECRUITING
Haifa
Hadassah Ein Karem Jerusalem ( Site 1300)
RECRUITING
Jerusalem
Chaim Sheba Medical Center ( Site 1302)
RECRUITING
Ramat Gan
Kaplan Medical Center ( Site 1304)
RECRUITING
Rehovot
Sourasky Medical Center ( Site 1303)
RECRUITING
Tel Aviv
Italy
Istituto Tumori Giovanni Paolo II ( Site 1409)
RECRUITING
Bari
A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400)
RECRUITING
Bologna
ASST Spedali Civili di Brescia ( Site 1408)
RECRUITING
Brescia
IRCCS Ospedale San Raffaele ( Site 1402)
RECRUITING
Milano
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403)
RECRUITING
Napoli
Fondazione IRCCS Policlinico San Matteo ( Site 1407)
RECRUITING
Pavia
IRCCS - Arcispedale Santa Maria Nuova ( Site 1405)
RECRUITING
Reggio Emilia
Policlinico Umberto I ( Site 1404)
RECRUITING
Roma
Poland
Szpitale Pomorskie Sp. z o.o. ( Site 1600)
COMPLETED
Gdynia
Pratia MCM Krakow ( Site 1601)
RECRUITING
Krakow
Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607)
COMPLETED
Opole
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site
RECRUITING
Warszawa
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
RECRUITING
Wroclaw
Republic of Korea
Samsung Medical Center ( Site 2200)
RECRUITING
Seoul
Severance Hospital Yonsei University Health System ( Site 2201)
RECRUITING
Seoul
Romania
Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 1802)
RECRUITING
Brasov
Spitalul Clinic Colțea ( Site 1805)
RECRUITING
București
Institutul Regional de Oncologie Iasi ( Site 1801)
RECRUITING
Iasi
Ovidius Clinical Hospital ( Site 1804)
COMPLETED
Ovidiu
Spain
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2005)
RECRUITING
A Coruña
Hospital General Universitario de Alicante ( Site 2007)
RECRUITING
Alicante
Hospital Universitari Vall d'Hebron ( Site 2001)
RECRUITING
Barcelona
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000)
RECRUITING
Hospitalet De Llobregat
Hospital Universitario 12 de Octubre ( Site 2003)
RECRUITING
Madrid
Hospital Universitario de Salamanca ( Site 2002)
RECRUITING
Salamanca
Switzerland
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302)
RECRUITING
Bellinzona
Inselspital Bern ( Site 2303)
RECRUITING
Bern
Turkey
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400)
RECRUITING
Ankara
Sisli Florence Nightingale Hastanesi ( Site 2407)
RECRUITING
Istanbul
VKV Amerikan Hastanesi ( Site 2403)
COMPLETED
Istanbul
Dokuz Eylül Üniversitesi-Hematology ( Site 2402)
RECRUITING
Izmir
Mega Medipol-Hematology ( Site 2406)
RECRUITING
Stanbul
Ukraine
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( S
RECRUITING
Cherkassy
Communal non-profit enterprise Regional clinical hospital o-Hematology Department ( Site 2510)
COMPLETED
Ivano-frankivsk
Kyiv City Clinical Hospital 9 ( Site 2502)
RECRUITING
Kyiv
National Cancer Institute ( Site 2507)
RECRUITING
Kyiv
Instit. of Blood Transfusion Medicine of the National Academy ( Site 2506)
RECRUITING
Lviv
United Kingdom
Bristol Haematology and Oncology Centre ( Site 2610)
RECRUITING
Bristol
Sarah Cannon Research Institute UK ( Site 2612)
RECRUITING
London
The Christie NHS Foundation Trust ( Site 2602)
RECRUITING
Manchester
GenesisCare - Cambridge ( Site 2611)
RECRUITING
Newmarket
Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601)
RECRUITING
Nottingham
GenesisCare - Oxford ( Site 2607)
RECRUITING
Oxford
The Royal Marsden NHS Foundation Trust. ( Site 2606)
RECRUITING
Sutton
GenesisCare - Windsor ( Site 2608)
RECRUITING
Windsor
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2021-04-05
Estimated Completion Date: 2027-03-19
Participants
Target number of participants: 490
Treatments
Experimental: Nemtabrutinib
Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation.
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov