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Study of MK-1045 plus rituximab in patients with newly diagnosed follicular lymphoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Follicular Lymphoma, a slow‑growing cancer that starts in the lymph nodes and can spread to other parts of the blood‑forming system. The experimental treatment combines a new drug called MK-1045 with rituximab, a medication that helps the immune system recognize and destroy cancer cells. Both medicines are given by intravenous infusion, which means they are delivered directly into a vein through a short needle.

The purpose is to determine whether the combination is safe and works better than the usual chemotherapy plus rituximab. Safety is evaluated by recording any adverse events (unwanted medical problems) and any dose‑limiting toxicity (a side effect that prevents increasing the dose). Effectiveness is judged by the rate of complete response, meaning all detectable cancer disappears, and by PFS, the length of time a person lives without the disease getting worse.

Participants receive the study medicines in repeated cycles that last a few weeks, with regular clinic visits for blood tests, imaging scans, and overall health checks. After the treatment period, they are followed for several years to watch for any return of the cancer and to continue safety monitoring. All data are collected confidentially and in accordance with standard clinical‑trial procedures.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and study entry

    After providing informed consent, a study identification number is assigned and the patient becomes a participant in the trial.

    Initial documentation of personal health information and medical history is completed.

  2. Step 2

    Baseline assessments

    A physical examination, laboratory tests, and imaging studies are performed to establish the starting condition of the disease.

    The results are used to confirm eligibility for the trial and to serve as reference points for later comparisons.

  3. Step 3

    Start of part 1 treatment

    The patient receives an intravenous infusion of mk-1045. the specific dose is not provided in the available information.

    Immediately following or combined with mk-1045, an intravenous infusion of rituximab is administered. the dose and concentration are listed as 00 % (v/v) in the source data, but exact milligram amounts are not specified.

    Both infusions are given according to the study schedule; the frequency and total duration are defined by the trial protocol.

  4. Step 4

    Safety monitoring during part 1

    The patient is observed for any adverse events, including dose‑limiting toxicities, during and after each infusion.

    If a serious adverse event occurs, the study medication may be discontinued according to the protocol.

  5. Step 5

    Response evaluation after part 1

    The treating physician assesses the disease response using the lugano criteria to determine a complete response (cr).

    Additional measurements such as objective response rate and duration of response are recorded.

  6. Step 6

    Transition to part 2

    Based on the study design, the patient is randomized to either continue receiving mk-1045 with rituximab or to receive the physician’s choice chemotherapy combined with rituximab.

    The assignment is made by the study investigators and follows the predefined randomization scheme.

  7. Step 7

    Continuation of mk-1045 plus rituximab (test arm)

    If assigned to the test arm, the patient continues to receive intravenous infusions of mk-1045 and rituximab on the same schedule used in part 1.

    Ongoing safety checks and disease assessments are performed throughout the treatment period.

  8. Step 8

    Chemotherapy plus rituximab (comparator arm)

    If assigned to the comparator arm, the patient receives a combination of chemotherapy agents administered intravenously:

    cyclophosphamide 750 mg/m², doxorubicin 50 mg/m², bendamustine 90 mg/m², and vincristine 1.4 mg/m².

    In addition, oral prednisone (or prednisolone) is taken at a dose of 40 mg/m² per day.

    The frequency of each medication follows the chemotherapy cycle schedule defined by the protocol.

  9. Step 8

    Ongoing monitoring and follow‑up

    Regular clinic visits are scheduled for physical examinations, laboratory testing, and imaging to monitor disease status.

    Key outcomes such as progression‑free survival, overall survival, and quality‑of‑life questionnaires are collected according to the trial timeline.

  10. Step 9

    Final study assessment

    At the end of the study period, a comprehensive evaluation is performed to record final response rates, survival data, and any lasting adverse events.

    All study data are compiled for analysis of the primary and secondary endpoints.

Who can join the trial?

6 criteria

  • Must have a diagnosis of follicular lymphoma that was confirmed by a tissue sample (a biopsy) and has not been treated before; the cancer cells must show the markers CD19 and CD20 (these are proteins on the cell surface that doctors test for).
  • Must have disease that can be seen and measured on imaging scans (such as CT or PET scans) using the Lugano Response Criteria (a set of rules doctors use to size and track tumors).
  • Must provide a recent tissue sample—either a small needle‑taken sample (core biopsy) or a larger piece removed surgically (excisional biopsy)—or give stored tissue from a previous test, and the tumor area must not have been treated with radiation before.
  • If you are HIV positive, the virus must be well‑controlled with medicines called antiretroviral therapy (ART) (drugs that keep the virus at low levels).
  • If you test positive for hepatitis B surface antigen (HBsAg), you must have an undetectable amount of hepatitis B virus (HBV) viral load in your blood and must have been taking hepatitis B antiviral medicine for at least four weeks and continue taking it.
  • If you have a history of hepatitis C virus (HCV) infection, the amount of virus in your blood must be undetectable (no measurable virus).

Who cannot join the trial?

