EUCTR2012-001514-42-DE
进行中（未招募）
1 期
A Phase I-II Dose Escalation and Expansion Study to Investigate the Safety, Immunoregulatory Activity, Pharmacokinetics, and Preliminary Antitumor Activity of Anti-Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Advanced Hepatocellular Carcinoma in Subjects with or without Chronic Viral Hepatitis - Anti-PD-1 HCC
适应症Hepatocellular carcinomaMedDRA version: 19.1Level: LLTClassification code 10019829Term: Hepatocellular carcinoma recurrentSystem Organ Class: 100000004864MedDRA version: 19.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864MedDRA version: 19.1Level: LLTClassification code 10019830Term: Hepatocellular carcinoma resectableSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Hepatocellular carcinoma
- 发起方
- Bristol-Myers Squibb International Corporation
- 入组人数
- 570
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\-Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
- •\-Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •\-Dose Escalation Phase: Child\-Pugh score of 7 points or less. For all other cohorts Child\-Pugh score of 6 points or less.
- •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 342
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 228
- •\-Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
排除标准
- •\-History of autoimmune disease
- •\-Any prior or current clinically significant ascites
- •\-History of autoimmune disease
- •\-Any prior or current clinically significant ascites
- •\-History of autoimmune disease
- •\-Any prior or current clinically significant ascites
结局指标
主要结局
未指定
相似试验
进行中（未招募）
1 期
Study to evaluate the effectiveness, safety and tolerability of nivolumab in subjects with advanced liver cancer.Hepatocellular carcinomaMedDRA version: 20.0 Level: LLT Classification code 10019829 Term: Hepatocellular carcinoma recurrent System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10019830 Term: Hepatocellular carcinoma resectable System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2012-001514-42-GBBristol-Myers Squibb International Corporation570
进行中（未招募）
1 期
Clinical trial using GSK525762 in combination with fulvestrant in subjects with breast cancer.ER-positive Breast CancerMedDRA version: 20.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000115074Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2016-003074-40-FRGlaxoSmithKline Research & Development Limited123
进行中（未招募）
1 期
Study investigation GSK525762 in combination with fulvestrant in treatments of breast cancer.ER-positive Breast CancerMedDRA version: 19.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2016-003074-40-ESGlaxoSmithKline Research & Development Limited300
进行中（未招募）
1 期
Clinical trial using GSK525762 in combination with fulvestrant in subjects with breast cancer.ER-positive Breast CancerMedDRA version: 23.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2016-003074-40-GBGlaxoSmithKline Research & Development Limited300
尚未招募
1 期
A Study of the Combination of Talquetamab and Teclistamab in Participants with Relapsed or Refractory Multiple MyelomaJPRN-jRCT2031230640Fujikawa Ei164