Phase IIa/IIb Clinical Trial of NC-6004 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Failed Platinum or a Platinum-containing Regimen
试验速览
- 阶段
- 2 期
- 入组人数
- 136
- 试验地点
- 23
- 主要终点
- Compare median Progression Free Survival (PFS) between NC-6004 +pembrolizumab and pembrolizumab alone
研究概览
简要总结
In Phase IIa, dose-escalation study to determine the optimum tolerated dose and a recommended Phase IIb (RPIIb) dose in combination with pembrolizumab in subjects with recurrent or metastatic squamous cell carcinoma of the head and neck who have failed platinum or a platinum containing regimen.
In Phase IIb, randomized control study between NC-6004 in combination with pembrolizumab versus pembrolizumab alone in the same subject population as Part 1 at the RPIIb dose identified in PIIa.
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
- •Be willing and able to provide written informed consent for the trial.
- •Males or females aged ≥18 years at screening.
- •Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Have histologically- or cytologically-confirmed HNSCC.
- •Have recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies.
- •Having prior platinum failure.
排除标准
- •Subjects with carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary origination, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, nonsquamous histologies.
- •Have disease that is suitable for locoregional treatment administered with curative intent or refuses curative intent.
- •Have no more than 15% body weight loss due to the underlying condition in the last 3 months from signing of informed consent in Part 1 of the study and from randomization in to Part
- •Are currently participating in or have participated in a study of an investigational agent or are using an investigational device within 4 weeks prior to the first dose of trial treatment.
- •Were previously treated with 3 or more lines of systemic therapies administered for recurrent and/or metastatic disease.
研究组 & 干预措施
NC-6004 +pembrolizumab
NC-6004 should be administered to subjects once every 3 weeks. On Day 1 of each treatment cycle NC-6004 will be administered first followed by pembrolizumab.
In phase IIa portion, NC-6004 dose goes up from 90 mg/m2 up to 135 mg/m2. In phase IIb portion, the dose should be the determined RPII dose in phase IIa portion.
干预措施: NC-6004 (Drug)
NC-6004 +pembrolizumab
NC-6004 should be administered to subjects once every 3 weeks. On Day 1 of each treatment cycle NC-6004 will be administered first followed by pembrolizumab.
In phase IIa portion, NC-6004 dose goes up from 90 mg/m2 up to 135 mg/m2. In phase IIb portion, the dose should be the determined RPII dose in phase IIa portion.
干预措施: Pembrolizumab (Drug)
Pembrolizumab
The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Compare median Progression Free Survival (PFS) between NC-6004 +pembrolizumab and pembrolizumab alone
时间窗: 1 year
In PIIb portion, to compare PFS between NC-6004 plus pembrolizumab and pembrolizumab alone.
Determine the Recommended Phase (RPII) dose (mg/m2) of NC-6004 in combination with pembrolizumab
时间窗: 1 year
In PIIa portion, to determine RPII dose of NC-6004 in combination with pembrolizumab
次要结局
- Safety and tolerability as measured by severity of Adverse Events (AEs)(1 year)
- Compare overall response (complete response and partial response) rate between NC-6004 +pembrolizumab and pembrolizumab alone(1 year)
- Assess the Time to Maximum Concentration (Tmax) of NC-6004 in combination with pembrolizumab(1 year)
- Assess the Half-life(T½) of NC-6004 in combination with pembrolizumab(1 year)
- Assess the Clearance (CL) of NC-6004 in combination with pembrolizumab(1 year)
- Compare median Overall Survival (OS) between NC-6004 +pembrolizumab and pembrolizumab alone(2 years)
- Compare duration of response between NC-6004 +pembrolizumab and pembrolizumab alone(1 year)
- Assess the Maximum Plasma Concentration (Cmax) of NC-6004 in combination with pembrolizumab(1 year)
- Compare time to response between NC-6004 +pembrolizumab and pembrolizumab alone(1 year)
- Assess the Volume of Distribution (V) of NC-6004 in combination with pembrolizumab(1 year)
- Assess the Area Under the Concentration (AUC) of NC-6004 in combination with pembrolizumab(1 year)