A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
Launched by MERCK SHARP & DOHME LLC · Nov 13, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called nemtabrutinib (MK-1026) to see how it compares to two existing treatments, ibrutinib and acalabrutinib, for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received treatment before. The main goals are to determine if nemtabrutinib works just as well as the other medications in helping patients respond to the treatment and if it can help them live longer without the disease getting worse.
To be eligible for this trial, participants must have a confirmed diagnosis of CLL or SLL and show signs that they need treatment. They should be between the ages of 65 and 74, have a good ability to perform daily activities, and be able to take oral medications. The trial is currently looking for participants and aims to provide them with close monitoring and support throughout the study. It’s important to note that individuals with certain health conditions or active infections may not be eligible to participate.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- The main inclusion criteria include but are not limited to the following:
- • Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
- • Has at least 1 marker of disease burden.
- • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.
- • 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 deoxyribonucleic acid (DNA) viral load before randomization.
- • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.
- • Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.
- Exclusion Criteria:
- The main exclusion criteria include but are not limited to the following:
- • Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
- • Has gastrointestinal (GI) dysfunction that may affect drug absorption.
- • Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
- • Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.
- • Has clinically significant cardiovascular disease.
- • Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.
- • Has history of severe bleeding disorder.
- • Has history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- • Has received any systemic anticancer therapy for CLL/SLL.
- • Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.
- • Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- • Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.
- • Has active infection requiring systemic therapy.
- • Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bangkok, Krung Thep Maha Nakhon, Thailand
Warszawa, Mazowieckie, Poland
Olsztyn, Warminsko Mazurskie, Poland
Spokane, Washington, United States
Jerusalem, , Israel
Tainan, , Taiwan
Taoyuan, , Taiwan
Ramat Gan, , Israel
York, Pennsylvania, United States
Oxford, Oxfordshire, United Kingdom
Praha 2, , Czechia
Newmarket, Suffolk, United Kingdom
Santiago, Region M. De Santiago, Chile
Ramat Gan, , Israel
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Zerifin, , Israel
Windsor, Windsor And Maidenhead, United Kingdom
Ottawa, Ontario, Canada
Haifa, , Israel
Izumo, Shimane, Japan
Madison, Wisconsin, United States
Yamagata, , Japan
Iowa City, Iowa, United States
Sao Paulo, , Brazil
Rimouski, Quebec, Canada
London, London, City Of, United Kingdom
Florham Park, New Jersey, United States
Zerifin, , Israel
Kobe, Hyogo, Japan
Chiba, , Japan
São Paulo, Sao Paulo, Brazil
Koto, Tokyo, Japan
Osaka, , Japan
Fort Wayne, Indiana, United States
Bristol, Bristol, City Of, United Kingdom
Stockholm, Stockholms Lan, Sweden
Guangzhou, Guangdong, China
Guiyang, Guizhou, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Nanchang, Jiangxi, China
Tianjin, Tianjin, China
Urumqi, Xinjiang, China
Chiba, , Japan
Brampton, Ontario, Canada
Liuzhou, Guangxi, China
Nanchang, Jiangxi, China
Haifa, , Israel
Sendai, Miyagi, Japan
Kaohsiung, , Taiwan
Taipei, , Taiwan
Hackensack, New Jersey, United States
Hefei, Anhui, China
Beijing, Beijing, China
Nagoya, Aichi, Japan
Osaka Sayama, Osaka, Japan
Okayama, , Japan
Barnet, , United Kingdom
Mobile, Alabama, United States
Berkeley, California, United States
Xian, Shaanxi, China
Tianjin, Tianjin, China
Valledupar, Cesar, Colombia
Montería, Cordoba, Colombia
