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Study of Pembrolizumab with Chemotherapy for Patients with Relapsed or Refractory Classical Hodgkin 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

This clinical trial is focused on studying a type of blood cancer called classical Hodgkin lymphoma, specifically in patients who have experienced a first relapse or whose disease did not respond to initial treatment. The study is testing a new combination of treatments to see if it can effectively manage this condition. The main treatment being tested is pembrolizumab, also known by its code name MK-3475, which is an anti-PD-1 antibody. This is being combined with established chemotherapy regimens, including ifosfamide, cisplatin, carboplatin, etoposide phosphate, cytarabine, and dexamethasone. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of this study is to develop a treatment plan that is both effective and easy for patients to tolerate. Participants in the trial will receive a combination of pembrolizumab and chemotherapy over several cycles. The study will monitor how well the cancer responds to this treatment and will also look at the overall health and quality of life of the participants. Some patients may receive additional treatments like high-dose chemotherapy and a procedure called autologous stem cell transplantation, which involves using the patient's own stem cells to help recover from the effects of chemotherapy.

The trial will also track the long-term outcomes of the participants, such as how long they remain free from cancer progression and their overall survival rates. Additionally, the study will collect information on any side effects experienced by the participants and how these affect their daily lives. The goal is to find a treatment that not only works well but also maintains a good quality of life for those involved.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and initial assessment

    Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes a review of your medical history, a physical examination, and necessary tests to ensure you meet the study criteria.

    You will be required to provide written informed consent, confirming your understanding and agreement to participate in the trial.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of pembrolizumab through an intravenous infusion. This is a type of medication that helps your immune system fight cancer cells.

    Following the initial dose of pembrolizumab, you will receive a combination of chemotherapy drugs, which may include ifosfamide, cisplatin, carboplatin, etoposide phosphate, and cytarabine. These are also given through intravenous infusion.

  3. Step 3

    Combination therapy cycles

    You will undergo four cycles of combination therapy. This involves receiving pembrolizumab along with chemotherapy drugs. The specific regimen may vary, with options including 4 cycles of P-ICE (pembrolizumab, ifosfamide, carboplatin, etoposide) or 2 cycles of P-ICE followed by 2 cycles of P-DHAP (pembrolizumab, dexamethasone, cytarabine, cisplatin).

    Each cycle will be followed by a period of rest to allow your body to recover before the next cycle begins.

  4. Step 4

    Restaging and evaluation

    After completing the treatment cycles, you will undergo restaging to evaluate the response to the therapy. This involves imaging tests to assess the size and activity of the cancer.

    The goal is to achieve a complete metabolic response, which means the cancer shows no signs of activity on the scans.

  5. Step 5

    Follow-up and additional treatment

    Depending on the response to the initial treatment, you may receive additional therapy, such as high-dose chemotherapy and autologous stem cell transplantation, to further improve outcomes.

    Regular follow-up visits will be scheduled to monitor your health, manage any side effects, and assess long-term outcomes such as progression-free survival and overall survival.

Who can join the trial?

9 criteria

  • Histologically confirmed first relapse or primary refractory classical Hodgkin lymphoma (cHL). This means that a doctor has confirmed through a tissue sample that the disease has returned or did not respond to initial treatment.
  • No previous treatment for relapsed or refractory Hodgkin lymphoma (r/r HL).
  • Age between 18 and 65 years.
  • Patient has given written informed consent to participate in the trial. This means the patient has agreed in writing to join the study after being informed about it.
  • Estimated life expectancy of more than 3 months.
  • For women: a negative pregnancy test is required.
  • Presence of measurable disease. This means there are tumors or lesions that can be measured. If these are in an area that was previously treated with radiation, they must show signs of growth to be considered measurable.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but nearly fully active. This evaluation must be done within 7 days before joining the study.
  • Patient is considered eligible for autologous stem cell transplantation by the investigator. This means the patient can potentially undergo a procedure where their own stem cells are used to replace damaged or destroyed bone marrow.

Who cannot join the trial?

1 criterion

  • Patients who have not experienced a first relapse or are not primary refractory to classical Hodgkin lymphoma. (A first relapse means the disease has returned after treatment. Primary refractory means the disease did not respond to initial treatment.)
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Investigated drugs

  • Pembrolizumab

    is a type of medication known as an anti-PD-1 antibody. It works by helping your immune system recognize and attack cancer cells. In this trial, pembrolizumab is being tested in combination with other treatments to see if it can help treat a type of cancer called classical Hodgkin lymphoma that has come back or has not responded to previous treatments.

  • ICE Chemotherapy

    is a combination of three chemotherapy drugs used to treat certain types of cancer. It includes ifosfamide, carboplatin, and etoposide. These drugs work together to kill cancer cells or stop them from growing. In this trial, ICE chemotherapy is being used alongside pembrolizumab to see if the combination is more effective in treating classical Hodgkin lymphoma.

  • DHAP Chemotherapy

    is another combination of chemotherapy drugs used to treat cancer. It includes dexamethasone, high-dose cytarabine, and cisplatin. These drugs work by attacking cancer cells and preventing them from multiplying. In this trial, DHAP chemotherapy is combined with pembrolizumab to test if this combination can better treat classical Hodgkin lymphoma that has returned or is resistant to other treatments.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating classical Hodgkin lymphoma that has either returned after initial treatment or did not respond to initial treatment. The main therapeutic use of pembrolizumab in this context is to help the immune system recognize and attack cancer cells. At the molecular level, pembrolizumab works by blocking a specific protein called PD-1 on immune cells, which can help the immune system to better detect and destroy cancer cells. It is classified as an anti-PD-1 antibody, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Classical Hodgkin Lymphoma – Classical Hodgkin Lymphoma is a type of cancer that originates in the lymphatic system, which is part of the immune system. It is characterized by the presence of Reed-Sternberg cells, a specific type of abnormal cell. The disease typically begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, bone marrow, and lungs. As the disease progresses, it may cause symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression can vary, with some cases remaining localized while others spread more extensively. The disease is often identified in its early stages due to noticeable symptoms, allowing for timely intervention.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501306-35-00Protocol codeUni-Koeln-3942Estimated enrolment29 patientsSponsorUniversity Of Cologne

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