jRCT2041230133招募中不适用
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to evaluate Dostarlimab as Sequential Therapy after Chemoradiation in Participants with Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
GlaxoSmithKline K.K.0 个研究点目标入组 864 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 864
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply,
- •Has newly diagnosed unresected LA histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy (termed 'CRT' in this protocol) with curative intent and has no evidence of distant metastatic disease.
- •Has provided acceptable core or excisional tissue demonstrating,
- •PD-L1 positive tumor status
- •If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 IHC testing.
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Has adequate organ function.
排除标准
- •Participants are excluded from the study if any of the following criteria apply,
- •Has received prior radiation therapy, systemic therapy, targeted therapy, or radical surgery for management of head and neck cancer not considered part of CRT.
- •Has cancer outside of the oropharynx, larynx, hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer.
- •Has undergone any major surgical procedure or experienced significant traumatic injury within 28 days prior to enrollment.
- •Has any history of interstitial lung disease or pneumonitis (past or current).
- •Has cirrhosis or current unstable liver biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
- •Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate, in the opinion of the investigator.
- •Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention.
- •Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., Cytotoxic T-lymphocyte associated protein 4 (CTLA4), OX-40, CD137).
- •Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 120 days after the last dose of study intervention.
- •Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab or its excipients.
结局指标
主要结局
-
Event-free survival (EFS) assessed by blinded independent central review (BICR)
次要结局
未报告次要终点
研究者
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