CTRI/2024/06/068865招募中3 期
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 (JADE)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 864
- 试验地点
- 15
- 主要终点
- Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with HNSCC (Head and Neck Squamous Cell Carcinoma)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 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.
- •NOTE: Tumors to be staged according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging manual (Amin, 2017).
- •NOTE: For eligibility assessment: TNM stage for oropharyngeal HNSCC must be based on p16 status as determined by CINtec assay.
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 enrolment.
- •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, CD134).
- •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)
时间窗: Up to approximately 5 years
次要结局
- Overall Survival (OS)(Up to approximately 5 years)
- Event-free Survival (EFS) assessed by investigator(Up to approximately 5 years)
- Number of Participants with treatment emergent adverse events (TEAEs), Immune-mediated TEAEs, and serious adverse events (SAEs) by severity(Up to approximately 5 years)
- Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death(Up to approximately 5 years)
- Number of participants with clinically significant changes in laboratory, vital signs, and safety assessment parameters(Up to approximately 5 years)
- Serum Concentration of Dostarlimab(Up to approximately 15 months)
- Serum Concentration of Dostarlimab at End of Infusion (C-EoI)(Up to approximately 15 months)
- Serum Predose trough concentration (Ctrough) of Dostarlimab(Up to approximately 15 months)
- Number of Participants with Anti-Drug Antibodies against Dostarlimab(Up to approximately 15 months)
研究者
Dr Gaurav Deshmukh
GSK Pharma India Private Limited
研究点 (15)
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