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

200 patients around the world

Available in Argentina

Merck Sharp & Dohme LLC

1Research sites

200Patients around the world

This study is for people with

Lymphoma

Non-Hodgkin lymphoma

Non-Hodgkin Lymphoma

Follicular lymphoma

Diffuse large B-cell lymphoma

From 18 Years

All Gender

: 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.

: 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.

Sanatorio Nuestra Señora del Rosario

Recruiting

Sarmiento 3125, Rosario, Santa Fe

SponsorMerck Sharp & Dohme LLC

Study typeInterventional

Conditions

Non-Hodgkin lymphomaFollicular lymphomaDiffuse large B-cell lymphoma

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07519772