A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
Purpose
Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy. The goals of this study are to learn: - About the safety of MK-1045 and rituximab, and if people tolerate them when given together - If people who receive MK-1045 and rituximab have the cancer go away - If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)
Condition
- Follicular Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5. - Has radiographically measurable disease per the Lugano Response Criteria. - Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated. - If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART). - If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it. - If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
Exclusion Criteria
- Has received prior systemic anticancer therapy or radiotherapy for FL. - Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL. - Has FL that has transformed into a more aggressive type of lymphoma. - History or presence of clinically relevant central nervous system (CNS) diseases. - Has history of serious cardiovascular and cerebrovascular diseases. - Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. - Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. - Has known active CNS lymphoma or involvement. - Has an active autoimmune disease that has required systemic treatment in the past 2 years. - Has active infection requiring systemic therapy. - Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C. - Has not adequately recovered from major surgery or has ongoing surgical complications.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1: MK-1045 plus Rituximab (or biosimilar) |
Participants will receive escalating doses of MK-1045 (from 2 mg to 90 mg) once weekly (QW) for up to approximately 12 months. Participants will also receive 375 mg/m^2 rituximab (or biosimilar) once every 4 weeks (Q4W) for up to approximately 6 months. |
|
|
Experimental Part 2: MK-1045 plus Rituximab (or biosimilar) |
Participants will receive MK-1045 QW at the dose determined in Part 1 for up to approximately 12 months. Participants will also receive 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months. |
|
|
Experimental Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar) |
Participants will receive physician's choice of: 90 mg/m^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 1.4 mg/m^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m^2 cyclophosphamide and 1.4 mg/m^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 6 months. |
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Recruiting Locations
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
Study Coordinator
844-482-4812
Study Coordinator
844-482-4812
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC