NCT04969861终止2 期
A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin Combined With Pembrolizumab Versus Pembrolizumab Alone in First-Line Treatment of Patients With Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma With PD-L1 Expressing Tumors (PROPEL-36)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Overall Survival
研究概览
简要总结
This is a multicenter, randomized, open-label, Phase 2/3 study that will evaluate the efficacy and safety of bempegaldesleukin (BEMPEG; NKTR-214) combined with pembrolizumab compared with pembrolizumab monotherapy in patients with recurrent or metastatic HNSCC with positive PD-L1 expression (CPS ≥ 1).
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
- None
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
- •Provide written, informed consent to participate in the study and follow the study procedures.
- •Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
- •Have histologically or cytologically-confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies.
- •No prior systemic therapy for recurrent or metastatic disease.
- •The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- •Patients may not have a primary tumor site of nasopharynx (any histology) and/or unknown primary.
- •Have measurable disease based on RECIST 1.1 as determined by the local site Investigator.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Measure Description: GRADE - ECOG PERFORMANCE STATUS
- •0 - Fully active, able to carry on all pre-disease performance without restriction
- •1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work
- •2- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
- •The tumor must have positive PD-L1 expression (i.e., CPS ≥1)
排除标准
- •Has disease that is suitable for local therapy administered with curative intent.
- •Has progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
- •Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to initiation of study drug
- •Has a life expectancy of less than 3 months and/or has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) as determined by the Investigator.
- •Has a known additional malignancy that is progressing or has required active treatment within 5 years prior to the first dose of study drug
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy
- •Use of an investigational agent or an investigational device within 28 days before the first dose of study drug.
- •Prior treatment with an anti PD-1, anti PD-L1, anti-PD-L2, or anti CTLA-4 antibody, agents that target IL-2 pathway, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- •NOTE: Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BEMPEG + Pembrolizumab
Experimental
Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years).
干预措施: Bempegaldesleukin (Drug)
BEMPEG + Pembrolizumab
Experimental
Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years).
干预措施: Pembrolizumab (Drug)
Pembrolizumab Monotherapy
Active Comparator
Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years).
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Overall Survival
时间窗: Approximately 2 years
Objective Response Rate
时间窗: Approximately 2 years
To compare the objective response rate (ORR) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.
次要结局
- Progression-Free Survival(Approximately 2 years)
- Time to Deterioration(Approximately 2 years)
- Change in Global Health Status/Quality of Life(Approximately 2 years)
- Percentage of Patients With Treatment-Emergent Adverse Events and Serious Adverse Events(Screening baseline through end of study, approximately 2 years)
研究者
研究点 (4)
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