A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 1,145
- 试验地点
- 316
- 主要终点
- Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
研究概览
简要总结
The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).
- •Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).
- •Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent prior to randomization.
排除标准
- •Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with >1 primary tumors are not eligible for the study.
- •Participants with any of the following:
- •LA-HNSCC that was resected before definitive cCRT
- •LA-HNSCC that was treated and is recurrent at the time of screening
- •Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.
研究组 & 干预措施
Observation Arm
Patients in this arm will undergo observation.
Study Arm
Participants in this arm will receive volrustomig.
干预措施: volrustomig (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
时间窗: Up to approximately 8 years
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression). The analysis will include all randomized participants with PD-L1 expressing tumors.
Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
时间窗: Up to approximately 8 years
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression). The analysis will include all randomized participants with PD-L1 expressing tumors.
次要结局
- Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors(Up to approximately 8 years)
- Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population(Up to approximately 8 years)
- Landmark Progression-Free Survival (PFS) Rates(Up to approximately 8 years)
- Landmark Overall Survival (OS) Rates(Up to approximately 8 years)
- Overall Survival (OS) in the unresected LA-HNSCC ITT population(Up to approximately 8 years)
- Progression Free Survival 2 (PFS2)(Up to approximately 8 years)
- Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum(Up to approximately 8 years)
- Participant-reported physical functioning(Up to approximately 8 years)
- Participant-reported global health status (GHS)/quality of life (QoL)(Up to approximately 8 years)
- Percentage of participants with Adverse Events(Up to approximately 8 years)
- Area under the curve (AUC)(Up to approximately 8 years)
- Maximum plasma concentration of the drug (Cmax)(Up to approximately 8 years)
- The time taken to reach the maximum concentration (Tmax)(Up to approximately 8 years)
- Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population(Up to approximately 8 years)
- Landmark Progression-Free Survival (PFS) Rates(Up to approximately 8 years)
- Landmark Overall Survival (OS) Rates(Up to approximately 8 years)
- Overall Survival (OS) in the unresected LA-HNSCC ITT population(Up to approximately 8 years)
- Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum(Up to approximately 8 years)
- Progression Free Survival 2 (PFS2)(Up to approximately 8 years)
- Participant-reported physical functioning(Up to approximately 8 years)
- Participant-reported global health status (GHS)/quality of life (QoL)(Up to approximately 8 years)
- Percentage of participants with Adverse Events(Up to approximately 8 years)
- Maximum plasma concentration of the drug (Cmax)(Up to approximately 8 years)