Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Stage III and Stage IV Melanoma in the Adjuvant Setting

This study is testing a new medicine, ABP 206, to see if it acts in the body in the same way as an approved medicine called Opdivo (nivolumab). Both medicines are used after surgery for certain stages of melanoma, which is a type of skin cancer. The main goal is to find out if ABP 206 can be as effective and safe as Opdivo. This is important because developing similar versions of existing medicines can help make treatments more widely available and affordable in the future. Participants will be adults who have had their melanoma removed, and the study will look at how the body handles the new medicine.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Amgen Inc.

Enrolment target

156

Start

21 Jun 2023

Resected Melanoma Stage III or Stage IV

What is this study about?

This research study is comparing a new medicine called ABP 206 with an already approved medicine named Opdivo (nivolumab). Both medicines are used for people who have had a type of skin cancer called melanoma removed. Specifically, it's for those with 'Stage III' or 'Stage IV' melanoma, which means the cancer had spread slightly beyond the original spot but has now been surgically removed. The aim of these medicines is to help prevent the cancer from coming back.

The main thing this study wants to find out is if ABP 206 acts in the body in a very similar way to Opdivo. They are looking at how the body absorbs, breaks down, and gets rid of the medicine. If ABP 206 is found to be very similar, it could mean that it might work just as well as Opdivo in treating melanoma after surgery.

Studies like this are important because they can lead to more choices for patients and the healthcare system. If a new medicine is shown to be just as effective as an existing one, it can sometimes help make treatments more accessible or potentially reduce costs in the long run. This particular study is an early stage study, focusing on the science of how the medicine behaves in the body.

Key takeaways

This study compares a new medicine (ABP 206) with an existing one (Opdivo) for melanoma.
It's for adults who have had Stage III or IV melanoma removed by surgery.
The main goal is to see if the new medicine behaves similarly in the body.
This type of study helps make new treatments available.
Participation involves clinic visits and blood tests.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study welcomes both men and women.

Crucially, you must have been diagnosed with certain stages of melanoma (Stage III or Stage IV) and have had surgery to remove it. This means the cancer itself is no longer visible, but the treatment aims to help stop it from returning.

There will be other detailed health checks to make sure the study medicine is safe for you and that you meet all the requirements. Your doctors and the study team will go through these with you carefully.

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 III or Stage IV melanoma?
Have you had surgery to remove your melanoma?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a series of visits to the clinic over a certain period. During these visits, you would receive the study medicine, either ABP 206 or Opdivo, usually given into a vein. You would also have blood tests to see how the medicine is working in your body, and possibly other check-ups to monitor your health.

The exact number of visits, how long each visit lasts, and the total duration of your involvement in the study will be fully explained by the study team. You would also have follow-up appointments after you stop taking the medicine to ensure your well-being. All procedures would be outlined clearly before you decide to participate.

Potential risks and benefits

Potential benefits of joining the study include receiving closely monitored medical care and potentially having access to a new medicine that could be as effective as current treatments. However, like all medicines, ABP 206 and Opdivo can have side effects. These will be fully explained to you before you consider joining. There is no guarantee of personal benefit. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

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

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Unverified
Italy
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Unverified
Germany
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Unverified
Netherlands
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Unverified
France
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Unverified
Spain
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Unverified
Croatia
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Unverified
Lithuania
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Unverified
Romania

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that develops in the cells that produce melanin, the pigment that gives your skin its colour. It can spread to other parts of the body if not treated.

What does 'adjuvant setting' mean?

In this context, 'adjuvant setting' means the treatment is given after the main treatment (in this case, surgery to remove the melanoma) to help prevent the cancer from coming back.

What is Opdivo (nivolumab)?

Opdivo is an approved medicine that works with your body's immune system to fight cancer. It's often used for certain types of melanoma after surgery.

What does 'pharmacokinetic similarity' mean?

This refers to whether the new medicine (ABP 206) behaves in a very similar way inside your body to the existing medicine (Opdivo). It looks at things like how much medicine reaches your bloodstream and how long it stays there.

Will I know if I'm getting the new medicine or Opdivo?

Often in these types of studies, participants don't know which medicine they are receiving to keep the results fair and unbiased. The study team will explain how this works.