Phase II Randomized Study Comparing Amivantamab with Hyaluronidase to Cetuximab in Immunocompromised Adults with Recurrent or Metastatic Skin Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating treatments for people with skin squamous cell carcinoma that has returned or spread, focusing on those with weakened immune systems. This phase II trial compares amivantamab combined with hyaluronidase to cetuximab, both monoclonal antibodies, to see how they affect disease progression and safety. The study seeks to understand if amivantamab with hyaluronidase is as effective as cetuximab in controlling locally recurrent or metastatic disease in immunocompromised patients. Participants receive either amivantamab and hyaluronidase injected under the skin on specific days during 28-day cycles or cetuximab given intravenously on days 1 and 15 of each cycle. Treatment may continue for up to 24 cycles, provided the disease does not worsen and side effects remain acceptable. Throughout the study, patients undergo blood sample collections and imaging scans like CT or MRI to monitor their disease. Participants are involved in regular assessments including physical exams and tumor evaluations by CT or MRI. Researchers measure treatment safety by tracking toxicities in the first treatment cycle and evaluate progression-free survival over up to three years. Secondary outcomes include overall survival, time to next treatment, and response duration, with follow-up extending up to five years. Specimens may also be collected for future research. Total participation can last several years, including treatment and follow-up periods.

Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System