A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)

A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK-1045 Monotherapy or in Combination With Other Anticancer Agents in Participants With Non-Hodgkin Lymphoma

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.

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.