Cali, Valle Del Cauca, Colombia
Guangzhou, Guangdong, China
Changsha, Hunan, China
Jinan, Shandong, China
Rio De Janeiro, , Brazil
Hefei, Anhui, China
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Chongqing, Chongqing, China
Nanning, Guangxi, China
Haikou, Hainan, China
Suzhou, Jiangsu, China
Xuzhou, Jiangsu, China
Changchun, Jilin, China
Taiyuan, Shanxi, China
Berlin, , Germany
Petah Tikva, , Israel
Maebashi, Gunma, Japan
Sapporo, Hokkaido, Japan
Fukuoka, , Japan
Hiroshima, , Japan
George Town, Pulau Pinang, Malaysia
Auckland, , New Zealand
Auckland, , New Zealand
Oslo, , Norway
Arequipa, Ariqipa, Peru
Centurion, Gauteng, South Africa
Kuilsriver, Western Cape, South Africa
Plumstead, Western Cape, South Africa
L'hospitalet Del Llobregat, Barcelona, Spain
Barcelona, Cataluna, Spain
Majadahonda, Madrid, Comunidad De, Spain
Pozuelo De Alarcon, Madrid, Spain
La Laguna, Santa Cruz De Tenerife, Spain
Salamanca, , Spain
Taoyuan, , Taiwan
Muang, Chiang Mai, Thailand
Bangkok, Krung Thep Maha Nakhon, Thailand
Muang, Phitsanulok, Thailand
Hatyai, Songkhla, Thailand
Leeds, , United Kingdom
Grand Rapids, Michigan, United States
Olomouc, , Czechia
Lima, , Peru
Porto, , Portugal
Montréal, Quebec, Canada
Hong Kong, , Hong Kong
Barcelona, , Spain
Changsha, Hunan, China
Nanjing, Jiangsu, China
Urumqi, Xinjiang, China
Hamilton, Waikato, New Zealand
Zhengzhou, Henan, China
Cheng Du, Sichuan, China
Mönchengladbach, Nordrhein Westfalen, Germany
Katowice, Slaskie, Poland
Mechelen, Antwerpen, Belgium
Leuven, Vlaams Brabant, Belgium
Roskilde, Sjaelland, Denmark
Odense C, Syddanmark, Denmark
Beijing, Beijing, China
Hangzhou, Zhejiang, China
Aalborg, Nordjylland, Denmark
Lørenskog, Akershus, Norway
Gliwice, Slaskie, Poland
Koblenz, Rheinland Pfalz, Germany
Zerifin, , Israel
Cape Town, Western Cape, South Africa
Hradec Kralove, , Czechia
Halle, Sachsen Anhalt, Germany
Ankara, , Turkey
Victoria, British Columbia, Canada
Nanning, Guangxi, China
Fairfax, Virginia, United States
Landshut, Bayern, Germany
Alexandroupolis, Anatoliki Makedonia Kai Thraki, Greece
Athens, Attiki, Greece
Ioannina, , Greece
Petah Tikva, , Israel
Krakow, Malopolskie, Poland
St Leonards, New South Wales, Australia
Hangzhou, Zhejiang, China
Izumo, Shimane, Japan
Gdansk, Pomorskie, Poland
Lisbon, Lisboa, Portugal
Lisbon, Lisboa, Portugal
Lisboa, , Portugal
Johannesburg, Gauteng, South Africa
Ankara, , Turkey
Edirne, , Turkey
La Jolla, California, United States
Taiyuan, Shanxi, China
Istanbul, , Turkey
Ulm, Baden Wurttemberg, Germany
Słupsk, Pomorskie, Poland
Changsha, Hunan, China
Kota Kinabalu, Sabah, Malaysia
Ciudad De México, Distrito Federal, Mexico
Vila Nova De Gaia, Porto, Portugal
Fort Myers, Florida, United States
West Palm Beach, Florida, United States
Antalya, , Turkey
Lisbon, Lisboa, Portugal
İzmir, , Turkey
Wuhan, Hubei, China
Wuhan, Hubei, China
Sayama, Osaka, Japan
Osaka, , Japan
Santiago, Region M. De Santiago, Chile
Koto, Tokyo, Japan
Lublin, Lubelskie, Poland
Lembah Pantai, Kuala Lumpur, Malaysia
Nottingham, , United Kingdom
Santiago., Region M. De Santiago, Chile
Wuhan, Hubei, China
Ciudad De México, Distrito Federal, Mexico
Prescott, Arizona, United States
Broomall, Pennsylvania, United States
Austin, Texas, United States
Ulm, Baden Wurttemberg, Germany
Koto, Tokyo, Japan
Lisboa, , Portugal
Samsun, , Turkey
San Antonio, Texas, United States
Tyler, Texas, United States
Monteria, Cordoba, Colombia
Denver, Colorado, United States
Golden, Colorado, United States
Edgewood, Kentucky, United States
Grand Junction, Colorado, United States
Buffalo, New York, United States
Ulm, Baden Wurttemberg, Germany
Norwich, Connecticut, United States
Athens, Attiki, Greece
Rimouski, Quebec, Canada
Lublin, Lubelskie, Poland
Warszawa, Mazowieckie, Poland
Słupsk, Pomorskie, Poland
Olsztyn, Warminsko Mazurskie, Poland
Saint Louis Park, Minnesota, United States
Fort Worth, Texas, United States
Wuhan, Hebei, China
Richmond, Virginia, United States
Clermont, Florida, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Lublin, Lubelskie, Poland
Majadahonda, , Spain
Bristol, , United Kingdom
London, , United Kingdom
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported