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

Conditions

• Locally Recurrent Skin Squamous Cell Carcinoma
• Metastatic Skin Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Amivantamab and Recombinant Human Hyaluronidase — DRUG
  Given SC
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Cetuximab — BIOLOGICAL
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI

Study Details

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.

Key Dates

First listed

Jun 29, 2025

Start date

Mar 23, 2026

Status verified

Jul 2026

Primary completion

Feb 28, 2029

Completion

Feb 28, 2029

Study Design

Enrollment

86 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (amivantamab and hyaluronidase)
  Patients receive amivantamab and hyaluronidase SC over at least 5 minutes on days 1, 8, 15 and 22 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study and CT scan and/or MRI throughout the study.
• Active Comparator: Arm II (cetuximab)
  Patients receive cetuximab IV over 60-120 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study and CT and/or MRI throughout the study.

Primary Outcome Measure

Incidence of toxicity of interest (cohort A) [ Time Frame: Up to completion of the first cycle (cycle length = 28 days) ]

Locations (38)

Find similar trials in Birmingham, AL

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