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.
Participants must have pathologically proven diagnosis of cutaneous squamous cell carcinoma based on pathology from original diagnosis or from a metastatic/recurrent lesion
Participants must have measurable or non-measurable disease per RECIST 1.1 and must have their disease assessed by CT or MRI of chest/abdomen/pelvis (with contrast unless contraindicated) within 28 days prior to registration for measurable disease or within 42 days prior to registration for non-measurable disease. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Any lesions assessed using a non-diagnostic positron emission tomography (PET)/CT of chest/abdomen/pelvis will be considered non-measurable lesions. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration to be considered measurable
NOTE: All diseases must be assessed and documented on the baseline tumor assessment form
Participants with exclusively locally recurrent disease must have either a contraindication to surgical treatment of lesions (i.e., complete resection is not possible or not expected to be clinically beneficial or resection conferring significant cosmetic or functional concerns) or have refused surgical or radiation treatment
None
Parallel
Amivantamab and Recombinant Human Hyaluronidase
DrugGiven SC
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Cetuximab
Biological/VaccineGiven IV
Computed Tomography
Procedure/SurgeryUndergo CT scan
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Incidence of toxicity of interest (cohort A)
Defined as grade 3 or 4 skin rash that does not recover within 14 days, grade 3 or 4 non-hematologic toxicity that does not recover within 7 days, grade 4 hematologic toxicity including febrile neutropenia or organ transplant failure (for transplant patients only).
Progression free survival (PFS) (cohort B)
Organ rejection
Will be monitored for participants with prior organ transplants.
Overall survival (OS)
Will estimate OS by cohort and treatment arm and within subgroups using the method of Kaplan-Meier. OS will be compared between arms using an un-stratified log-rank test. The hazard ratio and 95% confidence interval from an un-stratified Cox regression model with treatment as the only covariate will be descriptively reported for OS.
PFS
Will estimate PFS by cohort and treatment arm and within subgroups using the method of Kaplan-Meier.
Time to next treatment
will be estimated using cumulative incidence curves with death before event accounted for as a competing event.
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