A Randomized, Phase 2, Open-Label, Multi-Arm Study of Tislelizumab in Combination With Investigational Agents as First-Line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma - BGB-HNSCC-201

Beigene Ltd.0 个研究点目标入组 160 人开始时间: 2023年7月17日最近更新: 2024年7月22日

适应症

试验速览

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•Subjects with histologically or cytologically confirmed recurrent or metastatic (R/M) HNSCC that is considered incurable by local therapies: a. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx; b. Subjects should not have had prior systemic therapy administered in the R/M setting; systemic therapy which was completed prior to randomization/enrollment if given as part of multimodal treatment for locally or locoregionally advanced disease is allowed., Subjects must have positive PD-L1 expression (Combined Positive Score [CPS] = 1)., Have at least 1 measurable lesion as defined per RECIST v1.1., Eastern Cooperative Oncology Group Performance Status of 0 or 1., Adequate hematologic and organ function as indicated by specific laboratory values within 7 days of first dose of study drug., Willing to use a highly effective method of birth control for the duration of the study and for = 120 days after the last dose of study drug(s).

•Recurrent or metastatic carcinoma of the nasopharynx (any histology), squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland primary tumor or non-squamous histologies (eg, mucosal melanoma)., Prior therapy with an anti-PD-1, anti-PD-L1, PD-L2, T-cell immunoglobulin and mucin domain containing-3 (TIM-3), LAG-3, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways., Any active malignancy = 2 years before randomization/enrollment except for the specific cancer under investigation in this study, those with a negligible risk of metastasis or death, and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, and carcinoma in situ of the cervix or breast)., History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, and acute lung diseases., A history of severe hypersensitivity reactions to other monoclonal antibodies or has experienced a severe immune-mediated adverse event (imAE), an imAE that led to treatment discontinuation, or a cardiac or ocular imAE of any grade with prior immunotherapy.

发起方

Beigene Ltd.