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

Studio Clinico

Patologia: Linfomi

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: 1, I B, II

Linee di trattamento: Terza/N linea

Criteri di inclusione: 

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.

Criteri di esclusione: 

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.

Trattamento sperimentale: 

MK-1045

Trattamento di controllo: 

-

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2025-523005-15-00

Data di inserimento: 01.10.2026

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: na