Not yet recruitingPHASE2INTERVENTIONAL

Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma

This study is exploring a new treatment approach for advanced Hodgkin Lymphoma, a type of blood cancer. It involves giving patients a single dose of a drug called pembrolizumab, followed by several cycles of standard chemotherapy, and then targeted radiotherapy if needed. Pembrolizumab works by helping your body's immune system fight the cancer. The main goal is to find out how effective this new combination therapy is at preventing the cancer from coming back within a year. Researchers want to understand if this new treatment can offer a better outcome for people newly diagnosed with advanced Hodgkin Lymphoma, ultimately hoping to improve their long-term health.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

University of Cologne

Enrolment target

Start

01 Aug 2025

Estimated completion

01 Jan 2029

Hodgkin Lymphoma

What is this study about?

This study is looking into a new way to treat advanced Hodgkin Lymphoma, which is a type of cancer that affects your lymphatic system, part of your body's immune system. When doctors say 'advanced stage', it means the cancer has spread to several areas.

The research is testing a new treatment plan that starts with a single dose of a drug called pembrolizumab. Pembrolizumab is a type of immunotherapy that helps your own immune system to recognise and fight cancer cells. After this initial dose, patients will receive a standard type of chemotherapy, which is a powerful medicine used to kill cancer cells, for about four to six cycles. If necessary, patients might also have radiotherapy, which uses high-energy rays to destroy cancer cells, just like people usually would in standard care.

The main aim of this study is to see how effective this new combination of treatments is. Specifically, doctors want to find out how many patients are still free from their cancer one year after starting treatment. This will help them understand if this new approach could be a better option for people who have just been diagnosed with advanced Hodgkin Lymphoma.

Key takeaways

This study is for advanced classical Hodgkin Lymphoma.
It uses a new drug, pembrolizumab, with standard chemotherapy and potentially radiotherapy.
The main goal is to see if this new treatment stops the cancer from returning.
It's a Phase 2 trial, focusing on treatment effectiveness and safety.
Participants must be 18-60 years old and new to treatment for this condition.

Who may be eligible?

To join this study, participants need to be between 18 and 60 years old and have been diagnosed with an advanced form of classical Hodgkin Lymphoma. It's important that you haven't had any treatment for this specific type of lymphoma before.

There are also some reasons why you might not be able to join. For example, if you have a different type of Hodgkin Lymphoma called Nodular lymphocyte-predominant, or if you've had a mixture of different lymphoma types, this study isn't for you. Also, if you've had chemotherapy or radiotherapy in the past, or if you have any other serious health conditions that would make it difficult or unsafe to follow the study's treatment plan, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 60 years old?
Have you been diagnosed with advanced classical Hodgkin Lymphoma?
Have you *not* had any treatment for Hodgkin Lymphoma before?
Do you *not* have other serious medical conditions that would prevent study participation?
Has a doctor confirmed your type of Hodgkin Lymphoma is 'classical' and not Nodular lymphocyte-predominant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first receive a single dose of the drug pembrolizumab. After this, you will have several cycles (usually four to six) of a standard chemotherapy treatment. Some participants may also need to have PET-guided radiotherapy, which is a targeted form of radiation therapy. You will have regular check-ups and scans to see how you are responding to the treatment and to monitor your health. The duration of actual treatment phases varies, but the study will monitor your progress to see how well the new treatment works over at least one year.

Potential risks and benefits

Taking part in a study like this might offer the potential benefit of trying a new treatment approach that could be more effective than standard treatments alone for Hodgkin Lymphoma. However, like all medicines, pembrolizumab and chemotherapy can have side effects, which your doctors will discuss with you. There might be unknown risks associated with new treatments. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

1st Department of Medicine, Cologne University Hospital
Verified postcode
Cologne, Germany

Common questions

What is Hodgkin Lymphoma?

Hodgkin Lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system.

What is pembrolizumab?

Pembrolizumab is an immunotherapy drug that helps your body's immune system recognise and fight cancer cells.

What does 'Phase 2' mean for a trial?

Phase 2 means the study is looking more closely at how well a new treatment works and if it's safe for people, after it's been shown to be generally safe in a smaller group.

Will I have radiotherapy?

Some people in the study might have radiotherapy if their doctors think it's needed, just like in standard care for Hodgkin Lymphoma.

What is chemotherapy?

Chemotherapy is a type of medicine that uses powerful chemicals to kill fast-growing cancer cells in the body.

How to find out more

Michael Fuchs

michael.fuchs@uk-koeln.de +49221478 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.