Actively Recruiting
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
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-15
200
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of MK-1045 in people with two types of non-Hodgkin lymphoma (NHL): follicular lymphoma (FL), which grows slowly, and diffuse large B-cell lymphoma (DLBCL), which grows quickly. NHL is a cancer affecting the lymphatic system, causing swollen lymph nodes. This study aims to see if MK-1045, an immunotherapy that helps the immune system fight cancer, is safe and tolerated, and whether it can reduce or eliminate these lymphomas. Participants will be randomly assigned to one of four groups. Each group will receive MK-1045 at different dosages and by different methods: intravenous (IV) infusion or subcutaneous (SC) injection. Treatment will last for up to about one year or until the participant stops treatment. The study includes groups focusing on FL with dose optimization or longer dosing intervals, one group receiving SC administration, and one group focusing on DLBCL with dose optimization. During the study, researchers will monitor participants for adverse events and treatment effects using the Lugano Response Criteria. They will also measure drug levels in the blood at various times up to 12 months. Participants will be followed for up to approximately 44 months to assess safety, response duration, and treatment tolerability. Tumor tissue samples and other clinical data will be collected to support these evaluations throughout the trial.
CONDITIONS
Brief Title
A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) after at least 2 prior systemic treatments
- DLBCL participants only: progressed after or ineligible for transplant and CAR-T therapy
- Histologically confirmed diagnosis of FL or DLBCL
- Provided tumor tissue sample (archival or newly obtained)
- Documented retained CD19 expression in tumor tissue if progressed after CD19-targeting therapy
- Well-controlled HIV on antiretroviral therapy if HIV positive
- Undetectable HBV viral load and receiving HBV antiviral therapy if HBsAg-positive
- Undetectable HCV viral load and received HCV antiviral therapy if history of HCV infection
- Radiographically measurable disease per Lugano Response Criteria
You will not qualify if you...
- Received a solid organ transplant
- Has clinically relevant central nervous system (CNS) diseases
- History of serious cardiovascular or cerebrovascular diseases
- Prior allogenic stem cell transplantation with acute graft-versus-host disease (GVHD) or ongoing chronic GVHD requiring systemic immunosuppression
- HIV-infected with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Received live or live-attenuated vaccine within 30 days before randomization
- Prior CAR-T therapy within 3 months before first study dose
- Additional malignancy progressing or treated within past 2 years
- Known active CNS lymphoma or involvement
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active infection requiring systemic therapy
- History of severe bleeding disorders
- Not recovered from major surgery or has ongoing surgical complications
- Diagnosis of primary mediastinal B-cell lymphoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 1 year or until discontinuation
Participants receive MK-1045 by intravenous infusion or subcutaneous injection as monotherapy or in combination with other anticancer agents for up to approximately 1 year or until discontinuation.
Trial Site Locations
Total: 1 location
1
Haddasah Medical Center ( Site 0600)
Jerusalem, Israel, 9112001
Actively Recruiting
Research Team
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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