2023-503418-63-00招募中2 期
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
Beigene Ltd.12 个研究点 分布在 3 个国家目标入组 28 人开始时间: 2023年10月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 12
- 主要终点
- Confirmed objective response rate (ORR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1.
研究概览
简要总结
To assess the antitumor activity of tislelizumab plus investigational agent(s)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
- •Eastern Cooperative Oncology Group Performance Status of 0 or
- •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).
排除标准
- •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.
结局指标
主要结局
Confirmed objective response rate (ORR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1.
Confirmed objective response rate (ORR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1.
次要结局
- Progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and disease control rate (DCR) as assessed by the investigators per RECIST v1.1.
- The incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) in reference arm (tislelizumab alone) and experimental arms (tislelizumab plus investigational agent[s]).
- Overall Survival (OS).
研究者
BeiGene Clinical Support
Scientific
Beigene Ltd.
研究点 (12)
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