NCT07042295
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This Phase II clinical trial explores whether a combination of two drugs, amivantamab and hyaluronidase, is as effective as the standard treatment, cetuximab, for advanced skin cancer. Specifically, the study focuses on cutaneous squamous cell carcinoma that has either returned in the same area or spread to other parts of the body. Both amivantamab and cetuximab are a type of protein called monoclonal antibodies, which are designed to find and block signals that cancer cells use to grow. The addition of hyaluronidase aims to help amivantamab stay in the body longer to increase its impact.
This study is specifically looking for participants who have a weakened immune system. This includes people with certain blood cancers (like CLL or lymphoma), organ transplant recipients, or those taking immunosuppressant medications for an autoimmune disease like rheumatoid arthritis or lupus. To join, your cancer must be advanced enough that surgery or radiation are no longer the best options. You should not have received cetuximab or a similar drug in the past year.
If you participate, you will be assigned to receive either the amivantamab combination or cetuximab. These treatments are given as injections under the skin or through an IV infusion. You will also have regular blood tests and imaging scans, such as CT or MRI, to monitor your health and see how the cancer responds. Before enrolling, talk with your doctor about your immune system history, your current medications, and any past lung or heart conditions to ensure this study is a safe option for you.
Generated · Written by an AI model from the trial’s public ClinicalTrials.gov record. Not medical advice.
This phase II trial compares the effect of amivantamab and hyaluronidase to cetuximab for the treatment of skin (cutaneous) squamous cell carcinoma that has come back after a period of improvement and has not spread to other parts of the body (locally recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Amivantamab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Hyaluronidase is an endoglycosidase. It helps to keep amivantamab in the body longer, so that the medications will have a greater effect. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Giving amivantamab and hyaluronidase may be as effective as cetuximab for the treatment of locally recurrent or metastatic cutaneous squamous cell carcinoma.
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Banner MD Anderson Cancer Center
Gilbert, Arizona
Site Public Contact · 602-747-9738
UC San Diego Moores Cancer Center
La Jolla, California
Site Public Contact · 858-822-5354 · cancercto@ucsd.edu
Yale University
New Haven, Connecticut
Site Public Contact · 203-785-5702 · canceranswers@yale.edu
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut
Site Public Contact · 203-785-5702 · canceranswers@yale.edu
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut
Site Public Contact · 203-785-5702 · canceranswers@yale.edu