NL-OMON52016
招募中
2 期
Prospective, randomized, neoadjuvant phase II study with combination immuno-oncology in primary clear cell renal cell cancer at risk for recurrence or distant metastases (NESCIO-trial; M21NSC; CA209-6DJ) - NESCIO
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 46 人待定
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- clear cell renal cell carcinoma
- 发起方
- Antoni van Leeuwenhoek Ziekenhuis
- 入组人数
- 46
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Adults at least 18 years of age
- •World Health Organization (WHO) Performance Status 0 or 1
- •Histologically confirmed resectable clear cell RCC (measurable according to
- •RECIST 1\.1\), that can be biopsied, and no history of distant metastases
- •Intermediate to high risk will be based on clinical TNM and biopsy nuclear
- •grade. These are:
- •1\. cT1b\-cT2a grade 4 cN0 cM0
- •2\. cT2b grade 3\-4 cN0 cM0
- •3\. cT3 any grade cN0 cM0
- •4\. cT4 any grade cN0 cM0
排除标准
- •Distantly metastasized RCC • Brain metastases (based on symptoms) • Non\-clear
- •cell RCC • No measurable lesion according to RECIST 1\.1 • Subjects with any
- •active autoimmune disease or a documented history of autoimmune disease, or
- •history of syndrome that required systemic steroids or immunosuppressive
- •medications, except for subjects with vitiligo or resolved childhood
- •asthma/atopy • Prior CTLA\-4 or PD\-1/PD\-L1 or LAG\-3 targeting immunotherapy •
- •Radiotherapy prior or post\-surgery • Patients will be excluded if they test
- •positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus
- •ribonucleic acid (HCV antibody), indicating acute or chronic infection; if
- •treated and being at least one year free from HCV patients are allowed to
结局指标
主要结局
未指定
相似试验
进行中（未招募）
1 期
Study in kidney cancer patients with at least the kidney tumor present and sometimes enlarged lymph nodes in the vicinity of the affected kidney, in which the subjects first receive an immunotherapy treatment, which may consist of either nivolumab alone, or the combination of nivolumab and ipilimumab, or the combination of nivolumab and relatlimab, after which the kidney tumor (and possibly enlarged lymph nodes) is removed.primary clear cell renal cell cancer at risk for recurrence or distant metastasesMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLGTClassification code 10038364Term: Renal and urinary tract neoplasms malignant and unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-002360-51-NLAntoni van Leeuwenhoek ziekenhuis69
进行中（未招募）
1 期
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast CancerER+/HER2- Breast CancerMedDRA version: 23.0Level: LLTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2019-001334-34-BEBristol-Myers Squibb International Corporation23
进行中（未招募）
1 期
A Study of Neoadjuvant Nivolumab + Abemaciclib or Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast CancerER+/HER2- Breast CancerMedDRA version: 21.1Level: PTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2019-001334-34-ESBristol-Myers Squibb International Corporation324
进行中（未招募）
1 期
A Study of Neoadjuvant Nivolumab + Abemaciclib or Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast CancerER+/HER2- Breast CancerMedDRA version: 21.1Level: PTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2019-001334-34-FRBristol-Myers Squibb International Corporation324
进行中（未招募）
1 期
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast CancerEUCTR2019-001334-34-DEBristol-Myers Squibb International Corporation168