EUCTR2017-001083-38-DE进行中（未招募）1 期
Combined treatment with Nivolumab and Trabectedin in patients with metastatic or inoperable soft tissue Sarcomas - The NiTraSarc Phase II Trial - NiTraSarc
niversitätsmedizin Greifswald0 个研究点目标入组 92 人开始时间: 2017年11月20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
- 92
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
- •1Patients must have histologically confirmed liposarcoma or leiomyosarcoma
- •1Patients must have histologically confirmed soft tissue sarcoma (STS) other than liposarcoma or leiomyosarcoma (excluding GIST)
- •Both Groups (A and B):
- •2= 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy (anthracycline-containing regimen)
- •3Signed Written Informed Consent
- •4Men and women aged = 18 years.
- •5Eastern Cooperative Oncology Group (ECOG) performance status = 1.
- •6Measurable disease (according to RECIST criteria version 1.1)
- •7Locally advanced/unresectable or metastatic disease
- •8No prior therapy with ipilimumab or nivolumab, or any agent targeting programmed cell death 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
- •9No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation = 28 days before study registration; no treatment with nitrosourea or mitomycin = 42 days before study registration
- •10Patients should have resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, version 4.0, grade 1 or less
- •11Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1 representative hematoxylin and eosin (H&E) and 20 unstained sarcoma tissue slides available for submission to central pathology review. If no archival tissue is available, a fresh biopsy has to be performed during screening.
- •12Absolute neutrophil count (ANC) = 1,500/mm3
- •13Platelet count = 100,000/mm3
- •14Creatine phosphokinase (CPK) =2,5 x ULN
- •15Creatinine = 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance = 60 mL/min (calculated by using the Cockcroft-Gault formula)
- •16Total bilirubin = upper limit of normal (ULN). If total bilirubin is greater than (>) ULN, measure indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal range, participant may be eligible).
- •17AST/ALT = 2.5 x upper limit of normal (ULN)
- •18AP = 2.5 x upper limit of normal (ULN)
- •19Hemoglobin = 9 g/dl. If hemoglobin <9 g/dl, blood transfusion is permitted. If hemoglobin cannot be enhanced to = 9 g/dl, patient cannot be included into the study.
- •20Thyroid stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH if free T4 is normal and patient is clinically euthyroid, patient is eligible
- •21Not pregnant and not nursing; for women of childbearing potential who are sexually active, a negative pregnancy test (urinary or serum beta-HCG) at screening (performed =7 days prior to registration) is required.
- •22Female participants must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (at the discretion of the investigator), or if sexually active, follow the contraceptive guidance in Appendix 4 throughout the duration of study treatment and for a minimum of 5 months after the last dose of study medication. Male participants must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm for a minimum of 7 months a
排除标准
- •1Prior exposure to trabectedin
- •2Active known or suspected autoimmune disease (e.g. autoimmune colitis, autoimmune panhypopituitarism, autoimmune adrenal insufficiency)
- •i) Subjects with vitiligo, type 1 diabetes mellitus, resolved childhood asthma or atopy are permitted to enroll.
- •ii) Subjects with suspected autoimmune thyroid disorders may be enrolled if they are currently euthyroid or with residual hypothyroidism requiring only hormone
- •replacement.
- •iii) Subjects with psoriasis requiring systemic therapy must be excluded from enrollment.
- •3Patients with human immunodeficiency virus (HIV) infection are excluded unless cluster of differentiation (CD)4+ cells are > 350 and no viral load is detectable
- •4 Symptomatic, untreated, or uncontrolled brain metastases present
- •5Known significant chronic liver disease, such as cirrhosis or active hepatitis B or C
- •oHepatitis B can be defined as (all of the following conditions must be met):
- •Hepatitis B surface antigen (HBsAg) > 6 months
- •Serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) >=2,000 IU/ml (10exp4 copies/ml)
- •Persistent or intermittent elevation in alanine aminotransferase (ALT)/alanine aminotransferase (AST) levels
- •Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
- •oHepatitis C can be defined as:
- •Hepatitis C antibody (Ab) positive
- •Presence of hepatitis C virus (HCV) ribonucleic acid (RNA)
- •6Known active pulmonary disease with hypoxia defined as:
- •oOxygen saturation < 85% on room air or
- •oOxygen saturation < 88% despite supplementaloxygen
- •7Systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration
- •8Myocardial infarct within 6 months before enrollment, New York Heart Association Class III or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
- •9Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, ongoing active infection, or psychiatric illness/social situation that may potentially impair the participant's compliance with study procedures
- •10Unwilling or unable to have a central venous catheter
- •11Known allergies, hypersensitivity, or intolerance to trabectedin, dexamethasone, or their excipients, or monoclonal antibodies (biologics) therapy
- •12Pregnant or breast-feeding
- •13Any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements
- •14On-treatment participation in another clinical study in the period 30 days prior to start of study treatment and during the study
- •15 History of allogeneic solid organ or tissue transplant including allogeneic hematopoetic stem cell transplantation.
研究者
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