NCT03833661已完成2 期
A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 33
- 主要终点
- Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
研究概览
简要总结
The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- •Ampullary cancer was excluded
- •Significant acute or chronic infections
- •Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- •Interstitial lung disease or its history
- •Participants who were not eligible for or have not been treated with 1L systemic chemotherapy
- •Anticancer treatment within 21 days before the start of study intervention
- •Concurrent treatment with nonpermitted drugs
- •Prior participation in a M7824 clinical trial
- •Prior therapy with other immunotherapy or checkpoint inhibitors, such as anti-PD 1, anti PD L1, anti- cytotoxic T-cell lymphocyte-4 (CTLA-4) antibodies.
- •Pregnancy or breast feeding
- •Systemic anticancer treatment after failing 1L platinum-based chemotherapy
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
M7824
Experimental
干预措施: M7824 (Drug)
结局指标
主要结局
Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
时间窗: Time from first treatment up to 555 days
Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC.
次要结局
- Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator(Time from first administration of study drug until the first documentation of PD or death, assessed up to data-cutoff (736 days))
- Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)(Time from first treatment to data cutoff (assessed up to 736 days))
- Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)(Time from first administration of study drug until the first documentation of PD or death, assessed up to data-cutoff (736 days))
- Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator(Time from first treatment to data cutoff (assessed up to 736 days))
- Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)(Time from first documentation of objective response to data cutoff (assessed up to 736 days))
- Serum Pre-Dose Concentrations (Ctrough) of M7824(At Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421 and Day 505)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs)(Time from first treatment to data cutoff (assessed up to 736 days))
- Durable Response Rate (DRR) Acoording to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator(Time from first treatment to data cutoff (assessed up to 736 days))
- Serum Concentration at End of Infusion (CEOI) of M7824(At Day 1 and Day 29)
- Number of Participants With Positive Antidrug Antibodies (ADA)(Time from first treatment to data cutoff (assessed up to 736 days))
- Percentage of Participants With Confirmed Objective Response as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) According to Microsatellite Instability (MSI) Status(Time from first treatment to data cutoff (assessed up to 736 days))
- Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression(Time from first documentation of objective response to data cutoff (assessed up to 736 days))
- Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator(Time from first documentation of objective response to data cutoff (assessed up to 736 days))
- Overall Survival (OS)(Time from first administration of study drug to data cutoff (assessed up to 736 days))
- Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status(Time from first documentation of objective response to data cutoff (assessed up to 736 days))
- Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status(Time from first treatment to data cutoff (assessed up to 736 days))
- Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression(Time from first treatment to data cutoff (assessed up to 736 days))
- Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression(Time from first treatment to data cutoff (assessed up to 736 days))
研究者
研究点 (33)
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