2025-521917-24-00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-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
- 22
- 试验地点
- 9
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
To compare anti-tumor activity
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Have histologically or cytologically confirmed R/M HNSCC that is considered incurable by local therapies.
- •Be treatment-naïve for systemic therapy in the R/M setting.
- •18 years and older with ECOG 0-1
- •Have measurable disease according to RECIST v1.1
排除标准
- •Uncontrolled illness
- •Has untreated brain metastases or history or known presence of leptomeningeal disease
- •Has a history of clinically significant cardiovascular disease
- •Inadequate organ or bone marrow function
结局指标
主要结局
Overall Survival (OS)
Overall Survival (OS)
次要结局
- 1. PFS (using RECIST v1.1), as assessed by BICR
- 2. ORR as assessed by BICR
- 3. DOR as assessed by BICR
- 4. ORR as assessed by the investigator
- 5. Incidence and severity of TEAEs and laboratory abnormalities
- 6. Proportion of participants with improved or stable symptoms relative to baseline, as measured by the EORTC QLQ-HN43 and symptom scales of the EORTC QLQ-C30
- 7. Change from baseline in functioning and overall HRQoL, as measured by functioning and global health scales of the EORTC QLQC30
- 8. Differences between treatment groups in the EORTC IL46 tolerabilityscale scores
- 9. Serum amivantamab concentrations and serum anti-amivantamab antibodies
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (9)
Loading locations...
相似试验
招募中
2 期
SKB500 Combinations in Patients With Small Cell Lung CancerSmall Cell Lung CancerNCT07296809Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.80
尚未招募
1 期
Study of TYK-01054 Capsules in Patients With Advanced Solid TumorsNCT07282873TYK Medicines, Inc219
尚未招募
1 期
JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast CancerMetastatic Breast CancerNCT07336771Jiangsu Alphamab Biopharmaceuticals Co., Ltd60
招募中
3 期
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or BHemophiliaNCT07285460Sanofi85
尚未招募
2 期
A Phase III Randomized Study of TACE Plus an Oral Triple-Agent Cocktail Versus TACE Plus First-Line Targeted Immunotherapy in Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaNCT07309419Shanghai Zhongshan Hospital222