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Study of Pembrolizumab with Hyaluronidase for Patients with Relapsed or Refractory Hodgkin Lymphoma or Primary Mediastinal Large B-cell Lymphoma

Verified siteInvestigationalNo placebo
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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 two types of blood cancers: Relapsed or Refractory Classical Hodgkin Lymphoma and Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma. These are conditions where the cancer has returned or has not responded to previous treatments. The study will use a treatment called MK-3475A, which is a solution for injection containing the active substance Pembrolizumab. Pembrolizumab is a type of protein that helps the immune system fight cancer cells. In this study, it is combined with another substance called hyaluronidase to help it be absorbed when injected under the skin.

The purpose of the study is to understand how the body processes Pembrolizumab when given as a subcutaneous injection and to evaluate its effectiveness and safety in treating these cancers. Participants will receive the treatment in cycles, and researchers will monitor how the drug is absorbed and how well it works in reducing cancer symptoms. The study will also look at the overall response of the cancer to the treatment, as well as any side effects that may occur.

Throughout the study, participants will undergo regular assessments to track their response to the treatment and any changes in their condition. The study aims to provide valuable information on the potential benefits and risks of using Pembrolizumab in this new form of administration for patients with these specific types of lymphoma.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of either classical Hodgkin lymphoma or primary mediastinal B-cell lymphoma.

    Additional criteria include having a measurable disease, a life expectancy of at least three months, and a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of pembrolizumab, which is provided as a solution for injection under the skin (subcutaneous).

    The first cycle of treatment is designed to evaluate the pharmacokinetics, which is how the drug moves through the body.

  3. Step 3

    Cycle 1 evaluation

    During Cycle 1, the focus is on measuring the maximum plasma concentration, trough concentration, and the area under the curve of pembrolizumab.

    These measurements help in understanding the drug's behavior in the body after the initial dose.

  4. Step 4

    Subsequent cycles

    In subsequent cycles, particularly Cycle 3, the study continues to monitor the drug's concentration at steady state.

    The study also assesses the presence of any anti-drug antibodies and records any adverse events experienced by participants.

  5. Step 5

    Response assessment

    The objective response rate is evaluated according to the Lugano classification criteria, which helps in determining the effectiveness of the treatment.

    The duration of response is also assessed to understand how long the treatment benefits last.

  6. Step 6

    Completion and follow-up

    The study is estimated to conclude by November 2028, with follow-up assessments to monitor long-term outcomes and any late-onset side effects.

    Participants are observed for any discontinuation of treatment due to adverse events.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of either **classical Hodgkin lymphoma (cHL)** or **primary mediastinal B-cell lymphoma (PMBCL)**. These are specific types of blood cancer.
  • The disease must be measurable using imaging tests, as assessed by a doctor following specific guidelines called the **Lugano classification**.
  • Must have a life expectancy of at least 3 months.
  • If the participant is infected with **HIV**, the virus that causes AIDS, it must be well controlled with medication.
  • If the participant has **hepatitis B**, a liver infection, they must have been on antiviral medication for at least 4 weeks and have no detectable virus in their blood before starting the study.
  • If the participant has had **hepatitis C**, another liver infection, they must have completed treatment at least 4 weeks before starting the study and have no detectable virus in their blood at the time of screening.
  • Must have an **ECOG performance status** of 0 to 1, which means they are fully active or have some symptoms but do not need to stay in bed. This is assessed within 7 days before the first dose of the study treatment.
  • Both male and female participants are eligible.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not the specific types being studied cannot participate.
  • Patients who have had a severe allergic reaction to similar treatments in the past are not eligible.
  • Patients with active infections that require treatment with antibiotics or other medications cannot join the study.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients with certain heart conditions that are not stable are excluded from the study.
  • Patients who have received another experimental treatment within a certain time frame before the study starts cannot participate.
  • Patients with a history of certain autoimmune diseases, which are conditions where the body's immune system attacks its own tissues, are not eligible.
  • Patients who have had a major surgery within a specific period before the study begins are excluded.
  • Patients with uncontrolled high blood pressure are not allowed to join the study.
  • Patients with a history of drug or alcohol abuse that could interfere with the study are not eligible.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this study to treat certain types of lymphoma, specifically relapsed or refractory classical Hodgkin lymphoma and relapsed or refractory primary mediastinal large B-cell lymphoma. It works by helping the immune system recognize and attack cancer cells more effectively. In this trial, pembrolizumab is given as a subcutaneous injection, which means it is injected under the skin. The study aims to understand how the body processes this medication and to evaluate its effectiveness and safety for patients with these types of lymphoma.

  • Hyaluronidase

    is combined with pembrolizumab in this study to help improve the absorption of the medication when it is injected under the skin. Hyaluronidase is an enzyme that temporarily breaks down a substance in the body called hyaluronic acid, which can help the medication spread more easily and be absorbed more effectively. This combination is being tested to see if it can enhance the delivery and effectiveness of pembrolizumab in treating lymphoma.

What is already known about the treatment

Pembrolizumab – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating relapsed or refractory classical Hodgkin's lymphoma and relapsed or refractory primary mediastinal large B-cell lymphoma. Pembrolizumab works by blocking a specific protein on immune cells, which helps the immune system attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that enhances the body's immune response against cancer.

Investigated diseases

  • Relapsed or Refractory Classical Hodgkin's 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. The disease is termed "relapsed" when it returns after treatment and "refractory" when it does not respond to initial treatment. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression can vary, with some cases advancing slowly while others may progress more rapidly.

  • Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma

    This is a subtype of non-Hodgkin lymphoma that primarily affects the mediastinum, the area in the chest between the lungs. It involves large B-cells, a type of white blood cell, and is considered aggressive. The term "relapsed" indicates the disease has returned after treatment, while "refractory" means it did not respond to initial therapy. Symptoms often include chest pain, cough, and difficulty breathing due to the mass in the chest. The disease can progress quickly, requiring close monitoring and management.

Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510969-42-00Protocol codeMK-3475A-F65Estimated enrolment82 patientsSponsorMerck Sharp & Dohme LLC

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