Treatment for Advanced Skin Cancer in People with a Weakened Immune System
What is the purpose of this clinical trial?
This clinical trial is for people who have advanced cutaneous squamous cell carcinoma (a type of skin cancer) and are immunocompromised (have a weakened immune system).
The study will compare 2 different medicines for advanced cutaneous squamous cell carcinoma:
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New approach Treatment with the medicine amivantamab (sometimes called amivantamab and hyaluronidase) |
Usual approach Treatment with the medicine cetuximab |
This trial is set up to find out:
- If amivantamab does a better job than cetuximab at keeping the cancer from growing or spreading
- If amivantamab does a better job than cetuximab at helping people live longer
- What side effects the treatments in the study cause
Why is this trial important?
Research shows that amivantamab works for treating other types of cancer, but this trial is the first to test how well the medicine works for treating advanced cutaneous squamous cell carcinoma.
It’s especially important that the study is for people who have a weakened immune system. That’s because they have fewer treatment options than people without a weakened immune system. And they’re more likely to have cancer that spreads or grows quickly.
In this study, researchers hope to learn if amivantamab is a better treatment option than cetuximab for this group of patients.
Who can be in this trial?
This trial is for adults age 18 or older who have cutaneous squamous cell carcinoma.
This trial may be for people who:
- Have a weakened immune system
- Have advanced cancer (cancer that has spread or can’t be treated with surgery)
This trial is not for people who:
- Received cetuximab or another EGFR inhibitor in the last year
- Have had interstitial lung disease or pneumonitis (conditions that cause scarring or swelling of the lungs)
- Have had a lung transplant
- Are pregnant or breastfeeding
What treatments will I get?
There are 2 parts in this study. Your doctor will tell you which part you’re in.
Part 1
As many as 10 people will receive amivantamab. (See the Group 1 box below for details.) The study doctors will watch this group carefully. If the drug doesn’t cause serious side effects and seems to work, the study will move on to Part 2.
Part 2
If you’re in Part 2, a computer will randomly assign you to one of these study groups.
Group 1: amivantamab (study treatment)
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Group 2: cetuximab (usual treatment)
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Your doctor will not have control over which group you’re assigned to. This helps make sure the study results are fair and reliable.
Treatment with amivantamab or cetuximab
Some patients have reactions to amivantamab or cetuximab. These reactions are more common with amivantamab, and they’re more likely to happen the first time you get the drug. Common reactions include chills, shortness of breath, fever, and reddened skin.
Depending on which group you’re in, you’ll receive 1 or more medicines to help prevent these reactions.
Your care team will talk to you about what to expect. Let them know if you have questions or concerns.
How long will I be in the trial?
You’ll be in the study for 3 years total.
You’ll receive either amivantamab or cetuximab for up to 2 years. No matter which drug you receive, you’ll have visits with your study doctor for 3 years so they can see how you’re doing and check to see if the cancer has grown or spread.
Are there costs? Will I get paid?
If you receive amivantamab for the study, you won’t need to pay for it.
To learn more about what costs will and won’t be covered, talk to your health care provider and insurance provider.
You will not be paid for joining the study.
Where can I find more information about this trial?
- Talk with your health care provider
- Call the National Cancer Institute at 1-800-4-CANCER
- Go to www.ClinicalTrials.gov and search the national clinical trial number: NCT07042295
- For a list of trial locations, visit swog.org/NCI-SN2426