A PHASE II, RANDOMIZED, DOUBLE-BLIND STUDY OF ATEZOLIZUMAB PLUS TIRAGOLUMAB AND ATEZOLIZUMAB PLUS PLACEBO AS FIRST-LINE TREATMENT IN PATIENTS WITH RECURRENT/METASTATIC PD-L1 POSITIVE SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK. - .

F. Hoffmann-La Roche Ltd0 个研究点目标入组 120 人开始时间: 2020年12月29日最近更新: 2024年7月29日

适应症

试验速览

暂无简介。

•Age >= 18 years
•Participants histologically or cytologically confirmed recurrent/metastatic SCCHN involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies
•Known results from human papillomavirus status test for oropharyngeal carcinoma
•No prior systemic therapy for metastatic and/or recurrent SCCHN
•Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1
•Tumor PD-L1 expression as determined by PD-L1 IHC assay in either a previously obtained archival tumor tissue or tissue obtained from a biopsy at prescreening/screening
•Eastern Cooperative Oncology Group Performance Status of 0 or 1
•Adequate hematologic and end-organ function.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN
•Rapidly progressing disease in the opinion of the treating investigator
•Grade >= 2 unresolved toxicity related to surgery or other prior therapies
•Symptomatic, untreated, or actively progressing central nervous system metastases
•History of leptomeningeal disease
•Active or history of autoimmune disease or immune deficiency
•History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
•History of additional malignancy other than SCCHN within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death
•Severe infection within 4 weeks prior to initiation of study treatment
•Current treatment with anti-viral therapy for HBV or HCV
•Treatment with investigational therapy within 28 days prior to initiation of study treatment
•Prior treatment with CD137 agonists or immune checkpoint blockade therapies
•Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment
•Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.

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