2025-524648-37-00招募中3 期
A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan with or Without Bevacizumab Compared to Trifluridine/Tipiracil plus Bevacizumab in Participants with Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 323
- 试验地点
- 54
- 主要终点
- Arm 1, 2 and 3: overall survival (OS)
研究概览
简要总结
- To demonstrate improvement in overall survival with Precemtabart Tocentecan as single agent compared to Trifluridine/Tipiracil plus Bevacizumab.
- To demonstrate improvement in overall survival with Precemtabart Tocentecan in combination with bevacizumab compared to Trifluridine/Tipiracil plus Bevacizumab.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting.
- •Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting
- •ECOG Performance Status less than equal to 1
- •Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations
- •Other protocol defined inclusion criteria may apply
排除标准
- •If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute – Common Terminology Criteria for Adverse Events version 6.0
- •Participant has a history of additional malignancy within 3 years before randomization
- •Participants with known brain metastases
- •Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization
- •Participants with ileus ≥ Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn’s disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator’s opinion, might significantly interfere with proper absorption of the study treatments
- •Other protocol defined exclusion criteria may apply
研究组 & 干预措施
Avastin 25 mg/ml concentrate for solution for infusion., Avastin 25 mg/ml concentrate for solution for infusion.
Test
干预措施: Avastin 25 mg/ml concentrate for solution for infusion. (Drug)
M9140
Test
干预措施: M9140 (Drug)
Lonsurf 15 mg/6.14 mg film-coated tablets, Lonsurf 15 mg/6.14 mg film-coated tablets, Lonsurf 20 mg/8.19 mg film-coated tablets, Lonsurf 20 mg/8.19 mg film-coated tablets, Lonsurf 20 mg/8.19 mg film-coated tablets, Lonsurf 15 mg/6.14 mg film-coated tablets
Comparator
干预措施: Lonsurf 15 mg/6.14 mg film-coated tablets (Drug)
Lonsurf 15 mg/6.14 mg film-coated tablets, Lonsurf 15 mg/6.14 mg film-coated tablets, Lonsurf 20 mg/8.19 mg film-coated tablets, Lonsurf 20 mg/8.19 mg film-coated tablets, Lonsurf 20 mg/8.19 mg film-coated tablets, Lonsurf 15 mg/6.14 mg film-coated tablets
Comparator
干预措施: Lonsurf 20 mg/8.19 mg film-coated tablets (Drug)
结局指标
主要结局
Arm 1, 2 and 3: overall survival (OS)
Arm 1, 2 and 3: overall survival (OS)
次要结局
- Arm 1 and Arm 2: overall survival (OS)
- Progression free survival (PFS)
- Objective response (OR) according to RECIST v1.1 as assessed by Investigator
- Duration of response (DoR) according to RECIST v1.1 as assessed by Investigator
- Number of Participants with Adverse Events (AEs) and Treatment Related Adverse Events
- Observed Concentration at End of Infusion (CEOI)
- Concentration Observed at the end of a Dosing Interval Immediately Before next Dosing (Ctrough)
- Number of Participants with Anti-Drug Antibody as measured by ADA assay
- Change from Baseline in Global Health Status, Physical, and Role Functioning Subscale Scores of European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
研究者
Global Regulatory Affairs
Scientific
Merck Healthcare KGaA
研究点 (54)
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