EUCTR2018-002893-38-IT进行中（未招募）1 期
Phase II Study on NIVolumab in combination with FOLFOXIRI/Bevacizumab in first line chemotherapy of Advanced COloRectal cancer RASm/BRAFm patients - NIVACOR GOIRC-03-2018
GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)0 个研究点目标入组 70 人开始时间: 2020年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 years on day of signing informed consent.
- •Histologically confirmed metastatic CRC RAS/BRAF mutated.
- •Suitable for first line chemotherapy.
- •Life expectancy > 3 months.
- •At least one site of measurable disease per RECIST criteria.
- •Performance status of 0-1 on the ECOG Performance Scale.
- •Adequate organ function, all screening labs should be performed within 28 days of treatment initiation.
- •Availability of 1 tumor block at baseline.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Prior chemotherapy.
- •Systemic corticosteroids within 2 weeks of the first dose of nivolumab.
- •Diagnosis of immunodeficiency or patient who is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment.
- •Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- •Active and untreated brain (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are not using steroids for at least 7 days prior to trial treatment.
- •Evidence of interstitial lung disease, active non-infectious pneumonitis, or a history of grade 3 or greater pneumonitis.
- •Active infection requiring systemic therapy.
- •History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- •Live vaccine within 30 days prior to the first dose of trial treatment.
- •Women with a positive pregnancy test at enrollment or prior to administration of study medication.
研究者
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