RecruitingPHASE2INTERVENTIONAL

Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients

This study is investigating a new medication, Cemiplimab, for people with a type of skin cancer called advanced basal cell carcinoma (BCC). This is for patients whose cancer hasn't been treated with specific 'hedgehog inhibitor' drugs before. The main goal is to find out how effective Cemiplimab is at shrinking or stopping the growth of the cancer when used as a first treatment. Researchers will also be checking for any side effects to make sure the treatment is safe. Patients will receive Cemiplimab given directly into a vein every three weeks for up to a year, or until the treatment is no longer working or side effects are too much. This is a Phase 2 trial, meaning it's still an early stage of testing this specific use of the drug.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrolment target

Start

07 Aug 2025

Estimated completion

01 Jul 2029

Basal Cell Carcinoma (BCC)First Line Treatment

What is this study about?

This study is trying to understand more about a new treatment called Cemiplimab for a common type of skin cancer known as basal cell carcinoma (BCC). Specifically, it's for people with more advanced BCC that doctors can't easily remove with surgery or treat with radiation. It's also for those who haven't yet tried certain other medications called 'hedgehog inhibitors'. The goal is to see if Cemiplimab can be an effective and safe first treatment option for these patients.

Researchers want to see how well Cemiplimab fights the cancer, measuring if the cancer shrinks or stops growing. They will also carefully watch for any side effects to make sure the treatment is safe for patients. This type of study, a Phase 2 trial, helps us learn more about how a new treatment works before it's made widely available.

Patients taking part will receive Cemiplimab into their vein every three weeks. This will continue for up to a year, unless the treatment stops working, or side effects become too difficult to manage. Throughout the study, doctors will regularly check the cancer and the patient's health to understand the treatment's impact.

Key takeaways

Tests a new drug (Cemiplimab) for advanced basal cell skin cancer.
For patients who haven't used certain other drugs for their BCC before.
Treatment given every 3 weeks into a vein for up to a year.
Monitors how well the drug works and its safety.
Involves regular check-ups and tumour samples.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of locally advanced basal cell carcinoma (BCC) that can't be treated easily with surgery or radiation, or if these treatments aren't suitable for you. You must also not have been treated with certain other specific drugs called 'hedgehog inhibitors' for your BCC before.

Your general health needs to be good enough to take part. This means having an expected survival of at least six months and your blood tests (like blood count, and how well your kidneys and liver are working) should be within a healthy range. You'll also need to be able to sign a form saying you understand the study and agree to participate. Women who could become pregnant and men with partners who could become pregnant will need to use effective contraception during the study.

If you have other serious health problems, or if you've recently had severe side effects from previous treatments that haven't cleared up, you might not be able to join. The medical team will check all these details carefully to make sure the study is right and safe 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.

Are you 18 years old or older?
Do you have locally advanced basal cell carcinoma that doctors can't easily operate on or radiate?
Have you NOT been treated with specific 'hedgehog inhibitor' drugs for your BCC before?
Are your general health and blood test results within a healthy range?
Are you able to use effective contraception if you are a woman who could become pregnant, or a man with a partner who could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive the study drug, Cemiplimab, through a drip into your vein. This treatment will be given on the first day of every three-week cycle, and you could continue to receive it for up to 12 months (or a maximum of 17 doses). Throughout the study, you'll have regular check-ups, including scans and doctor's appointments, to see how the cancer is responding to the treatment. These check-ups will happen about every 12 weeks during treatment and also during a follow-up period.

Doctors will also take samples of your tumour, which will help them understand how Cemiplimab works and if there are specific signs in the tumour that predict who will benefit most from the treatment. You'll be carefully monitored for any side effects. The study will continue until the cancer gets worse, if you experience side effects that are too difficult to manage, or for up to 12 months after your last dose of Cemiplimab, or until death, whichever happens first.

Potential risks and benefits

Taking part in this study might offer a potential benefit if Cemiplimab helps to shrink or control your advanced basal cell carcinoma, especially if other treatments aren't suitable or haven't been tried. However, like all medications, Cemiplimab can have side effects. The research team will carefully monitor you for any potential risks and side effects, and they will explain them fully. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (7)

Helios Klinikum Erfurt
Verified postcode
Erfurt, Germany· Recruiting
Universitätsklinikum Erlangen
Verified postcode
Erlangen, Germany· Recruiting
Nationales Centrum für Tumorerkrankungen (NCT)
Verified postcode
Heidelberg, Germany· Recruiting
Universitätsklinikum Leipzig
Verified postcode
Leipzig, Germany· Recruiting
Johannes Wesling Klinikum
Verified postcode
Minden, Germany· Recruiting
Helios Klinikum Oberhausen
Verified postcode
Oberhausen, Germany· Recruiting
Universitätsklinikum Tübingen
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is Cemiplimab?

Cemiplimab is a drug being tested to treat advanced skin cancer.

What kind of cancer is this study for?

It's for advanced basal cell carcinoma (BCC), a common type of skin cancer.

How often will I receive the treatment?

You'll receive the treatment into your vein every three weeks.

How long will I be in the study?

You could be in the study for up to 12 months while receiving treatment, plus a follow-up period.

Can I stop participating in the study if I want to?

Yes, you can choose to stop participating at any time.

How to find out more

Ralf Gutzmer, Prof. Dr. med.

ralf.gutzmer@muehlenkreiskliniken.de +49 571/ 790 4501 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.