EUCTR2013-003645-42-DE进行中（未招募）1 期
A single arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects with Relapsed or Refractory Follicular Lymphoma (FL)Protocol Amendment Number 01, country-specific, version 1.0, dated 27-nov-2013Revised protocol 02, including amendment 03 - CheckMate 140, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 115
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
- •Grade 1, 2, or 3a FL without pathologic evidence of transformation.
- •Male and female, ages 18 and above, with relapsed or refractory FL
- •lymphoma after > or = 2 prior treatment lines; each of the 2 prior
- •treatment lines must include at least CD20 antibody and/or an alkylating
- •ECOG PS 0-1
- •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 86
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •Known central nervous system lymphoma.
- •History of interstitial lung disease
- •Subjects with active, known or suspected autoimmune disease.
- •Prior allogeneic stem cell transplant.
- •Prior autologous stem cell transplant = 12 weeks prior to first dose of
研究者
相似试验
进行中（未招募）
1 期
Study of Nivolumab in subjects with Relapsed or Refractory Follicular Lymphoma (FL)EUCTR2013-003645-42-GBBristol-Myers Squibb International Corporation115
进行中（未招募）
1 期
Study of Nivolumab in subjects with Relapsed or Refractory Follicular Lymphoma (FL)ymphoma. Non-HodgkinMedDRA version: 16.1Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003645-42-FRBristol-Myers Squibb International Corporation115
进行中（未招募）
1 期
Study of Nivolumab in subjects with Relapsed or Refractory Follicular Lymphoma (FL)ymphoma. Non-HodgkinMedDRA version: 20.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003645-42-BEBristol-Myers Squibb International Corporation115
进行中（未招募）
1 期
Study of Nivolumab in subjects with Relapsed or Refractory Follicular Lymphoma (FL)ymphoma. Non-HodgkinMedDRA version: 16.1Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003645-42-ESBristol-Myers Squibb International Corporation115
进行中（未招募）
1 期
Study of Nivolumab in subjects with Relapsed or Refractory Follicular Lymphoma (FL)EUCTR2013-003645-42-SEBristol-Myers Squibb International Corporation115