A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
Purpose
Researchers are looking for new ways to treat 2 types of non-Hodgkin lymphoma (NHL) called follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). FL is a slow-growing type of NHL. DLBCL is a fast-growing type of NHL. NHL is a cancer in the lymphatic system that causes swollen lymph nodes. The lymphatic system is part of the immune system. In this study, researchers want to learn if MK-1045 can treat FL and DLBCL. MK-1045 is a study treatment that is an immunotherapy, which helps the immune system fight cancer. The goals of this study are to learn how safe MK-1045 is and if people tolerate it. Researchers also want to see if FL and DLBCL respond (the cancer gets smaller or goes away) to treatment.
Conditions
- Lymphoma, Non-Hodgkin
- Lymphoma, Follicular
- Lymphoma, Large B-Cell, Diffuse
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: - Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic lines of therapy. - Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). - DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy. - Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care). - Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on CD19-targeting therapy, if experienced disease progression after prior CD19-targeting therapy. - Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if has a history of HIV infection. - Has undetectable hepatitis B virus (HBV) viral load and received and will continue to receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive. - Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviral therapy if has a history of HCV infection. - Has radiographically measurable disease per Lugano Response Criteria.
Exclusion Criteria
The main exclusion criteria include but are not limited to the following: - Has received a solid organ transplant. - Had or has clinically relevant central nervous system (CNS) diseases. - Has a history of serious cardiovascular or cerebrovascular diseases. - Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD); has ongoing evidence of chronic GVHD manifesting as skin involvement, diarrhea, or increased serum bilirubin; or requires systemic immunosuppression for GVHD. - 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 of randomization. - Has received prior CAR-T therapy within 3 months before the first dose of the study intervention. - Has a known additional malignancy that is progressing or required active treatment within the past 2 years. - Has known active CNS lymphoma or involvement. - Has active autoimmune disease that required systemic treatment in the past 2 years. - Has active infection requiring systemic therapy. - Has a history of severe bleeding disorders. - Has not recovered from major surgery or has ongoing surgical complications. - Has diagnosis of primary mediastinal B-cell lymphoma.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1: Follicular Lymphoma (FL) MK-1045 Monotherapy Dose Optimization |
Participants will receive Dosage A of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation. |
|
|
Experimental Arm 2: FL MK-1045 Longer Dosing Interval |
Participants will receive Dosage B of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation. |
|
|
Experimental Arm 3: FL MK-1045 Subcutaneous Administration |
Participants will receive Dosage C of MK-1045 by subcutaneous (SC) injection for up to approximately 1 year of treatment or until discontinuation. |
|
|
Experimental Arm 4: Diffuse Large B-cell Lymphoma (DLBCL) MK-1045 Monotherapy Dose Optimization |
Participants will receive Dosage D of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation. |
|
Recruiting Locations
Nashville, Tennessee 37203
Study Coordinator
844-482-4812
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC