Study of pembrolizumab with drug combination for first-line treatment in patients with advanced-stage classic Hodgkin lymphoma

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What is this study about?

This clinical trial focuses on treating patients with Advanced Stage Classic Hodgkin Lymphoma, a type of blood cancer affecting the lymphatic system. The study evaluates a new treatment approach combining several medications. The main treatment includes pembrolizumab (marketed as Keytruda), which helps the immune system fight cancer cells, followed by a combination of other anti-cancer medications.

The treatment plan involves multiple medications administered through infusion into a vein or taken orally. These include brentuximab vedotin, dacarbazine, etoposide, doxorubicin, cyclophosphamide, and dexamethasone. The treatment regimen consists of one dose of pembrolizumab followed by four to six cycles of combination therapy. Some patients may also receive radiation therapy as part of their standard care.

The purpose of this study is to determine how well this new treatment combination works in controlling the disease. Doctors will monitor patients’ response to treatment and track their health status for at least one year after starting the therapy. The treatment approach being tested aims to improve outcomes for patients with advanced Hodgkin Lymphoma by combining targeted therapy with traditional chemotherapy medications.

1 Initial treatment with pembrolizumab

You will receive one dose of pembrolizumab (Keytruda) through an intravenous infusion

After this treatment, your response will be evaluated using a PET scan (PET-1)

2 Main treatment phase

You will receive 4-6 cycles of combination therapy called P-BrECADD, which includes:

Pembrolizumab (Keytruda) – intravenous infusion

Brentuximab vedotin (Adcetris) – intravenous infusion

Etoposide – intravenous infusion

Cyclophosphamide – intravenous infusion

Doxorubicin – intravenous infusion

Dacarbazine – intravenous infusion

Dexamethasone – oral medication

3 Treatment monitoring

After 2 cycles of P-BrECADD, you will have another PET scan (PET-3) to check treatment response

Upon completion of all chemotherapy cycles, you will have a final PET scan (PET-5 or PET-7, depending on your treatment duration)

4 Radiotherapy

If needed, you will receive radiotherapy according to standard care guidelines

The need for radiotherapy will be determined based on your PET scan results

5 Follow-up period

Your health status will be monitored for at least one year after treatment completion

Regular assessments will include checking for disease progression and monitoring side effects

You will be asked to complete quality of life questionnaires during this period

Who Can Join the Study?

  • Must have a confirmed first diagnosis of classic Hodgkin Lymphoma (a type of blood cancer affecting lymph nodes)
  • Must have advanced-stage disease with either:
    – Stage IIB with a large chest mass or disease outside lymph nodes, or
    – Stage III-IV disease
  • Must be between 18 and 60 years old
  • Must be willing and able to provide written informed consent
  • Must have adequate blood test results showing:
    – Hemoglobin level of at least 8 g/dL (without recent blood transfusion)
    – White blood cell count of at least 3 x 109/L
    – Platelet count of at least 100 x 109/L (without recent platelet transfusion)
    – Neutrophil count (type of white blood cells) of at least 1.0 x 109/L
  • Must have good physical functioning ability (ECOG score of 0 or 1, meaning able to perform daily activities with minimal assistance)
  • Must have a life expectancy greater than 3 months
  • For women who can become pregnant:
    – Must not be pregnant or breastfeeding
    – Must agree to use effective contraception during the study and for 6 months after
  • For men:
    – Must agree to use contraception during the study and for 6 months after
    – Must not donate sperm during this period

Who Cannot Join the Study?

  • Age below 18 years old or above 60 years old
  • Previous treatment for Hodgkin Lymphoma (a type of blood cancer affecting white blood cells)
  • Presence of active infections
  • Pregnancy or breastfeeding
  • History of another type of cancer in the past 5 years
  • Severe heart conditions or uncontrolled heart disease
  • Severe liver problems
  • Severe kidney problems
  • Active autoimmune disease (where the body’s immune system attacks healthy cells)
  • Known allergy or sensitivity to any of the study medications
  • Mental conditions that could interfere with following study procedures
  • Participation in another clinical trial within the last 30 days
  • Use of medications that could interfere with the study treatment
  • HIV (Human Immunodeficiency Virus) infection
  • Active hepatitis B or C infection (viral infections affecting the liver)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsmedizin Goettingen Goettingen Germany

Other Sites

Site Name City Country Status
Gesundheit Nord gGmbH Klinikverbund Bremen Bremen Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Ugdsyubobc Mvynsbw Cxrvkc Hysrpoygbawcxeceb Hamburg Germany
Ulttuhvncfplrfpearews Ewdog Aei Essen Germany
Usbzaeibtu Hajchkjr Cbznxoh Cologne Germany
Gsjqhm Udyyvjisof Fuodusspf Frankfurt Germany
Kfaleimy dtb Ujzosrwhlfau Mktmpbfg Azm Munich Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.12.2025

Trial locations

Pembrolizumab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-1, which normally prevents T-cells (immune cells) from attacking cancer cells. By blocking this protein, pembrolizumab allows your immune system to better recognize and destroy cancer cells, particularly in Hodgkin Lymphoma.

P-BrECADD is a combination chemotherapy regimen that contains multiple medications working together to treat Hodgkin Lymphoma. This treatment combines different drugs that attack cancer cells in various ways to make the treatment more effective. It is administered through intravenous infusion in cycles.

Note: The treatment plan also includes radiotherapy as a standard part of care, which uses targeted radiation to destroy cancer cells in specific areas of the body.

Classic Hodgkin Lymphoma – A type of blood cancer that begins in the lymphatic system, specifically affecting a type of white blood cells called lymphocytes. The disease typically starts in the lymph nodes and can spread progressively through the lymphatic system to other parts of the body. It is characterized by the presence of abnormal cells called Reed-Sternberg cells, which are much larger than normal lymphocytes. The condition usually develops in a predictable pattern, moving from one group of lymph nodes to another. In advanced stages, it can spread to organs outside the lymphatic system.

Trial ID:
2022-501458-13-01
Protocol code:
Uni-Koeln-4938
NCT ID:
NCT06045159
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A Study of Pembrolizumab and Radiotherapy for Patients with Early-Stage Favorable Classic Hodgkin Lymphoma

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  • Study of Nivolumab for Early Stage Hodgkin Lymphoma in Patients with Good Prognosis

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