CTRI/2026/01/100986招募中3 期
A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 6
研究概览
简要总结
The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5- fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Be more than or equal to 18 years of age
- •Have histologically or cytologically confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies a.
- •eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx b.
- •Must not have a primary tumor site of nasopharynx or primary tumor of unknown location c.
- •Must have documented local testing results per local regulations d.
- •Human papillomavirus status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization.
- •Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative
- •Be treatment-naive for systemic therapy in the recurrent or metastatic setting
- •Have an ECOG performance status of 0 or 1
- •Have measurable disease according to Response Evaluation Criteria in Solid Tumors, RECIST version 1.1.
排除标准
- •Have an uncontrolled illness
- •Have untreated brain metastases or history of known presence of leptomeningeal disease
- •Have a history of clinically significant cardiovascular disease
- •Inadequate organ or bone marrow function
- •Known allergies, hypersensitivity, contraindications, or intolerance to excipients of Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase.
研究者
Dr Sanish Davis
Johnson and Johnson Private Limited
研究点 (6)
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