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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07519772
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-1045 — BIOLOGICAL
    Intravenous (IV) Infusion or Subcutaneous (SC) injection

Study Details

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.

Key Dates

First listed
Apr 9, 2026
Start date
May 3, 2026
Status verified
Jul 2026
Primary completion
Jul 1, 2030
Completion
Apr 1, 2031

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Follicular Lymphoma (FL) MK-1045 Monotherapy Dose Optimization
    Participants will receive Dosage A of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.
  • Experimental: Arm 2: FL MK-1045 Longer Dosing Interval
    Participants will receive Dosage B of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.
  • Experimental: Arm 3: FL MK-1045 Subcutaneous Administration
    Participants will receive Dosage C of MK-1045 by subcutaneous (SC) injection for up to approximately 1 year of treatment or until discontinuation.
  • Experimental: Arm 4: Diffuse Large B-cell Lymphoma (DLBCL) MK-1045 Monotherapy Dose Optimization
    Participants will receive Dosage D of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.

Primary Outcome Measure

Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 44 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SCRI Oncology Partners ( Site 0100)NashvilleTennessee37203
Study Coordinator
844-482-4812

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