EUCTR2015-004117-24-FR进行中（未招募）1 期
A Phase II Safety Trial of Nivolumab in Patients with Metastatic Renal Cell Carcinoma Who Have Progressed During or After Prior Systemic Anti-Angiogenic Regimen - NIVORE
ICANCER0 个研究点目标入组 300 人开始时间: 2016年2月23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
- 300
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. Adult men and women = 18 years.
- •2. Patients with a histologically confirmed Renal Cell Carcinoma with a clear-cell component
- •3. Patients with metastatic (AJCC stage IV) Renal Cell Carcinoma, with at least one measurable lesion by CT Scan or MRI according to RECIST 1.1 or with clinically apparent disease that can be reliably monitored by the investigator.
- •4. Patients having received at least one prior systemic anti-angiogenic treatment including but not limited to: sunitinib, sorafenib, pazopanib, axitinib, and bevacizumab, in the advanced or metastatic setting. Prior cytokine therapies (e.g. IL-2, IFN-a), vaccine therapy or treatment with cytotoxics are allowed. Patients intolerant to prior systemic anti-angiogenic treatment can also be eligible (except hypersensitivity to other monoclonal antibodies).
- •5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status =2.
- •6. Favorable, intermediate or poor risk group patients measured by the IMDC model (Appendix 2).
- •7. Patients with small brain metastases will be eligible if they are: asymptomatic, without edema, not on corticosteroids, not be eligible for radiation therapy/surgery and not receiving active treatments.
- •8. Patients who have progressed following radiation therapy. Palliative, focal radiation therapy, and immunosuppressive doses of systemic corticosteroids must be discontinued at least 2 weeks prior to the first nivolumab administration.
- •9. Potentially reproductive patients must agree to use an effective contraceptive method or practice adequate methods of birth control or practice complete abstinence while on treatment, and for at least 31 weeks (˜ 7 months) for males and 23 weeks (˜ 5 months) for females after the last dose of study drug. Azoospermic males and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements.
- •10. Women of childbearing potential must have a negative serum pregnancy test done within 24 hours prior to the first dosing.
- •11. Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose.
- •12. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
- •13. Patients with social insurance coverage.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1. Patients with any active autoimmune disease or a history of known autoimmune disease (Patients with type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are however eligible for this trial).
- •2. Patients with uncontrolled adrenal insufficiency.
- •3. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- •4. Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
- •5. Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •6. Patients having received any non-oncology vaccine therapy used for prevention of infectious diseases including seasonal (influenza) vaccinations within 4 weeks of the first dose of study drug.
- •7. Patients receiving anti-cancer therapies must be discontinued at least 4 weeks prior to administration of study drug. Palliative, focal radiation therapy, and immunosuppressive doses of systemic corticosteroids must be discontinued at least 2 weeks before administration of study drug. All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug.
- •8. Patients with other prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast.
- •9. Patients with altered hematopoietic or organ function, as indicated by the following criteria (assessed within -14 to 3 days prior the first dosing):
- •WBC < 2000/µL
- •Polynuclear neutrophils < 1.5 x 109/L
- •Platelets < 100 x 109/L
- •Hemoglobin < 8.0 g/mL
- •ALAT/ASAT > 3.0 x ULN in the absence of or > 5x ULN in the presence of liver metastases
- •Bilirubin > 1.5 x ULN (except Gilbert Syndrome : < 3.0 mg/dL)
- •Creatinine clearance = 40 mL/min (measured or calculated by Cockroft and Gault formula) or serum creatinine > 2.0 x ULN
- •10. Patients with a history of hypersensitivity to other monoclonal antibodies or to the active or inactive excipients of study drug.
- •11. Known drug or alcohol abuse.
- •12. Known or underlying medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator’s opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or adverse events.
- •13. History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.
- •14. Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study.
- •15. Individuals deprived of liberty or placed under the authority of a tutor.
- •16. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment a
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