NCT06256588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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 864
- 试验地点
- 278
- 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 Head and Neck Squamous Cell Carcinoma (HNSCC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 Locally Advanced (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 biopsy obtained prior to CRT:
- •PD-L1 positive tumor status
- •If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 immunohistochemistry (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 (RT), systemic therapy, targeted therapy, or surgery for management of head and neck cancer not considered part of CRT. Participants receiving induction chemotherapy are excluded. CRT combinations with components other than cisplatin and RT (e.g., experimental agents, including radiosensitizers/radioprotectants, cetuximab) are not eligible.
- •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 more than one primary HNSCC tumor.
- •Has experienced any of the following with prior immunotherapy: any immune-related adverse event (irAE) of Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or Drug Rash with Eosinophilia and Systemic Symptoms [DRESS] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.
- •Has undergone any major surgical procedure or experienced significant traumatic injury that has not resolved by the time of randomization.
- •Has any history of interstitial lung disease or pneumonitis (past or current).
- •Has cirrhosis of any stage 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.
研究组 & 干预措施
Arm B: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Arm A: Dostarlimab
Experimental
干预措施: Dostarlimab (Drug)
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
Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event, where an event is defined as locoregional progression or recurrence, or distant metastasis per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as per BICR; Salvage surgery at the primary tumor site; Neck dissection or surgery performed \>20 weeks after completion of Concomitant Chemoradiotherapy (CRT) when invasive cancer is present or Death from any cause.
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
时间窗: Up to approximately 5 years
Event Free Survival (EFS) is defined as the time from the date of randomization to the date of an event, where an event is defined as locoregional progression or recurrence, or distant metastasis per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as per BICR; Salvage surgery at the primary tumor site; Neck dissection or surgery performed \>20 weeks after completion of Concomitant Chemoradiotherapy (CRT) when invasive cancer is present or Death from any cause.
次要结局
- 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 Anti-Drug Antibodies against Dostarlimab(Up to approximately 15 months)
- Overall Survival (OS)(Up to approximately 5 years)
- Event-free Survival (EFS) assessed by investigator(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)
- Number of Participants with TEAEs and SAEs leading to dose delays, withdrawals or death(Up to approximately 5 years)
- Serum Predose trough concentration (Ctrough) of Dostarlimab(Up to approximately 15 months)
研究者
研究点 (278)
Loading locations...
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