Active not recruitingPHASE3INTERVENTIONAL

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

This study is investigating a new medication called cemiplimab for people with a high-risk type of skin cancer called cutaneous squamous cell carcinoma. Participants in this study have already had surgery and radiotherapy to treat their cancer. The main goal is to find out if cemiplimab can prevent the cancer from returning after these treatments. Currently, there isn't an approved treatment given after surgery and radiotherapy to stop this high-risk cancer from coming back. We also want to see if cemiplimab helps people live longer and if it's safe. Half the participants will get cemiplimab, and the other half will get a placebo (a dummy drug).

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Regeneron Pharmaceuticals

Enrolment target

415

Start

04 Jun 2019

Estimated completion

07 Jan 2028

Cutaneous Squamous Cell Carcinoma

What is this study about?

This study is about a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that is considered 'high-risk.' This means that even after having surgery and radiation therapy, there's a chance the cancer could come back. At the moment, there isn't a standard treatment given after these initial treatments to lower the chance of the cancer returning.

We're testing a new medication called cemiplimab. This drug is a type of 'monoclonal antibody,' which is a specially made protein designed to help your body's immune system fight cancer. Cemiplimab works by blocking a specific signal that cancer cells use to hide from your immune system. By blocking this signal, we hope it will allow your immune system to better recognise and attack any remaining cancer cells, stopping them from growing or spreading.

The main aim of this study is to see if cemiplimab can prevent this high-risk skin cancer from returning after surgery and radiation. We also want to find out if it helps people live longer, if it makes it less likely for new cancer spots to appear close by or in other parts of the body, and if it is safe to use. Half the people in the study will receive cemiplimab, and the other half will receive a placebo which looks just like the study drug but doesn't contain any active medicine. This comparison helps us understand if any improvements are truly due to cemiplimab.

Key takeaways

This study is for people with high-risk skin cancer (CSCC) that's been surgically removed and treated with radiotherapy.
It tests if a new drug, cemiplimab, can stop the cancer from coming back.
Participants will receive either cemiplimab or a placebo as a drip into a vein.
The study involves regular check-ups and follow-up for several years.
Joining is voluntary, and you can withdraw anytime.

Who may be eligible?

This study is looking for people who have had a high-risk type of cutaneous squamous cell carcinoma (a serious form of skin cancer) that has been completely removed by surgery. You must have also finished your radiation therapy treatment for this cancer within 2 to 10 weeks before joining the study.

To join, you need to be at least 18 years old and in generally good health, meaning you can carry out your normal daily activities without much difficulty. Your liver, kidney, and bone marrow should be working well. This study is not for you if your cancer has already spread to other organs far away from the original site. Also, if you have other types of cancer or certain serious existing health conditions, especially those related to your immune system, you might not be able to take part.

Quick self-check

I have been diagnosed with high-risk cutaneous squamous cell carcinoma.
My cancer has been completely removed by surgery.
I have finished my radiation therapy within the last 2 to 10 weeks.
I am generally able to go about my daily activities without much difficulty.
My cancer has not spread to distant parts of my body.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll first have a screening period (up to 28 days) to ensure you meet all the requirements. If eligible, you'll start the treatment phase, which lasts about 48 weeks. You will receive either cemiplimab or a placebo, given as a drip into a vein every three weeks for the first 12 weeks. After that, you'll receive the drip every six weeks.

During the study, you'll have regular visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. After the treatment period, you'll have an end-of-treatment visit and then enter a follow-up period that could last up to 5 years. During follow-up, your health will continue to be monitored, and doctors will look for any signs of the cancer returning.

There's also an optional Part 2 to the study. If your cancer were to come back and you were initially given the placebo, you might have the option to receive cemiplimab during this second part.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new treatment that might help prevent your skin cancer from returning. However, there are also potential risks, as cemiplimab can have side effects, which the study team will discuss with you. You might also receive a placebo, meaning you wouldn't get the active study drug. Your health will be closely monitored throughout the study. Remember, joining is entirely voluntary, and you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (166)

Banner MD Anderson Cancer Center
Gilbert, United States
Mayo Clinic Hospital
Phoenix, United States
Regeneron Study Site
Tucson, United States
The Angeles Clinic
Los Angeles, United States
University of Southern California (USC)
Los Angeles, United States
Stanford Cancer Institute, Stanford Medicine at Stanford University
Palo Alto, United States
University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco, United States
George Washington University School of Medicine and Health Sciences
Washington D.C., United States
University of Florida Health
Gainesville, United States
Sylvester Comprehensive Cancer Center
Miami, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, United States
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
Tampa, United States

+154 more sites — see the official record for the full list.

Common questions

What is cutaneous squamous cell carcinoma?

It's a common type of skin cancer that starts in the top layer of the skin. 'High-risk' means it's more likely to come back or spread after treatment.

What is cemiplimab?

Cemiplimab is a new drug designed to help your body's own immune system fight cancer cells by blocking a specific protein.

What is a placebo?

A placebo looks just like the study drug but doesn't contain any active medicine. We use it to compare against the real drug to see if the medicine works.

How long will I be in the study?

The treatment part lasts about 48 weeks. After that, you'll be followed up for several years, possibly up to 5 years, to see how you're doing.

Will I know if I'm getting cemiplimab or the placebo?

No, you won't know directly, nor will your study doctor. This is to ensure fair and unbiased results. Afterwards, you might have the option to get the actual drug if your cancer returns.