A Randomized, Global, Open-label Study of Nivolumab in Combination With BMS-986205 vs Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1
研究概览
简要总结
This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.
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
- •Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN), from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx.
- •Recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
- •No prior treatment with systemic anti-cancer therapy for SCCHN, unless protocol specified criteria are met
- •ECOG Performance Status of 0-1
- •Measurable disease by CT or MRI per RECIST 1.1 criteria
排除标准
- •Women who are pregnant or breastfeeding
- •Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma)
- •Participants with untreated CNS metastases are excluded
- •Participants with carcinomatous meningitis
- •Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Nivolumab and BMS-986205
Nivolumab administered in combination with BMS-986205
干预措施: BMS-986205 (Drug)
EXTREME study regimen
Cetuximab + Cisplatin/Carboplatin + Fluorouracil
干预措施: Cetuximab (Biological)
EXTREME study regimen
Cetuximab + Cisplatin/Carboplatin + Fluorouracil
干预措施: Cisplatin (Drug)
EXTREME study regimen
Cetuximab + Cisplatin/Carboplatin + Fluorouracil
干预措施: Carboplatin (Drug)
Nivolumab and BMS-986205
Nivolumab administered in combination with BMS-986205
干预措施: Nivolumab (Biological)
EXTREME study regimen
Cetuximab + Cisplatin/Carboplatin + Fluorouracil
干预措施: Fluorouracil (Drug)
结局指标
主要结局
Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1
时间窗: Approximately 2 years
Overall survival (OS)
时间窗: Approximately 40 months
Objective response rate (ORR) determined by BICR using RECIST 1.1
时间窗: Approximately 2 years
次要结局
- Number of adverse events (AE)(Approximately 2 years)
- Number of serious adverse events (SAE)(Approximately 2 years)
- Time to meaningful symptomatic deterioration (TTSD)(Approximately 2 years)