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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Cutaneous Squamous Cell Carcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Histologically confirmed diagnosis of invasive cutaneous squamous cell carcinoma that is locally advanced and is considered metastatic. 2) Patients for whom surgical or radiological treatment of lesions is not advised. 3) Females of childbearing potential who have a negative urine pregnancy test at screening and on Day 1 prior to dosing. 4) Male and female subjects of reproductive potential who are willing to use a highly effective method of birth control or contraception, or who are surgically sterile, or abstain from heterosexual activity for the course of the study and for 6 months after last dose of study drug.

You may not be eligible for this study if the following are true:

  • 1) Prior treatment with an oncolytic therapy, PD-1/PD-L1 inhibitors, or other immune modulating agents other than as adjuvant or neoadjuvant therapy. 2) Patients with active significant herpetic infections or prior complications of HSV-1 infection. 3) Known infection including active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV). 4) Patients who are breast feeding. 5) Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that, in the opinion of the investigator, renders the patient unsuitable for participation in a clinical trial due to high safety risks and/or potential to affect interpretation of results of the study.


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