Study on Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People with a Weakened Immune System
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT07042295
This clinical trial is comparing two treatments, amivantamab with hyaluronidase and cetuximab, for advanced skin cancer in people with weakened immune systems. The study aims to see which treatment is more effective in controlling skin cancer that has returned or spread.
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Program Overview
This phase II study is testing two different treatments for advanced skin cancer, specifically cutaneous squamous cell carcinoma, in people with weakened immune systems. The trial compares the effects of amivantamab combined with hyaluronidase to cetuximab. Amivantamab is a type of protein that may help stop cancer cells from growing, while hyaluronidase helps keep it in the body longer. Cetuximab is another protein that targets cancer cells. The study aims to find out if amivantamab and hyaluronidase are as effective as cetuximab in treating this type of skin cancer.
Description
The main goals of this study are to evaluate the safety and effectiveness of amivantamab alone in patients with advanced skin cancer and a weakened immune system, and to compare how long patients live without the cancer getting worse when treated with either amivantamab or cetuximab.
Secondary goals include assessing the side effects of each treatment, how well the cancer responds, and how long the response lasts. The study will also look at how these treatments work in different groups of patients based on why their immune system is weakened, such as due to a transplant or autoimmune disease.
Participants in the study will be divided into two groups. One group will receive amivantamab and hyaluronidase under the skin on specific days of each treatment cycle, which repeats every 28 days for up to 24 cycles. The other group will receive cetuximab through an IV on specific days of each cycle, also repeating every 28 days for up to 24 cycles. Throughout the study, participants will have blood tests and scans to monitor their health and the cancer's response to treatment. After completing the treatment, participants will be followed up for up to three years.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of cutaneous squamous cell carcinoma.
- Must have measurable or non-measurable disease as assessed by specific scans.
- Must have a weakened immune system due to conditions like leukemia, lymphoma, organ transplant, or autoimmune disease under treatment.
- Must not have had prior treatment with cetuximab or similar drugs in the past year.
- Must be 18 years or older.
- Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
- Must have adequate blood counts and organ function based on specific medical tests.
- Must not have a history of certain lung diseases or lung transplants.
- Must not have uncontrolled illnesses or infections.
- Must not be pregnant or nursing and must agree to use effective contraception during the study and for six months after.
- Must be willing to participate in specimen banking for future research.
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