EUCTR2018-003521-28-FR进行中（未招募）1 期
Cryotherapy under interventional radiology combined with in situ ipilimumab and a flat dose of Nivolumab in stage IIIB/C melanoma. Prospective proof of concept study. - CRIRI
Hôpitaux Universitaires de Strasbourg0 个研究点目标入组 15 人开始时间: 2018年10月26日最近更新:
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
- 15
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
入选标准
- •1.Subject over 18 years old with stage IIIB/IIIC melanoma with lymph node metastases, with at least one =1 cm3 that is accessible to cryotherapy under interventional radiology (IR), assessed at the inclusion visit (V1).
- •2.ECOG performance status (0 to 2) at the selection visit (V0)
- •3.Woman or man of reproductive age with no desire to procreate for the duration of their participation in the study, agreeing to use dual-method contraception, with at least one barrier method, and for 5 months after the final infusion of Nivolumab for women and 7 months for men
- •4.Leukocytes >2000/mm3, neutrophils >1500/mm3, platelets >100,000/mm3, haemoglobin >9g/dl at the selection visit (V0)
- •5.Total bilirubin <1.5 mg/dl except for patients with Gilbert’s syndrome who may have total bilirubin <3.0 mg/dl at the selection visit (V0)
- •6.Liver function: SGOT, SGPT <2.5 N, if liver metastases SGOT and SGPT <5 N at the selection visit (V0)
- •7.Serum creatinine <1.5 N or creatinine clearance >40 ml/min (using the Cockcroft-Gault equation) at the selection visit (V0)
- •8.Patient is covered by a medical insurance scheme
- •9.Patient able to read and speak French, and to sign and date an informed consent form for the study, including the translational research
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •10.Pregnancy (women of childbearing potential : positive blood pregnancy test at the selection visit (V0) ) andor breastfeeding
- •11.Subject under guardianship
- •12.History of hypersensitivity to ipilimumab, nivolumab or one of the excipients
- •13.History of severe hypersensitivity to a monoclonal antibody
- •14.History of positive tests for HIV or Acquired Immunodeficiency Syndrome (HIV assessed at the selection visit (V0))
- •15.Positive tests for HCV or HBV indicating an acute or chronic infection at the selection visit (V0)
- •16.Patient presenting with an active, known or suspected autoimmune disease. The following, however, may participate:
- •- patient with type 1 diabetes or hypothyroidism requiring substitute hormone therapy only;
- •- patient with psoriasis, vitiligo or alopecia;
- •- patient with conditions that are not known to reoccur without an exogenous triggering agent.
- •17.History of active neoplasia during the last 3 years with the exception of localised curable cancers considered to be cured, such as basal or squamous cell carcinomas, superficial bladder cancer and prostate, colon or breast carcinoma in situ.
- •18.Active systemic infection
- •19.Patient with a condition requiring systemic steroid treatment (at a dose >10 mg/prednisone equivalent or at unstable dose) or another immunosuppressant within/following 14 days of study drugs administration. Inhaled steroids and treatment for adrenal insufficiency, however, are permitted.
- •20.Contraindication for the cryotherapy procedure as assessed by the radiologist (due to tumour size or proximity to a vascular or nerve structure giving the procedure an unacceptable level of risk) at the inclusion visit (V1)
- •21.Clotting disorder that may interfere with the cryoablation, assessed at the selection visit (V0)
- •22.Contraindication for MRI with gadolinium-based contrast media
- •23.History of uveal melanoma
- •24.Patient having received prior treatment for their melanoma, in particular, patient previously treated with interferon fewer than 3 months ago or with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD-137 or anti-CTLA-4 antibody. Patients who have undergone primary melanoma surgery and the excision of in-transit metastases, as well as adjuvant therapy with
- •interferon if completed over 3 months ago are eligible.
- •25.Contraindication for general and/or local anaesthesia
- •26.Patient operated on under general anaesthesia, within the 4 weeks prior to the planned Nivolumab infusion.
- •27.Patient operated on epidural anaesthesia, within the 72 h prior to the planned Nivolumab infusion.
研究者
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