A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipilimumab) and/or Opdivo (Nivolumab)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 10
- 主要终点
- Improvement in management of persistent grade 2 diarrhea as measured by proportion of responders to less than or equal to grade 1
研究概览
简要总结
The purpose of this study is to compare the effects of Infliximab and oral prednisone versus methylprednisolone and oral prednisone in patients with melanoma, lung cancer, or renal cell carcinoma who have immune related Grade 3-4 diarrhea for up to 3 days or persistent Grade 2 diarrhea for more than 5 days after treatment with Yervoy and/or Opdivo
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Subjects must have melanoma or lung cancer or renal cell carcinoma and received ipilimumab or nivolumab as a single treatment or in combination
- •Subject must have NCI common toxicity Grade 3-4 immune-related diarrhea for up to 3 days or persistent Grade 2 diarrhea for more than 5 days
- •Subjects must be discontinued from ipilimumab or nivolumab as monotherapy or with the combination regimen
排除标准
- •Subjects who received other anti Cytotoxic T-lymphocytic antigen (CTLA-4) (non-ipilimumab) or other anti-Programmed death-1 (PD-1) (non-nivolumab) treatment
- •Subjects treated with systemic Corticosteroid (CST) within 1 week before randomization and subjects treated with infliximab within 7 weeks before randomization
- •Subjects with known history of tuberculosis
- •Subjects with immunosuppressive disease that require use of systemic steroids or immunosuppressive treatment
- •Subjects allergic to infliximab, inactive components of infliximab, murine proteins and methylprednisolone
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Infliximab + Prednisone
Infliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days
干预措施: Infliximab + Prednisone (Drug)
Methylprednisolone + Prednisone
Methylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days
干预措施: Methylprednisolone + Prednisone (Drug)
结局指标
主要结局
Improvement in management of persistent grade 2 diarrhea as measured by proportion of responders to less than or equal to grade 1
时间窗: Up to 78 hours
Improvement in management of immune related grade 3 and 4 diarrhea as measured by proportion of responders to less than or equal to grade 1
时间窗: Up to 78 hours
次要结局
- Number of days to improvement to less than grade 1 diarrhea(Randomization up to 12 weeks)
- Number of patients with Gastrointestinal (GI) specific AEs(Up to 12 weeks)
- Number of hospitalizations(Up to 12 weeks)
- Number of patients with adverse events (AEs)(Up to 12 weeks)
- Quality of life as measured by European Quality of Life-5 Dimensions Questionnaire (EQ-5D)(Up to 12 weeks)
- Duration of hospitalizations(Up to 12 weeks)
- Number of patients with AEs related to steroid use(Up to 12 weeks)