A Phase II Study of Cemiplimab Immunotherapy Alone and with RP1 in People with Cutaneous Squamous Cell Carcinoma

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Full Title

A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination with RP1 in Patients with Advanced Cutaneous Squamous Cell Carcinoma

Purpose

Cemiplimab is an immunotherapy used to treat a kind of skin cancer called advanced cutaneous squamous cell carcinoma. In this study, researchers are comparing the safety and effectiveness of cemiplimab plus the investigational drug RP1 versus cemiplimab alone in patients with metastatic cutaneous squamous cell carcinoma.

RP1 is a herpes simplex virus (commonly known as the cold sore virus) that has been genetically changed. RP1 causes the herpes simplex virus to spread from tumor cell to tumor cell and turn on the immune system to attack cancer cells. It is given as an injection into the tumor.

Cemiplimab works by blocking a protein called PD-1 that normally acts as a brake on the immune system. Blocking this protein is like releasing the brake, enabling the immune system to target cancer cells and destroy them. Cemiplimab is given intravenously (by vein). Patients will be randomly assigned to receive cemiplimab alone or with RP1.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have locally advanced or metastatic cutaneous squamous cell carcinoma.
  • At least 30 days must pass since the completion of prior anticancer medications and 2 weeks since prior radiation therapy and receipt of the study treatment. Previous immunotherapy is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Lara Dunn at 646-608-3787.

Protocol

20-353

Phase

II

Investigator

Co-Investigators