A Phase II Study of Radiation Therapy and Cemiplimab Immunotherapy for People with Inoperable Skin Cancer

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Full Title

A Phase II, Multicenter, Single-Arm Clinical Trial of Definitive Radiotherapy And CeMiPlimAb-Rwlc ImmunoTherapy for Locally Advanced, Unresectable Cutaneous Squamous Cell Carcinoma: RAMPART

Purpose

The purpose of this study is to see if combining radiation therapy and cemiplimab immunotherapy is an effective treatment for people with inoperable cutaneous squamous cell carcinoma (a type of skin cancer) that is relatively large or has spread beyond its original location to nearby lymph nodes or nerves. Cemiplimab boosts the ability of the immune system to find and kill cancer cells. Radiation therapy is a standard treatment for squamous cell skin cancer. Researchers believe that cemiplimab may make radiation therapy more effective. Cemiplimab is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have stage III or IV cutaneous squamous cell skin cancer that cannot be surgically removed.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Christopher Barker at 212-639-8168.

Protocol

22-090

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed

Investigator

ClinicalTrials.gov ID

NCT05574101