EUCTR2017-004048-38-IT进行中（未招募）1 期
A phase II study of Avelumab in combination with Axitinib in patients with advanced Thymic epithelial tumours (TET) - CAVEATT
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
- 33
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
- •Histologically confirmed advanced Thymoma B3 or Thymic carcinoma
- •Inoperable per local Investigator (Masaoka Stage IIIb or IV).
- •Progression after treatment with least one platinum containing chemotherapy regimen
- •Measurable disease (RECIST 1.1).
- •Age =18 years.
- •ECOG PS <2.
- •Adequate bone marrow function and organ function:
- •Hematopoietic function: total white blood cell count (WBC) = 3000/mm³, absolute neutrophil count (ANC) = = 1.5 × 109/L, platelet count = 100 × 109/L , hemoglobin = 9 g/dL
- •Hepatic function: 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).
- •Estimated creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula
- •Negative serum or urine pregnancy test at screening for women of childbearing potential
- •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 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Medical illness that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy, including
- •Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, transient ischemic attack, deep vein thrombosis or symptomatic pulmonary embolism (< 6 months prior to enrolment), congestive heart failure (= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
- •Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
- •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
- •-Active infection requiring systemic therapy;
- •-Patients with a history of non-infectious pneumonitis that has required a course of oral or intravenous steroids, or interstitial lung disease or pulmonary fibrosis
- •-inflammatory bowel disease
- •Patients with untreated central nervous system disease. Patients with controlled treated CNS lesions who have undergone surgery or stereotactic radiosurgery and stable for 4 weeks are eligible
- •Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent, in particular, any autoimmune syndrome typically associated with thymomas (myasthenia gravis, pure red cell aplasia), including patients with positive anti-AChR and/or anti-MuSK antibodies without clinical signs or symptoms of myasthenia gravis. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible
- •History of a hematologic or primary solid tumor malignancy, unless in remission for at least 2 years. Patients with pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanomatous skin cancer or carcinoma in situ of the cervix are eligible
- •Significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea or inability to swallow oral medications.
- •Prior organ transplantation including allogenic stem-cell transplantation.
- •Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines
- •Serious psychiatric or medical conditions that could interfere with treatment.
- •Concurrent therapy with approved or investigational anticancer therapeutics.
- •Current use of immunosuppressive medication within 7 days prior to start treatment, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- •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)
研究者
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