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-Naïve 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
- 203
- 主要终点
- Overall Survival (OS)
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
- 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 more than or equal to (>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater)
- •Have histologically or cytologically confirmed recurrent/metastatic (R/M) 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 (HPV) 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 (ISH). Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative
- •Be treatment-naive for systemic therapy in the R/M setting
- •Have an ECOG performance status of 0 or 1
- •Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).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
研究组 & 干预措施
Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or Cisplatin
Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).
干预措施: 5-Flurouracil (Drug)
Arm A: Pembrolizumab, Amivantamab, Carboplatin
Participants will receive pembrolizumab, amivantamab and carboplatin.
干预措施: Pembrolizumab (Biological)
Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or Cisplatin
Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).
干预措施: Carboplatin (Drug)
Arm A: Pembrolizumab, Amivantamab, Carboplatin
Participants will receive pembrolizumab, amivantamab and carboplatin.
干预措施: Amivantamab (Biological)
Arm A: Pembrolizumab, Amivantamab, Carboplatin
Participants will receive pembrolizumab, amivantamab and carboplatin.
干预措施: Carboplatin (Drug)
Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or Cisplatin
Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).
干预措施: Cisplatin (Drug)
Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or Cisplatin
Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 3 years 7 months
OS is defined as time from the date of randomization to the date of death due to any cause.
Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
时间窗: Up to approximately 3 years 7 months
ORR is defined as the percentage of randomized participants achieving a confirmed best overall response (BOR) of partial response (PR) or complete response (CR) by BICR using RECIST version 1.1 .
次要结局
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)(Up to approximately 3 years 7 months)
- Change from Baseline in Overall HRQoL, as Measured by Global Health Scales of the EORTC QLQ-C30(Baseline, up to approximately 3 years 7 months)
- Serum Concentration of Amivantamab(Up to approximately 3 years 7 months)
- Number of Participants with Serum Anti-Amivantamab Antibodies(Up to approximately 3 years 7 months)
- Duration of Response (DOR) As Assessed by BICR(Up to approximately 3 years 7 months)
- Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 43 (EORTC QLQ-HN43) Symptom Scale Score(Baseline, up to approximately 3 years 7 months)
- Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by EORTC QLQ-Core (C) 30 Symptom Scale Score(Baseline, up to approximately 3 years 7 months)
- Change from Baseline in Functioning HRQoL, as Measured by Functioning Scales of the EORTC QLQ-C30(Baseline, up to approximately 3 years 7 months)
- Differences Between Treatment Groups (Arms A and B) for EORTC Quality of Life (QLG) Item Library-46 (IL-46) Tolerability Scale Scores(Up to approximately 3 years 7 months)
- Progression-Free Survival (PFS) Using RECIST Version 1.1, as Assessed by BICR(Up to approximately 3 years 7 months)
- ORR as Assessed by Investigator(Up to approximately 3 years 7 months)
- Number of Participants with Laboratory Abnormalities(Up to approximately 3 years 7 months)