Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)

This study, called KEYNOTE-C11, is exploring a new way to treat classical Hodgkin lymphoma, a type of cancer that starts in white blood cells. It's for adults who have just been diagnosed. The study combines a drug called pembrolizumab (also known as Keytruda) with several common chemotherapy medicines. Pembrolizumab works by helping your body's immune system fight cancer. Researchers want to find out how effective this combination treatment is and if it can lead to complete remission, meaning there are no signs of cancer left. They will also be carefully checking for any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

25 Aug 2023

Classical Hodgkin Lymphoma

What is this study about?

This clinical trial is designed to investigate a new treatment approach for classical Hodgkin lymphoma, a type of cancer that affects the lymphatic system, which is part of your body's immune system. When someone is diagnosed with classical Hodgkin lymphoma for the first time, medical teams often use chemotherapy as a main treatment. This study is testing if adding a newer type of drug, pembrolizumab, to standard chemotherapy could improve outcomes.

Pembrolizumab, also known as Keytruda, is an immunotherapy drug. This means it works by helping your body's own immune system recognise and fight cancer cells more effectively. Researchers hope that by combining pembrolizumab with chemotherapy, they might achieve better results, such as more patients going into a 'complete response' or 'complete remission'. This means all signs of the cancer have disappeared.

The main goal of this study is to see how many patients achieve a complete response at the end of the treatment. They will also be monitoring how long this response lasts and carefully tracking any side effects or problems that might come up during the treatment. This helps doctors understand if the combined treatment is safe and effective.

Key takeaways

This study is testing a new combination treatment for classical Hodgkin lymphoma.
It combines standard chemotherapy with an immunotherapy drug called pembrolizumab.
The main goal is to see how many patients achieve complete remission.
Participation involves regular clinic visits for treatment, tests, and monitoring.
It's for adults newly diagnosed with classical Hodgkin lymphoma.
You can stop participating at any time.

Who may be eligible?

This study is open to adults who are at least 18 years old. Both men and women can take part. A key requirement is that you must have a recent diagnosis of classical Hodgkin lymphoma and have not yet started treatment for it.

To ensure your safety and that the study can properly evaluate the new treatment, the medical team will need to check your general health. They will look at your overall fitness and confirm that you don't have certain other health conditions that might make the treatment unsafe or interfere with the study results.

There might be other specific health requirements or conditions that would prevent someone from joining, which your doctor would discuss with you in detail. These are put in place to protect participants and make sure the study provides helpful information.

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?
Have you recently been diagnosed with classical Hodgkin lymphoma?
Have you not yet started treatment for your Hodgkin lymphoma?
Are you generally well enough to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given a combination of drugs including pembrolizumab and several chemotherapy medicines, administered as infusions. These treatments will take place over a period of time, and the medical team will schedule regular visits to the clinic.

During these visits, you'll have various assessments, including blood tests, physical examinations, and scans (like PET scans) to monitor your health and see how the treatment is working. The study will carefully track how your cancer responds, whether it goes into remission, and for how long. You'll also be closely monitored for any side effects.

The total duration of your participation will involve the treatment period and follow-up appointments to ensure your well-being and to collect all necessary information. Your study team will explain the full schedule and commitment involved.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing new treatments before they are widely available, which in this case could potentially lead to a better response for your Hodgkin lymphoma. However, like all medical treatments, there are potential risks, including side effects from the drugs. Some of these side effects might be new or unknown. The medical team will monitor you very closely for any issues and will explain all known risks. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
France
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Unverified
Poland
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Unverified
Spain
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Unverified
Italy

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 your lymph nodes and other parts of your body.

What is pembrolizumab (Keytruda)?

It's an immunotherapy drug that helps your body's own immune system find and fight cancer cells more effectively.

What does 'complete response' mean?

A complete response, or complete remission, means that all signs of the cancer have disappeared based on medical tests and scans.

Are there side effects?

All medicines can have side effects. The study team will closely monitor you for any side effects from the chemotherapy and pembrolizumab and will discuss them with you.

Will I automatically get this new treatment?

If you join the study, you will receive the combination of pembrolizumab and chemotherapy as part of the trial's experimental arm. This is a Phase 2 study, meaning the treatment is still under investigation.