14 criteria

  • Has already received chemotherapy (medicine that travels through the whole body) or radiation treatment for follicular lymphoma.
  • Has a known active brain or spinal‑cord lymphoma, or the disease has spread to these areas.
  • Has an active autoimmune disease (a condition where the immune system attacks the body) that needed medicine affecting the whole body within the last 2 years.
  • Has an active infection that requires medicine that works throughout the body.
  • Has chronic liver disease, including liver scarring (cirrhosis) that is moderate to severe (called Child‑Pugh class B or C).
  • Has not fully recovered from a major operation or still has problems from surgery.
  • Has a type of lymphoma called follicular large B‑cell lymphoma or any other subtype that is not the usual (classical) follicular lymphoma.
  • Has follicular lymphoma that has changed into a faster‑growing, more aggressive form of lymphoma.
  • Has a history of, or currently has, important brain or spinal‑cord (central nervous system) diseases.
  • Has a history of serious heart problems (cardiovascular disease) or serious blood‑vessel problems in the brain (cerebrovascular disease).
  • Is infected with HIV and has a history of Kaposi’s sarcoma (a type of cancer) and/or Multicentric Castleman’s Disease (a rare lymph node disorder).
  • Received a live or weakened‑live vaccine within 30 days before the first study dose.
  • Has a diagnosed weak immune system (immunodeficiency) or is taking long‑term steroids that affect the whole body.
  • Has another cancer that is getting worse or needed active treatment within the past 3 years.
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Investigated drugs

  • MK-1045

    is an experimental drug that is being tested for the first time in this study. It is given through an IV (intravenous) infusion and is combined with another medication, rituximab, to see if the combination can treat follicular lymphoma safely and effectively.

  • Rituximab

    is a well‑known antibody that targets a protein called CD20 on certain white blood cells. By binding to these cells, it helps the immune system destroy cancer cells. In this trial rituximab is given by IV infusion and is used together with MK‑1045 or with standard chemotherapy, depending on the study arm.

  • Tocilizumab

    is a medication that blocks a molecule called interleukin‑6, which can reduce inflammation and may affect the immune response. In this study it is listed as a background therapy, meaning it is allowed for patients who need it but is not the main focus of the trial.

  • Cyclophosphamide

    is a chemotherapy drug that works by stopping cancer cells from dividing. It is given by IV infusion and is part of the physician’s choice chemotherapy regimen that is compared with the MK‑1045 + rituximab combination.

  • Doxorubicin

    is another chemotherapy agent that interferes with the DNA of cancer cells, leading to their death. It is administered intravenously and is included in the standard chemotherapy regimen used as a comparator in the study.

  • Bendamustine

    is a chemotherapy drug that both damages DNA and affects the cell’s ability to repair it. It is given by IV infusion and is part of the chemotherapy options that patients may receive instead of the experimental treatment.

What is already known about the treatment

  • Rituximab

    Rituximab is given by intravenous infusion, where the drug is slowly injected into a vein. It is an approved medicine used for treating certain blood cancers, including follicular lymphoma. The drug works by attaching to a protein called CD20 on B‑cells and signaling the immune system to destroy these cells. It belongs to the class of monoclonal antibodies.

  • Tocilizumab

    Tocilizumab is administered by injection, usually into a vein or under the skin. It is an approved drug for inflammatory conditions such as rheumatoid arthritis and for some severe COVID‑19 cases. It blocks the activity of a molecule called interleukin‑6, reducing inflammation. It is classified as an interleukin‑6 receptor antagonist.

  • Cyclophosphamide

    Cyclophosphamide is given as an intravenous infusion. It is a long‑used chemotherapy drug for many cancers, including lymphomas. The medication works by damaging the DNA of rapidly dividing cells, which stops their growth. It is classified as an alkylating agent.

  • Doxorubicin

    Doxorubicin is delivered by intravenous infusion. It is an established chemotherapy used for a wide range of cancers, such as lymphomas and breast cancer. It interferes with the DNA inside cancer cells, preventing them from multiplying. It belongs to the anthracycline class of antibiotics.

  • Prednisolone

    Prednisolone is taken orally as a tablet or liquid. It is a widely used steroid for reducing inflammation and suppressing the immune system in many conditions, including cancer‑related swelling. The drug works by mimicking natural hormones that calm down immune responses. It is classified as a glucocorticoid.

  • Bendamustine

    Bendamustine is administered by intravenous infusion. It is an approved chemotherapy for chronic lymphocytic leukemia and some non‑Hodgkin lymphomas. The drug combines alkylating activity with a break in DNA, leading to cancer cell death. It is categorized as an alkylating agent.

Investigated diseases

Follicular Lymphoma - Follicular lymphoma is a cancer that begins in certain white‑blood cells called B‑cells, usually inside lymph nodes. It grows slowly and forms clusters of abnormal cells in the lymph nodes, spleen, and bone marrow. Over time the disease can spread to other parts of the lymphatic system. The condition often remains stable for months or years before it changes in appearance or extent.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-522777-10-00Protocol codeMK-1045-007Estimated enrolment52 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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