Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Pharmacokinetics (PK) study to compare GME751 (proposed pembrolizumab biosimilar) and United States (US)-licensed and European Union (EU)-approved Keytruda®in participants with stage Ⅱ and Ⅲ skin cancer requiring adjuvant treatment (therapy applied after initial treatment of cancer to suppress the regrowth of tumor) with pembrolizumab.

This clinical trial is comparing a new medication called GME751 with an established cancer drug, Keytruda (pembrolizumab). Keytruda is already approved in the US and Europe. We are giving GME751 to adults who have been diagnosed with stage II or stage III skin cancer, specifically melanoma. These individuals need additional treatment after their initial cancer care, which doctors call 'adjuvant treatment.' The main goal is to understand how GME751 is processed by the body (this is called pharmacokinetics) and how it compares to Keytruda. This is an early-stage study, meaning it's focusing on how the drug behaves in the body rather than its effectiveness against the cancer itself. It's an important step in making sure new medicines are safe and work as expected.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

H e x a l AG

Enrolment target

136

Start

09 Apr 2024

Melanoma

What is this study about?

This study is about a new medicine called GME751. It's designed to be a 'biosimilar' to an existing and widely used cancer drug called Keytruda (the active ingredient is pembrolizumab). Think of a biosimilar as being very much like a generic version of a well-known drug, but for more complex, biologically-sourced medicines. The aim is to create a medicine that works in a very similar way to the original, offering another treatment option.

We are focusing on people who have been diagnosed with certain stages of skin cancer, specifically melanoma. After their initial treatment for melanoma, some people need extra treatment to help stop the cancer from coming back. This additional treatment is called 'adjuvant therapy.' The study is for those who would normally receive Keytruda as their adjuvant treatment.

The main purpose of this early-stage study is to carefully compare how GME751 travels through and is processed by the body, against how Keytruda acts. This includes looking at things like how quickly the medicine is absorbed, how long it stays in the blood, and how it is eventually removed. By understanding these 'pharmacokinetics,' researchers can ensure that GME751 behaves in a very similar way to Keytruda, which is a crucial step before it can be considered for wider use.

Key takeaways

This study is testing a new medicine (GME751) similar to Keytruda for melanoma.
It's for people with stage II or III melanoma needing adjuvant treatment.
The main aim is to see how the new medicine behaves in the body compared to Keytruda.
It's an early-stage study focusing on how the drug works, not how effective it is against cancer yet.
Participants must be 18 or older, both men and women are welcome.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adult volunteers. To be able to join, you must be 18 years old or older. There is no upper age limit, which means people of all adult ages can be considered.

Both men and women are welcome to take part in this study. The study team wants to include a wide range of people to make sure the results are useful for everyone.

Crucially, you would need to have been diagnosed with stage II or stage III melanoma, which is a type of skin cancer. You must also be at the stage where your doctors have recommended you receive additional treatment (adjuvant therapy) with pembrolizumab (Keytruda) after your initial cancer treatment.

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 been diagnosed with stage II or Stage III melanoma?
Has your doctor recommended pembrolizumab (Keytruda) as your adjuvant treatment?
Are you able to attend regular clinic visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the new medicine, GME751, or the approved Keytruda. You won't get to choose which one you receive, as this is decided randomly. The study will involve a series of visits to the clinic for measurements and to receive your treatment. These visits are essential for the research team to monitor your health and how your body is responding to the medication.

Throughout the study, you'll have regular medical assessments, which might include blood tests, physical exams, and other checks. This is to make sure you are safe and that the researchers can gather all the necessary information about how the medicine is working in your body. We don't have the exact duration or frequency of visits in this summary, but the study team would explain all of this in detail before you agree to join.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is contributing to medical science, which could lead to new treatment options for melanoma in the future. You would also receive close medical attention and monitoring throughout the trial. However, there's always a risk of side effects from any medication, and these could be different for different people. The study medication, whether it's GME751 or Keytruda, could cause reactions that vary from mild to severe, similar to known side effects of Keytruda. You would be fully informed about all known risks before deciding to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical 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
Romania
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Unverified
Germany
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Unverified
Italy
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Unverified
Lithuania
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Unverified
France
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Unverified
Spain

Common questions

What is a 'biosimilar' medicine?

A biosimilar is a medicine that is very similar to an existing, approved biological medicine. It's like a highly similar copy in terms of how it works and its safety.

Why is this study comparing GME751 to Keytruda?

Keytruda is an established treatment for melanoma. This study wants to confirm that GME751 acts in the body in a very similar way to Keytruda, which is important for it to be considered a new treatment option.

What does 'adjuvant treatment' mean?

Adjuvant treatment is extra therapy given after the main treatment for cancer (like surgery) to help reduce the chance of the cancer coming back.

Will I know if I'm getting GME751 or Keytruda?

In this type of study, often participants don't know which drug they are receiving. This is to ensure the study results are fair and unbiased. The study team would explain this fully.

How long would I need to be in the study?

The information provided doesn't specify the exact duration. The study team would give you detailed information about the time commitment involved during the consent process.