A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07634471
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • MK-1045 — BIOLOGICAL
    Intravenous (IV) infusion
  • Rituximab — BIOLOGICAL
    IV infusion
  • Rituximab biosimilar — BIOLOGICAL
    IV infusion
  • Bendamustine — DRUG
    IV infusion
  • Cyclophosphamide — DRUG
    IV infusion
  • Vincristine — DRUG
    IV infusion
  • Prednisone — DRUG
    Per approved product label
  • Prednisolone — DRUG
    Per approved product label
  • Doxorubicin Hydrochloride — DRUG
    IV infusion

Study Details

Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy. The goals of this study are to learn: * About the safety of MK-1045 and rituximab, and if people tolerate them when given together * If people who receive MK-1045 and rituximab have the cancer go away * If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)

Key Dates

Start date
Jul 6, 2026
Status verified
Jun 2026
Primary completion
Jul 23, 2032
Completion
Jul 23, 2035

Study Design

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

Arms

  • Experimental: Part 1: MK-1045 plus Rituximab (or biosimilar)
    Participants will receive escalating doses of MK-1045 (from 2 mg to 90 mg) once weekly (QW) for up to approximately 12 months. Participants will also receive 375 mg/m\^2 rituximab (or biosimilar) once every 4 weeks (Q4W) for up to approximately 6 months.
  • Experimental: Part 2: MK-1045 plus Rituximab (or biosimilar)
    Participants will receive MK-1045 QW at the dose determined in Part 1 for up to approximately 12 months. Participants will also receive 375 mg/m\^2 rituximab (or biosimilar) Q4W for up to approximately 6 months.
  • Experimental: Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)
    Participants will receive physician's choice of: 90 mg/m\^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m\^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 1.4 mg/m\^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m\^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m\^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m\^2 cyclophosphamide and 1.4 mg/m\^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m\^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.

Primary Outcome Measure

Part 1: Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 15 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SCRI Oncology Partners ( Site 7000)NashvilleTennessee37203
Study Coordinator
615-329-7640

Find similar trials in Nashville, TN

By research site
SCRI Oncology Partners· Nashville, TN

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