EUCTR2018-000096-32-BE进行中（未招募）1 期
Metro-PD1: a phase I/II trial evaluating anti-PD1 (Nivolumab) incombination with metronomic chemotherapy in children and teenagerswith refractory /relapsing solid tumors - METRO-PD1
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
- 102
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 proven diagnosis of solid malignant tumor. Confirmed progressive or refractory disease despite standard therapy or for which no effective standard therapy exists.
- •-Histologically proven diagnosis of:
- •embryonal brain tumor,
- •ependymoma,
- •low-grade glioma (LGG),
- •high-grade glioma (HGG) except diffuse Intrinsic Pontine glioma
- •(DIPG), Supratentorial Diffuse Midline Glioma K27M mutated are eligible,
- •rhabdomyosarcoma,
- •neuroblastoma,
- •Ewing sarcoma,
- •and other solid tumors and after approval from coordinators (except
- •DIPG, osteosarcoma, lymphoma),
- •and confirmed progressive or refractory disease despite standard
- •therapy or for which no effective standard therapy exists (this criterion is applicable to stage 2 only)
- •- Male and female subjects < 18 years of age at inclusion;
- •patients 18 years and older may be included after discussion with the
- •sponsor if they had a pediatric recurrent/refractory malignancy
- •diagnosed before the age of 18.
- •- Evaluable or measurable disease as defined by adequate standard
- •imaging criteria for each patient's tumor type (see corresponding
- •appendices for definition of evaluable and/or measurable lesions):
- •RANO criteria for patients with high grade glioma
- •RAPNO criteria for patients with low grade glioma
- •WHO for other cerebral tumors
- •INRC criteria for patients with neuroblastoma (NB),
- •RECIST v1.1 for tumors other than cerebral tumors and neuroblastoma
- •- Performance status: Karnofsky performance status (for patients >16
- •years of age) or Lansky Play score (for patients =16 years of age) =
- •- Life expectancy = 3 months
- •- Adequate organ function:
- •-Hematologic criteria
- •Peripheral absolute neutrophil count (ANC) = 1500/mm3
- •(unsupported)
- •White blood cells count = 2500/mm3
- •Platelet count = 100,000/mm3 (unsupported)
- •Hemoglobin = 8.0 g/dL (transfusion is allowed)
- •-Cardiac function
- •Shortening fraction (SF) >29% and left ventricular ejection fraction
- •(LVEF) =50% at baseline, as determined by echocardiography
- •(mandatory only for patients who have received cardiotoxic therapy).
- •Absence of QTc prolongation (QTc > 450 msec on baseline ECG, using the Fridericia correction [QTcF formula]) or other clinically significant ventricular or atrial arrhythmia.
- •-Renal and hepatic function
- •Serum creatinine < 1.5 x upper limit of normal (ULN) for age
- •Total bilirubin < 1.5 x ULN,
- •Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) < 3 x ULN;
- •-aspartate aminotransferase (AST)/serum glutamic oxaloacetic
- •transaminase/SGOT < 3 x ULN
- •- Able to comply with scheduled follow-up and with management of
- •- Females of child bearing potential must have a negative urine
- •pregnancy test within seven days prior to initiation of treatment.
- 另有 6 项未显示
排除标准
- •- Leukemia
- •- Diagnosis of lymphoma, diffuse intrinsic pontine glioma or
- •osteosarcoma (for stage 2 only)
- •- Patients with symptomatic central nervous system (CNS) metastases
- •who are neurologically unstable or require increasing doses of
- •corticosteroids or local CNS directed therapy to control their CNS disease.
- •- Patients requiring high doses of corticosteroids >0.25mg/kg
- •prednisolone or equivalent) or increasing doses of corticosteroids during the seven days prior to receiving study drug.
- •- For patients with CNS tumor:
- •Evidence of > Grade 1 recent CNS hemorrhage on the baseline MRI
- •Participants with bulky tumor on imaging are ineligible; bulky tumor is defined as:
- •i) Tumor with any evidence of uncal herniation or severe midline shift
- •ii) Tumor with diameter of > 6 cm in one dimension on contrastenhanced MRI
- •iii) Tumor that in the opinion of the investigator, shows significant mass effect
- •- Impairment of gastrointestinal (GI) function or GI disease that may
- •significantly alter drug absorption of oral drugs (e.g., ulcerative
- •diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption
- •- Clinically significant, uncontrolled heart disease (including history of
- •any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal
- •arrhythmias, or conduction abnormality within twelve months of
- •- Known active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
- •- Active autoimmune disease requiring immunosuppressive treatment
- •- Known congenital immunodeficiency
- •- Presence of any NCI-CTCAE v5 grade = 2 treatment-related extrahematological toxicity with the exception of alopecia, ototoxicity or peripheral neuropathy.
- •- Systemic anticancer therapy within 21 days of the first study dose or 5 times its half-life, whichever is less, 6 weeks in case of nitrosourea.
- •- No clinical benefit with previous antiPD1 or antiPDL1 treatment (SD
- •during a period inferior to 6 months, or PD).
- •- Previous myeloablative therapy with autologous hematopoietic stem cell rescue within 8 weeks of the first study drug dose.
- •- Allogeneic stem cell transplant within 3 months prior to the first study drug dose.
- •- Patients receiving any agent to treat or prevent graft-versus host
- •disease (GVHD) post bone marrow transplant are not eligible for this
- •- Radiotherapy (non-palliative) within 21 days prior to the first dose of drug (or within six weeks for therapeutic doses of MIBG or craniospinal irradiation).
- •- Major surgery within 21 days of the first dose. Gastrostomy, ventriculoperitoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48 hour interval must be maintained before the first dose of the investigational drug is administered.
- •- Currently taking medications with a known risk of prolonging the QT
- •interval or inducing Torsades de Pointes.
- •- Known hypersensitivity to any study drug or component of the
- •formulation.
- •- Absence of effective contraception in patients of childbearing age
- •- Pregnant or nursing (lactating) females.
- •- Vaccination with live, attenuated vaccines within 4 weeks of the first dose of the study drugs except inactivated vaccines.
- •- Patients with a known complete absence of DPD activity, it is known
- •that patients carrying some homozygous or heterozygous mutations of DPYD responsible for the complete or almost complete absence of
研究者
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