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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 trial about?

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

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.

The research process

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

Step 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)
Step 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
Step 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)
Step 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
Step 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 trial?

9 criteria

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 trial?

15 criteria

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)

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Goethe University Frankfurt
Frankfurt, Germany
Responsive
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Stuttgart, Germany

Trial locations

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Investigated drugs

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.

What is already known about the treatment

Pembrolizumab
A prescription medication administered through intravenous infusion that belongs to the class of immunotherapy drugs known as PD-1 inhibitors. This monoclonal antibody works by helping the immune system detect and fight cancer cells by blocking the PD-1 pathway, which cancer cells often use to hide from immune cells. It is primarily used in the treatment of various cancers, including advanced Hodgkin lymphoma, and has shown significant effectiveness in clinical trials, particularly as a first-line treatment option. The medication is typically given every three weeks as part of a planned treatment schedule, often in combination with other cancer therapies.
BrECADD
A combination chemotherapy regimen that includes multiple anti-cancer medications administered intravenously in cycles. This protocol is specifically designed for treating classical Hodgkin lymphoma and consists of brentuximab vedotin combined with etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone. The regimen works through multiple mechanisms to target cancer cells, including DNA damage, cell death induction, and targeted therapy against CD30-positive lymphoma cells. It represents a modified version of standard chemotherapy protocols, aiming to improve efficacy while maintaining a manageable side effect profile.

Investigated diseases

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.