A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC) - R2810-ONC-1901

Regeneron Pharmaceuticals Inc.0 个研究点目标入组 6 人开始时间: 2022年8月5日最近更新: 2024年7月22日

试验速览

暂无简介。

•Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be =3 cm at the longest diameter., At least 1 lesion that is measurable by RECIST 1.1, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, Adequate organ, bone marrow function, and hepatic function as defined in the protocol NOTE: Other protocol defined Inclusion Criteria apply

•Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time, Distant metastatic disease (M1), visceral and/or distant nodal, Prior radiation therapy for CSCC, Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug., Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date, History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency, Active tuberculosis NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply

发起方

Regeneron Pharmaceuticals Inc.