MK-1045 for Follicular Lymphoma and Diffuse Large B-Cell Lymphoma
Tests the immunotherapy MK-1045 in adults with two types of non-Hodgkin lymphoma.
Plain-language title generated from the registry record
Registry title: A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
Key facts
- Where
- Badalona, Barcelona, Madrid, and Málaga, SpainSee the 5 sites
- Phase
- Phase 1/2
Where in Spain
- Institut Catala d'OncologiaBadalona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07519772EU 2025-523005-15-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
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: 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: Has received a solid organ transplant; 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 not recovered from major surgery or has ongoing surgical complications; Had or has clinically relevant central nervous system (CNS) diseases; Has a history of serious cardiovascular or cerebrovascular diseases; Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease; Has a known additional malignancy that is progressing or required active treatment within the past 2 years; 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; 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; The main exclusion criteria include but are not limited to the following:; Has known active CNS lymphoma or involvement; Has diagnosis of primary mediastinal B-cell lymphoma.