Clinical Trial TitleA 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.
National Clinical Trial Number:NCT04050436
Clinical Trial Protocol Description:
The purpose of this study is to compare the effects of cemiplimab alone against a combination of cemiplimab and RP1(trial drug) in patients with advanced cutaneous squamous cell carcinoma (CSCC). Additionally, this study investigates whether cemiplimab in combination with RP1 can reduce the size of your tumor(s) better than cemiplimab alone, by helping the immune system destroy the tumor(s). The study is also being done to obtain information on the safety of cemiplimab in combination with RP1 in patients.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma.
- Subjects for whom surgical or radiological treatment of lesions is contraindicated.
- Have at least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).
- Consent to provide archived or newly obtained tumor material for central pathology review for confirmation of diagnosis of CSCC.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior treatment with an oncolytic therapy.
- Have active significant herpetic infections or prior complications of HSV-1 infection (e.g. herpetic keratitis or encephalitis).
- Require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g. acyclovir).
- Have ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.