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Study Comparing MK-4280A (Favezelimab and Pembrolizumab) with Chemotherapy for Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer called Classical Hodgkin Lymphoma, specifically in patients whose disease has returned or did not respond to previous treatments. The study is testing a new treatment called MK-4280A, which is a combination of two substances: pembrolizumab and favezelimab. These substances are given as a solution through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The trial will compare the effectiveness of MK-4280A against other chemotherapy treatments chosen by doctors, which may include medications like bendamustine or gemcitabine.

The purpose of the study is to see how well MK-4280A works in treating patients with this type of lymphoma compared to other chemotherapy options. Participants in the study will receive either the new treatment or one of the standard chemotherapy treatments. The study will monitor how the disease responds to the treatment and how long the response lasts. It will also track the overall survival of participants and any side effects they may experience during the study.

This trial is designed to help researchers understand if MK-4280A can provide a better treatment option for patients with Classical Hodgkin Lymphoma that has not responded to other therapies. The study will take place over several months, and participants will be closely monitored by healthcare professionals throughout the process to ensure their safety and to gather important information about the treatment's effectiveness.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide a tumor tissue sample, either from a previous biopsy or a new one, to confirm your diagnosis of classical Hodgkin lymphoma.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either the investigational drug MK-4280A or a chemotherapy treatment chosen by your doctor. The investigational drug is a combination of two substances: pembrolizumab and favezelimab.

  3. Step 3

    Treatment administration

    If you are assigned to the MK-4280A group, you will receive the medication through an intravenous infusion. The frequency and dosage will be determined by the study protocol and your doctor.

    If you are assigned to the chemotherapy group, you may receive either bendamustine or gemcitabine, also through intravenous infusion. The specific medication, dosage, and frequency will be decided by your doctor.

  4. Step 4

    Regular monitoring

    Throughout the trial, you will have regular check-ups to monitor your health and the effects of the treatment. This will include physical exams, blood tests, and imaging studies to assess the progress of your lymphoma.

  5. Step 5

    Response assessment

    Your response to the treatment will be evaluated using specific criteria to determine if the lymphoma is responding to the treatment. This will help in assessing the effectiveness of the investigational drug compared to the chemotherapy.

  6. Step 6

    Completion of treatment

    The duration of your participation in the trial will depend on your response to the treatment and any side effects you may experience. Your doctor will discuss the next steps with you once your participation in the trial is complete.

Who can join the trial?

6 criteria

  • Has a confirmed diagnosis of classical Hodgkin lymphoma (cHL) that shows up on a special type of scan called FDG-avid.
  • Has cHL that has either come back after treatment (relapsed) or has not responded to treatment (refractory), and has tried all available treatments that are known to help.
  • Has had the disease get worse while being treated with a type of medicine called an anti-PD-(L)1 monoclonal antibody (mAb), which could have been given alone or with other treatments.
  • Can provide a sample of the tumor tissue that is either from the last 5 years or newly taken, and this sample should not have been treated with radiation.
  • Is within the age range of 18 years and older.
  • Can be of any gender.

Who cannot join the trial?

5 criteria

  • Patients who have not been diagnosed with Relapsed or Refractory Classical Hodgkin Lymphoma cannot participate. This means the study is only for those whose Hodgkin Lymphoma has returned or did not respond to previous treatment.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is for specific groups of patients.
  • Both male and female patients can participate, but those who do not meet other criteria cannot join.
  • Patients who are considered part of a vulnerable population may not be eligible. This refers to groups who might need special protection in research settings.
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Investigated drugs

  • Favezelimab

    is a medication that is being studied for its potential to help the immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. In this trial, favezelimab is combined with another medication to see if it can help treat a type of cancer called classical Hodgkin lymphoma, especially in patients whose cancer has come back or has not responded to previous treatments.

  • Pembrolizumab

    is a medication that helps the immune system recognize and attack cancer cells. It is already used to treat several types of cancer. In this study, pembrolizumab is combined with favezelimab to see if the combination is more effective in treating classical Hodgkin lymphoma that has returned or is resistant to other treatments. The goal is to see if this combination can improve the chances of stopping or slowing down the cancer.

What is already known about the treatment

MK-4280A – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory classical Hodgkin lymphoma, particularly in patients who have not responded to PD-(L)1 therapies. MK-4280A is a combination of two drugs, favezelimab and pembrolizumab, which work together to help the immune system recognize and attack cancer cells. Favezelimab blocks a protein that can suppress the immune response, while pembrolizumab helps activate immune cells to target cancer. This combination is classified as an immunotherapy, a type of treatment that uses the body's own immune system to fight cancer.

Investigated diseases

Relapsed or Refractory Classical Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting a type of white blood cell called lymphocytes. It is characterized by the presence of Reed-Sternberg cells, which are large, abnormal lymphocytes. The disease is termed "relapsed" when it returns after treatment and "refractory" when it does not respond to initial treatment. As the disease progresses, it can spread to other parts of the lymphatic system, including lymph nodes, spleen, and bone marrow. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing slowly and others more rapidly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503615-14-00Protocol codeMK-4280A-008Estimated enrolment203 patientsSponsorMerck Sharp & Dohme LLC

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).