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This study evaluates the drug Cemiplimab alone and together with RP1 in treating advanced cutaneous squamous cell carcinoma of the skin. It can enroll patients with histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma who have at least one measurable, injectable lesion. It is being conducted in Phase 2 and is currently not recruiting but still ongoing (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Key Inclusion Criteria: * Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma * Patients with locally advanced disease who are not suitable candidates for surgical or radiological treatment of lesions or have refused those treatments * At least 1 lesion that is measurable and injectable by study criteria * Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG PS 2 at baseline may be allowed to enroll if PS 2 status is only related to the CSCC disease under study * Anticipated life expectancy \>12 weeks * All patients must consent to provide archived or newly obtained tumor material for central pathology review for confirmation of diagnosis of CSCC. Key Exclusion Criteria: * Prior treatment with an oncolytic therapy * Patients with active significant herpetic infections or prior complications of HSV-1 infection (e.g. herpetic keratitis or encephalitis) * Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g. acyclovir) * Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments * Prior treatment with an agent that blocks the PD-1/PD-L1 pathway. * Prior treatment with other immune modulating agents other than as adjuvant or neoadjuvant therapy within 3 years. * Untreated brain metastasis(es) that may be considered active. * Acute or chronic active hepatitis B or known history of hepatitis B or hepatitis C or human immunodeficiency virus (HIV) infection * History of ILD/pneumonitis within the last 5 years or a history of ILD/pneumonitis requiring treatment with systemic steroids. * Any major or surgical procedure ≤ 28 days before randomization * Administration of live vaccines ≤ 28 days before randomization Note: Other protocol defined Inclusion/Exclusion criteria apply.