Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab with Brentuximab Vedotin in Subjects with Relapsed or Refractory Classical Hodgkin Lymphoma

This important study is testing two different medicines, pembrolizumab (also known as KEYTRUDA) and brentuximab vedotin (also known as ADCETRIS), for adults living with Hodgkin lymphoma. This is a type of cancer that affects the immune system. We're focusing on people whose Hodgkin lymphoma has either returned after previous treatment or hasn't improved with other medicines. The study is designed to compare these two treatments to see which is more effective at stopping the cancer from growing and spreading, and to learn if one helps people live longer than the other. This type of research, known as a Phase III trial, helps doctors understand the best ways to treat specific conditions.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

114

Start

11 Nov 2022

Hodgkin lymphoma

What is this study about?

This study, called a clinical trial, is specifically for adults who have Hodgkin lymphoma. This is a type of cancer that starts in white blood cells called lymphocytes, which are part of your body's immune system. The trial is focused on individuals whose Hodgkin lymphoma has either come back after they've already had treatment, or hasn't responded well to other medicines they've tried.

The main goal of this research is to compare two existing cancer medicines: pembrolizumab (which you might hear called KEYTRUDA) and brentuximab vedotin (also known as ADCETRIS). Both of these medicines are used in cancer treatment, and this study aims to find out which one works better for this particular group of patients. Researchers want to see if one medicine is more effective at stopping the cancer from growing and spreading, and if it helps people live longer and have a better quality of life.

By carefully comparing these two treatments, doctors hope to gain a clearer understanding of the best way to treat Hodgkin lymphoma that has returned or is hard to treat. This kind of study helps improve future treatments for everyone with this condition, ensuring that patients receive the most effective and appropriate care possible.

Key takeaways

This study is for adults with Hodgkin lymphoma that has returned or not responded to prior treatments.
It compares two medicines, pembrolizumab (KEYTRUDA) and brentuximab vedotin (ADCETRIS).
The aim is to find out which medicine better controls the cancer and helps people live longer.
Participation involves regular clinic visits, blood tests, and scans.
You will know which of the two medicines you are receiving.
You can stop participating in the study at any time.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Your doctor will check your medical history and do some tests to make sure that taking part in this specific study would be suitable and safe for you. This includes making sure your Hodgkin lymphoma has either come back after previous treatment or hasn't responded to other medicines.

It's important to remember that not everyone with Hodgkin lymphoma will be able to join. There are other specific health checks and criteria that your doctor will review to see if this study is the right fit for your situation.

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 18 years old or older?
Do you have Hodgkin lymphoma?
Has your Hodgkin lymphoma come back after treatment, or not responded to previous medicines?
Are you able to travel to regular clinic appointments?
Are you interested in learning more about new treatment options?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive either pembrolizumab or brentuximab vedotin as an infusion through a vein. Medicines would be given on a regular schedule, which your study doctor and nurse will explain in detail.

You would have regular visits to the clinic for assessments. These visits would include physical exams, blood tests, and scans (like CT scans) to see how your body is responding to the treatment and if the cancer is changing. These evaluations are important for the study team to monitor your health and the effectiveness of the treatment.

After you finish your treatment, there will be follow-up appointments. These are important for checking your long-term health and how you're doing after the study medicine has stopped. The total duration of your participation in the study, including treatment and follow-up, will be explained fully by the study team, but it could last for several years.

Potential risks and benefits

Taking part in a clinical trial might offer you early access to new treatments that aren't yet widely available, and it helps doctors learn more about your condition. However, there are potential risks, as with any medicine. The study medicines might cause side effects, and some may be serious. The study team will explain all known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden
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Unverified
Czechia
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Unverified
Poland
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Unverified
France
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Unverified
Germany
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Unverified
Italy

Common questions

What is Hodgkin lymphoma?

Hodgkin lymphoma is a type of cancer that affects the lymphatic system, which is part of your body's immune system. It's named after Dr. Thomas Hodgkin, who first described it.

What's the difference between pembrolizumab and brentuximab vedotin?

Both are medicines used to treat cancer, but they work in different ways to target cancer cells. This study aims to find out if one is more effective than the other for certain people with Hodgkin lymphoma.

What does 'relapsed or refractory' mean?

This means your Hodgkin lymphoma has either come back after previous treatment (relapsed) or it hasn't responded well to other medicines you've already tried (refractory).

Will I know which medicine I'm getting?

Yes, this is an 'open-label' study, which means you and your doctors will know whether you are receiving pembrolizumab or brentuximab vedotin.

How long will the study last for me?

Your participation would involve the treatment period and then a follow-up period. The exact length will vary depending on your individual response and the study design, but your study team will give you a clear timeline.