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Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
Bu çalışma, ileri evre deri skuamöz hücreli karsinomunun (cutaneous squamous cell carcinoma) tedavisinde Cemiplimab ilacını tek başına ve RP1 ile birlikte değerlendirmektedir. Çalışmaya, histolojik olarak doğrulanmış lokal ileri ya da metastatik deri skuamöz hücreli kanseri olan, ölçülebilir ve enjeksiyona uygun en az bir lezyonu bulunan hastalar katılabilmektedir. Faz 2 aşamasında yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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.