A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,041
- 试验地点
- 136
- 主要终点
- Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs)
研究概览
简要总结
A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.
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
- •Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
- •Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
- •No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
- •Tissue or Programmed death-ligand 1 (PD-L1) results available
- •Cohort 1A Inclusion Criteria:
- •Eastern Cooperative Oncology Group (ECOG) score 2 or
- •Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol
- •Cohort C Inclusion Criteria:
- •High Tumor Mutation Burden
排除标准
- •Untreated brain metastases
- •An active malignancy that requires concurrent intervention
- •Active, known or suspected autoimmune disease
- •Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Nivolumab in combination with Ipilimumab
Specified dose on specified days
干预措施: Nivolumab in combination with Ipilimumab (Drug)
结局指标
主要结局
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs)
时间窗: From first dose to 100 days post last dose (Up to approximately 29 months)
imAEs are specific events that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis). AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs)
时间窗: From first dose to 30 days post last dose (Up to approximately 27 months)
Drug related AEs are those events with relationship to study drug. If the relationship to study drug is missing, the AE will be considered as drug-related. The select AEs of interest are the following: Pulmonary, Renal, Gastrointestinal, Hepatic, Skin, Endocrine, and hypersensitivity/infusion reaction events. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death
次要结局
- Duration of Response (DoR)(From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months))
- Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L)(From baseline and up to subsequent survival follow-up visit 18 (Up to approximately 67 months))
- Overall Survival (OS)(From first dosing date to the date of death (Up to approximately 67 months))
- Objective Response Rate (ORR)(From first dosing date up to approximately 67 months)
- Progression Free Survival (PFS)(From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months))