2023-503956-29-00招募中3 期
CA209-8HW A Phase 3 Randomized Clinical Trial of Nivolumab alone, Nivolumab in Combination with Ipilimumab, or Investigator’s Choice Chemotherapy in Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 571
- 试验地点
- 56
- 主要终点
- Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed)
研究概览
简要总结
All lines:
- To compare PFS by BICR between nivolumab plus ipilimumab arm (arm B) vs nivolumab arm (arm A) 1L:
- To compare PFS by BICR between nivolumab plus ipilimumab arm (arm B) vs chemotherapy arm (arm C)
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
- 是
入选标准
- •Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study)
- •Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery (Applicable during Part 2 enrollment of the study)
- •Known tumor MSI-H or dMMR status per local standard of practice
- •Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1
- •Other protocol-defined inclusion/exclusion criteria apply
排除标准
- •Participants with an active, known or suspected autoimmune disease
- •History of interstitial lung disease or pneumonitis
- •Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed)
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) (arm B vs A, all lines, centrally confirmed)
PFS by BICR (arm B vs C, 1L, centrally confirmed)
PFS by BICR (arm B vs C, 1L, centrally confirmed)
次要结局
- Overall Response Rate (ORR) by BICR (arm B vs A, all lines, centrally confirmed)
- Overall Survival (OS) (arm B vs A, all lines, centrally confirmed)
- PFS by Investigator Assessment (arm B vs A, all lines, centrally confirmed)
- PFS by BICR among all randomized participants (arm B vs A, all lines, per local testing)
- PFS by BICR (arm B vs A, 1L, centrally confirmed)
- ORR by BICR (arm B vs C, 1L, centrally confirmed)
- ORR by BICR (arm B vs A, 1L, centrally confirmed)
- OS (arm B vs A, 1L, centrally confirmed)
- PFS by BICR (arm A vs C, 1L, centrally confirmed)
- OS (arm B vs C, 1L, centrally confirmed)
- ORR by BICR (arm A vs C, 1L, centrally confirmed)
- OS (arm A vs C, 1L, centrally confirmed)
- PFS by Investigator (arm A, B and C, 1L, centrally confirmed)
- PFS by BICR (arm B vs A, all lines, by each central test)
- PFS by BICR among all randomized participants who have not received prior treatment (arm B vs C, 1L, per local testing)
- PFS by BICR among all randomized participants who have not received prior treatment (arm B vs A, 1L, per local testing)
- PFS by BICR (arm B vs C, 1L, by each central test)
- ORR by BICR (crossover cohort, centrally confirmed)
- PFS by BICR (crossover cohort, centrally confirmed)
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation
研究点 (56)
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