EUCTR2018-000843-14-ES进行中（未招募）1 期
A phase II multicenter, open-label, single arm trial of avelumab in combination with pegylated liposomal doxorubicin in recurrent/metastatic endometrial cancer
GEICO (Grupo Español de Investigación en Cáncer de Ovario)0 个研究点目标入组 48 人开始时间: 2018年4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
- 48
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
- Female
入选标准
- •1.Be willing and able to provide written informed consent/assent for the trial.
- •2.Be at least 18 years of age on day of signing informed consent.
- •3.Have a histologically or cytologically-documented, advanced (metastatic and/or unresectable) endometrial carcinoma that is incurable. All epithelial endometrial histologies are eligible including: endometrioid, serous, clear-cell carcinoma or squamous. Sarcomas and mesenchymal tumors are excluded.
- •4.Received only 1 prior line of systemic platinum-based treatment based chemotherapy for advanced, recurrent or metastatic endometrial cancer.
- •5.Have measurable disease based on RECIST 1.1, (See Appendix 3)
- •6.Availability of fresh or archival FFPE tumor specimens for analysis for biomarker analysis from a tumor lesion not previously irradiated.
- •7.ECOG Performance Status (PS) 0 or 1.
- •8.Demonstrate adequate organ function as defined by the following criteria:
- •Hematologic: Absolute neutrophil count (ANC) = 1.5 × 109/L, platelet count = 100 × 109/L, and hemoglobin = 9 g/dL (without recent transfusion)
- •Hepatic: Total bilirubin level = 1.5 × the upper limit of normal (ULN) range and AST and ALT levels = 2.5 × ULN or AST and ALT levels = 5 x ULN (for subjects with documented metastatic disease to the liver).
- •Renal: Estimated creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
- •9.Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Patients of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 4.3.1 – Contraception, for the course of the study through 60 days after the last dose of study medication.
- •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 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •1.Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •2.Receipt of 2 or more prior chemotherapy regimens for advanced, recurrent, or metastatic endometrial cancer
- •3.History of Clinically significant: cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication.
- •4.Impaired cardiac function defined as left ventricular ejection fraction (LVEF) < 50 % (or below the study site’s lower limit of normal) as measured by MUGA or ECHO or planned concomitant use of potentially cardiotoxic medication.
- •5.Previous anthracycline-based chemotherapy.
- •6.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •7.Concurrent anticancer treatment within 28 days prior to study entry. 8.Has a known history of tuberculosis.
- •9.Prior organ transplantation including allogenic stem-cell transplantation.
- •10.Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade = 3
- •11.Known additional malignancy diagnosed within 5 years prior to registration. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- •12.Active central nervous system (CNS) metastases and/or carcinomatous meningitis. 13.Active infection requiring systemic therapy.
- •14.Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
- •15.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •16.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
- •17.Has previously participated in any other avelumab trial, or received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or any other immune-modulating mAb (including ipilimumab and any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •18.Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
- •19.Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
- •20.Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade = 2, or other Grade = 2 not constituting a safety risk based on investigator’s judgment are acceptable.
- •21.Has received a live vaccine within 4 weeks of planned start of study therapy.
- •22.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- •23.Other severe acute or chronic medical or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior, or l
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