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 4076598, Alabama 4829764 36604
Study Coordinator
888-577-8839
Prescott 5309842, Arizona 5551752 86301
Study Coordinator
888-577-8839
Berkeley 5327684, California 5332921 94704
Study Coordinator
888-577-8839
La Jolla 5363943, California 5332921 92093-0698
Study Coordinator
888-577-8839
Denver 5419384, Colorado 5417618 80218
Study Coordinator
303-812-6998
Golden 5423294, Colorado 5417618 80401
Study Coordinator
303-403-3672
Grand Junction 5423573, Colorado 5417618 81501
Study Coordinator
970-298-7500
Norwich 4839843, Connecticut 4831725 06360
Study Coordinator
860-886-8362
Clermont 4151352, Florida 4155751 34711
Study Coordinator
386-538-3169
Fort Myers 4155995, Florida 4155751 33901
Study Coordinator
888-577-8839
West Palm Beach 4177887, Florida 4155751 33401
Study Coordinator
888-577-8839
Fort Wayne 4920423, Indiana 4921868 46845
Study Coordinator
260-266-7100
Waukee 4880981, Iowa 4862182 50263
Study Coordinator
319-356-1616
Waukee 4880981, Iowa 4862182 50263
Study Coordinator
319-356-1616
Edgewood 4290873, Kentucky 6254925 41017
Study Coordinator
888-577-8839
Grand Rapids 4994358, Michigan 5001836 49503
Study Coordinator
888-577-8839
Saint Louis Park 5045021, Minnesota 5037779 55416
Study Coordinator
952-993-3252
Kansas City 4393217, Missouri 4398678 64132
Study Coordinator
816-974-5050
Billings 5640350, Montana 5667009 59102
Study Coordinator
406-238-6685
Hackensack 5098706, New Jersey 5101760 07601
Study Coordinator
888-577-8839
Buffalo 5110629, New York 5128638 14263
Study Coordinator
888-577-8839
Charlotte 4460243, North Carolina 4482348 28207
Study Coordinator
704-342-1900
Goldsboro 4468261, North Carolina 4482348 27534
Study Coordinator
919-587-9088
Broomall 4556802, Pennsylvania 6254927 19008
Study Coordinator
888-577-8839
York 4562407, Pennsylvania 6254927 17403
Study Coordinator
888-577-8839
Chattanooga 4612862, Tennessee 4662168 37404
Study Coordinator
615-986-4350
Nashville 4644585, Tennessee 4662168 37203
Study Coordinator
615-986-4350
Austin 4671654, Texas 4736286 78705
Study Coordinator
888-577-8839
Fort Worth 4691930, Texas 4736286 76104
Study Coordinator
817-759-7013
San Antonio 4726206, Texas 4736286 78217
Study Coordinator
888-577-8839
Tyler 4738214, Texas 4736286 75702
Study Coordinator
888-577-8839
Charlottesville 4752031, Virginia 6254928 22903
Study Coordinator
434-243-2649
Fairfax 4758023, Virginia 6254928 22031
Study Coordinator
888-577-8839
Richmond 4781708, Virginia 6254928 23298
Study Coordinator
804-628-2072
Spokane 5811696, Washington 5815135 99208
Study Coordinator
888-577-8839
Madison 5261457, Wisconsin 5279468 53715
Study Coordinator
608-410-2700
Madison 5261457, Wisconsin 5279468 53792
Study Coordinator
888-577-8839
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC