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)
Purpose
The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.
Conditions
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 known additional malignancy that is progressing or has required active treatment within the past 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, including intravenous (IV) antibiotics during screening. - Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Nemtabrutinib |
Participants will receive nemtabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met. |
|
|
Active Comparator Ibrutinib/Acalabrutinib |
Participants will receive investigator's choice of ibrutinib or acalabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met. |
|
Recruiting Locations
Mobile, Alabama 36604
Study Coordinator
251-665-8000
Gilbert, Arizona 85234
Study Coordinator
480-256-5490
Phoenix, Arizona 85006
Study Coordinator
480-256-5490
Berkeley, California 94704
Study Coordinator
510-204-3428
La Jolla, California 92093-0698
Study Coordinator
858-534-5201
Denver, Colorado 80218
Study Coordinator
303-403-6381
Golden, Colorado 80401
Study Coordinator
303-403-6381
Grand Junction, Colorado 81501
Study Coordinator
970-298-7638
Norwich, Connecticut 06360
Study Coordinator
860-886-8362
Clermont, Florida 34711
Study Coordinator
386-538-3169
Fort Myers, Florida 33901
Study Coordinator
239-274-9930
West Palm Beach, Florida 33401
Study Coordinator
727-216-1143
Fort Wayne, Indiana 46845
Study Coordinator
260-266-7100
Waukee, Iowa 50263
Study Coordinator
319-356-1616
Waukee, Iowa 50263
Study Coordinator
319-356-1616
Edgewood, Kentucky 41017
Study Coordinator
859-301-2000
Grand Rapids, Michigan 49503
Study Coordinator
616-267-7566
Saint Louis Park, Minnesota 55416
Study Coordinator
952-993-3252
Kansas City, Missouri 64132
Study Coordinator
816-974-5050
Billings, Montana 59102
Study Coordinator
406-238-6685
Hackensack, New Jersey 07601
Study Coordinator
551-996-3277
Buffalo, New York 14263
Study Coordinator
716-845-2300
Charlotte, North Carolina 28207
Study Coordinator
704-342-1900
Goldsboro, North Carolina 27534
Study Coordinator
919-587-9088
Broomall, Pennsylvania 19008
Study Coordinator
610-585-6287
York, Pennsylvania 17403
Study Coordinator
717-741-9229
Chattanooga, Tennessee 37404
Study Coordinator
615-986-4350
Nashville, Tennessee 37203
Study Coordinator
615-986-4350
Austin, Texas 78705
Study Coordinator
512-421-4100
Fort Worth, Texas 76104
Study Coordinator
817-759-7013
San Antonio, Texas 78217
Study Coordinator
210-419-2608
Tyler, Texas 75702
Study Coordinator
903-579-9800
Charlottesville, Virginia 22903
Study Coordinator
434-243-2649
Fairfax, Virginia 22031
Study Coordinator
571-472-4724
Richmond, Virginia 23298
Study Coordinator
804-628-2072
Spokane, Washington 99208
Study Coordinator
509-462-2273
Madison, Wisconsin 53715
Study Coordinator
608-410-2700
Madison, Wisconsin 53792
Study Coordinator
608-263-6400
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC