Active not recruitingPHASE2INTERVENTIONAL

Abscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy

This study is for people with a type of blood cancer called Hodgkin Lymphoma that has returned or not responded to earlier treatments, especially those that block a protein called PD-1. Researchers want to see if combining a powerful drug, Nivolumab, with a short course of radiotherapy can improve treatment. Nivolumab is already very good at fighting this cancer, but it doesn't always lead to a complete recovery. Radiotherapy at specific sites might help the body's immune system work even harder alongside Nivolumab, potentially leading to better results not just in the treated area but throughout the body. The main goal is to find out if this combination can make Nivolumab more effective.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University of Cologne

Enrolment target

Start

05 Dec 2019

Estimated completion

04 May 2025

Classical Hodgkin Lymphoma

What is this study about?

This research study is looking at a new way to treat Hodgkin Lymphoma, a type of cancer that affects the immune system. Specifically, it's for people whose lymphoma has either come back after treatment or hasn't responded well to previous medicines, particularly a group of drugs called anti-PD1 therapies.

The main medicine being studied is called Nivolumab. It's a type of immunotherapy that helps your own immune system recognise and fight cancer cells. Nivolumab has been shown to be effective for Hodgkin Lymphoma, but sometimes it doesn't completely clear the cancer, and some patients find their cancer continues to grow despite treatment. The study aims to improve these results.

Researchers want to see if adding a small amount of radiotherapy to certain areas of the body can make Nivolumab work even better. The idea is that this localised radiotherapy might 'wake up' the immune system in a way that helps Nivolumab attack cancer cells not just where the radiation was given, but throughout the entire body. This effect is sometimes called an 'abscopal effect'. By combining these two treatments, the hope is to achieve a stronger and more lasting effect against the lymphoma.

Key takeaways

The study combines Nivolumab (an immunotherapy drug) with radiotherapy.
It's for Hodgkin Lymphoma that has come back or not responded to previous anti-PD1 treatments.
The aim is to make Nivolumab more effective by 'boosting' the immune system with radiation.
Researchers hope to see a wider effect from the treatment, not just in the radiated area.
It's a Phase 2 study, meaning it's still in earlier stages of testing.
Participation requires careful checking of your specific cancer situation.

Who may be eligible?

This study is looking for adults aged 18 or older who have classical Hodgkin Lymphoma. To be considered, your lymphoma must have either returned or not responded well to a previous treatment that targeted a protein called PD-1. You'll also need to have at least two areas of lymphoma that show up on a special scan (called an FDG-PET scan), and these areas must be far enough apart. One of these areas must be suitable to receive a small dose of radiotherapy, based on where it is and if you've had radiation before in that spot.

There are also some reasons why you wouldn't be able to join. For example, if you have a different, rarer type of Hodgkin Lymphoma (called Nodular Lymphocyte Predominant Hodgkin Lymphoma) or a related condition called greyzone lymphoma. You also can't take part if your lymphoma has spread to your brain or spinal cord. Finally, if you've never had treatment with an anti-PD1 drug before, this study wouldn't be suitable for you.

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.

I am 18 years old or older.
I have classical Hodgkin Lymphoma.
My lymphoma has either relapsed (come back) or didn't respond to a previous anti-PD1 treatment.
My doctors have identified at least two distinct areas of lymphoma.
One of these lymphoma areas can safely receive a small amount of radiotherapy.
I have not had lymphoma spread to my brain or spinal cord.

Answer every question to see your result.

What does participation involve?

The detailed plan for taking part isn't fully described here, but generally, clinical trials involve regular hospital visits. These visits typically include physical examinations, blood tests, and scans to monitor your health and how the treatment is working. You would receive the study medicine, Nivolumab, and a short course of radiotherapy to a specific area of your lymphoma. You would be carefully followed up by the study team for a period of time to check for any side effects and to see how effective the treatment is. The overall duration of the study, including follow-up, would be made clear to you before you decide to participate.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new and potentially more effective treatment for your Hodgkin Lymphoma, especially if current standard treatments haven't worked well. However, all medical treatments carry risks. You might experience side effects from Nivolumab, radiotherapy, or the combination. Possible general side effects of Nivolumab include fatigue, skin rash, or sometimes effects on different organs, while radiotherapy can cause temporary skin changes or tiredness in the treated area. The research team will explain all known and potential risks in detail. Remember, deciding to participate is entirely your choice, and you are free to withdraw from the study at any time without affecting your future medical care.

Locations (1)

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

Common questions

What is classical Hodgkin Lymphoma?

It's a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system. It can affect lymph nodes and other parts of the body.

What is Nivolumab?

Nivolumab is a type of immunotherapy. It helps your body's own immune system to find and fight cancer cells more effectively.

What is radiotherapy?

Radiotherapy uses high-energy rays to kill cancer cells in a specific area of the body. In this study, a small dose would be given to a particular lymphoma site.

What does 'abscopal effect' mean?

It's a special effect where treating one area of cancer with radiotherapy can sometimes help the immune system fight cancer cells in other, untreated parts of the body.

Is this a new treatment approach?

The use of Nivolumab is established, but combining it with targeted radiotherapy to potentially boost its effects in this specific way for Hodgkin Lymphoma is what this study is investigating.