EUCTR2016-002322-37-FR进行中（未招募）1 期
TROPHIMMUN, a phase II trial of avelumab in chemo-resistant gestational trophoblastic neoplasias (GTN) - TROPHIMM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •-Woman older than 18 years
- •-Patients with gestational trophoblastic disease resistant to mono-chemotherapy (methotrexate and/or actinomycine-D) or polychemotherapy (such as EMA-CO; EMA-EP; BEP; … regimens).
- •-No limitation in the number of previous chemotherapy lines
- •-Patients with Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •-Archival tumor tissue available and assessable for planned analyses, or tumor lesion biopsy feasible
- •-Patients with adequate bone marrow function measured within 28 days prior to administration of study treatment as defined below
- •*Absolute granulocyte count = 1.5 x 10 9 /L
- •*Platelet count = 100 x 10 9 /L
- •* Haemoglobin = 9.0 g/dL (may have been blood transfused)
- •-Patients with adequate renal function :
- •* Calculated creatinine clearance = 30 ml/min according to the Cockcroft-Gault formula (or local institutional standard method)
- •-Patients with adequate hepatic function
- •*Serum bilirubin = 1.5 x UNL and AST/ALT = 2.5 X UNL (= 5 X UNL for patients with liver metastases)
- •- Patients must have a life expectancy = 16 weeks
- •-Confirmation by a gynecologist of non-childbearing status 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 29
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxicT lymphocyte-associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
- •-Illness, incompatible with avelumab, such as congestive heart failure; respiratory distress; liver failure; allergy.
- •-Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for = 5 years.
- •-All subjects with brain metastases, except those meeting the following criteria:
- •oBrain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment,
- •oNo ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable).
- •oSubjects with brain metastases must be either off steroids except a stable or decreasing dose of <10mg daily prednisone (or equivalent).
- •-Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug.
- •-Persistent toxicities (>=CTCAE grade 2) with the exception of alopecia and sensory neuropathy, caused by previous cancer therapy.
- •-Treatment with other investigational agents.
- •-Bowel occlusive syndrome or other gastro-intestinal disorder that does not allow oral medication such as malabsorption.
- •-Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011).
- •-Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
- •-Active infection requiring systemic therapy.
- •-Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive)
- •-Administration of a live vaccine within 30 days prior to study entry.
- •-Current or prior use of immunosuppressive medication within 7 days prior to start of study treatment. The following are exceptions to this exclusion criterion:
- •oIntranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection);
- •oSystemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent;
- •oSteroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
- •-Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
- •-Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control.
- •-Treatment with oral anticoagulant such Coumadin.
- •-Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome. Torsades de Pointes, arrhythmias (including sustained ventricular
研究者
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