EUCTR2019-000572-41-BE进行中（未招募）1 期
An open label phase II study combining Nivolumab and Celecoxibin patients with advanced « cold » solid tumors - NICE-COMBO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
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
- •1. Men and women = 18 years of age.
- •2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- •3. Measurable disease as per RECIST 1.1.
- •4. Adequate renal, hepatic and hematologic functions as defined by laboratory parameters within = 7 days before treatment initiation.
- •- Platelet count =100x103/µL
- •- Leukocyte count = 3x103/µL
- •- Hemoglobin = 9 g/dL
- •- ASAT and ALAT = 2xULN
- •- Serum creatinine =1.5xULN
- •- Total bilirubin = 1.5xULN
- •- LDH = 1.5xULN
- •5. Viral serology : negative antibodies for HCV and HIV; negative antigens for HBV
- •6. Metastases biopsiable on two occasions
- •7. Patients should agree to perform biopsies and blood collections for translational research
- •8. Recently acquired (within 90 days prior to treatment) tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. In order to include only IDO positive (=5% expression of tumor cells) and non T-cell infiltrated tumors (<1% T cells infiltrating
- •the tumor bed).
- •9. Signed informed consent from the patient or legal representative must be obtained.
- •10. Cancer types with an indication of treatment with anti-PD1 antibodies such as
- •- Melanoma non BRAF mutated in first line
- •- Melanoma BRAF mutated in first or second line
- •- Lung cancer (NSCLC) in second line of treatment
- •- Renal cell Cancer (RCC) in second line
- •- Head and Neck squamous carcinoma (HNSC) after platinum salt based chemotherapy
- •- Bladder cancer after platinum salt based chemotherapy
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1. Active brain metastases or leptomeningeal metastases.
- •2. Ocular melanoma
- •3. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic treatment, or conditions not expected to
- •recur in the absence of an external trigger are permitted to enroll.
- •4. Clinically significant cardiovascular disease (including cardiac insufficiency NYHA grade III and IV, unstable angina, arrythmia, myocardial infarction, symptomatic congestive heart failure) in the past 12 months before enrollment
- •5. Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders or other conditions requiring concurrent medications not allowed during this study
- •6. Concomitant chemotherapy or radiotherapy for curative intent.
- •7. Administration of anti-angiogenic drugs or immunomodulatory agents.
- •8. Pregnancy or breast-feeding or planning to become pregnant within 6 months after the end of treatment.
- •9. Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months after the end of treatment.
研究者
相似试验
进行中（未招募）
1 期
A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid TumorsEUCTR2013-002844-10-FIBristol-Myers Squibb International Corporation1,620
进行中（未招募）
1 期
A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid TumorsAdvanced or metastatic solid tumors:1) Triple Negative Breast Cancer (TNBC)2) Gastric Cancer (GC)3) Pancreatic Cancer (PC)4) Small Cell Lung Cancer (SCLC).5) Bladder Cancer (BC)6) Ovarian Cancer (OC)MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-002844-10-DEBristol-Myers Squibb International Corporation1,620
进行中（未招募）
1 期
A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid TumorsAdvanced or metastatic solid tumors:1) Triple Negative Breast Cancer (TNBC)2) Gastric Cancer (GC)3) Pancreatic Cancer (PC)4) Small Cell Lung Cancer (SCLC).MedDRA version: 14.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-002844-10-ITBristol-Myers Squibb International Corporation200
进行中（未招募）
不适用
A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid TumorsEUCTR2013-002844-10-ESBristol-Myers Squibb International Corporation200
进行中（未招募）
1 期
A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab combined with Ipilimumab in Subjects with Advanced or Metastatic Solid TumorsAdvanced or metastatic solid tumors: 1) Triple Negative Breast Cancer (TNBC) 2) Gastric Cancer (GC) 3) Pancreatic Cancer (PC) 4) Small Cell Lung Cancer (SCLC). 5) Bladder Cancer (BC) 6) Ovarian Cancer (OC)MedDRA version: 21.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0 Level: LLT Classification code 10033604 Term: Pancreatic cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-002844-10-GBBristol-Myers Squibb International Corporation1,620