A Randomized Phase II Study of Amivantamab (JNJ-61186372) and Hyaluronidase (rHuPH20) Versus Cetuximab in Immunocompromised Participants With Recurrent Inoperable or Metastatic Cutaneous Squamous Cell Carcinoma

Summary

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Amivantamab and Recombinant Human Hyaluronidase

  Given SC

• Procedure
  Biospecimen Collection

  Undergo blood sample collection

• Biological
  Cetuximab

  Given IV

• Procedure
  Computed Tomography

  Undergo CT scan

• Procedure
  Magnetic Resonance Imaging

  Undergo MRI

Locations (31)