EUCTR2015-003091-77-NL进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Open-Label Study of Avelumab (MSB0010718C) Alone or in Combination with Pegylated Liposomal Doxorubicin versus Pegylated Liposomal Doxorubicin Alone to In Patients with Platinum-Resistant/Refractory Ovarian Cancer - JAVELIN OVARIAN 200
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
- 550
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. Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with
- •highgrade serous component.
- •2. Platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory), respectively.
- •3. Received up to 3 lines of systemic anticancer therapy for platinum-sensitive disease, most recently platinum-containing, and no prior systemic therapy for platinum-resistant disease.
- •4. Measurable disease by investigator assessment with at least 1 unidimensional measurable lesion by RECIST v.1.1 that has not previously been irradiated.
- •5. At least 18 years of age (=20 years of age in Japan).
- •6. ECOG performance status (PS) 0 to 1.
- •7. Estimated life expectancy of at least 3 months.
- •8. Mandatory tumor biopsy must be performed prior to enrollment for all
- •patients (unless there is a documented clinical contraindication). In
- •addition, availability of archived FFPE tumor tissue should be confirmed.
- •If a patient underwent tumor tissue collection within 3 months prior to
- •enrollment with no intervening treatment, and the sample is provided,
- •then a new de novo tumor biopsy is not required.
- •9. Adequate bone marrow function, including:
- •a. Absolute neutrophil count (ANC) =1.5 x 10 to the power 9/L;
- •b. Platelet count =100 x 10 to the power 9/L;
- •c. Hemoglobin =9 g/dL (may have been blood transfused).
- •10. Adequate liver function, including:
- •a. Total bilirubin level =1.5 × the upper limit of normal (ULN).
- •b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 x ULN.
- •11. Adequate renal function as evidenced by:
- •a. Creatinine clearance =50 mL/min as calculated using the Cockcroft-Gault equation.
- •12. Serum/urine pregnancy test (for females of childbearing potential) negative at screening.
- •13. Female patients, of childbearing potential and at risk for pregnancy must agree to use two highly effective methods of contraception throughout the study and after the last dose of assigned treatment for the following lengths of time.
- •a. Patients who receive avelumab only: for at least 60 days after the last avelumab dose.
- •b. Patients who receive PLD (alone or in combination with avelumab): for at least 6 months after the last PLD dose.
- •14. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •15. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- •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 275
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 275
排除标准
- •1. Non-epithelial tumor, or ovarian tumors with low malignant potential (ie, borderline tumors).
- •2. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T 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).
- •3. Patients with PLD-resistant EOC, as evidenced by lack of response or progression within 6 months of the last dose of PLD.
- •4. Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks prior to study entry and are neurologically stable.
- •5. Concurrent anticancer treatment within 28 days prior to study entry, eg, cytoreductive therapy, radiotherapy [with the exception of palliative radiotherapy], immunotherapy, or cytokine therapy (except for erythropoietin); major surgery within 28 days prior to study entry (excluding diagnostic biopsy); use of hormonal agents within 7 days prior to study entry; or use of any investigational drug within 28 days prior to study entry. Note: patients receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days prior to study entry.
- •6. Diagnosis of any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.
- •7. Any one of the following currently or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de Pointes, arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation, bradycardia defined as <50 bpm), right bundle branch block and left anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association Class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
- •8. Ongoing cardiac dysrhythmias of NCI CTCAE Grade =3, atrial fibrillation of any grade, or QTcF interval >470 msec at screening (average of triplicate ECG).
- •9. Left ventricular ejection fraction (LVEF) <50% by MUGA or 2-D echocardiography.
- •10. Prior anthracycline-related cardiotoxicity or prior anthracycline exposure approaching the lifetime limit.
- •11. Prior organ transplantation including allogeneic stem-cell transplantation.
- •12. Known history of a positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
- •13. Active infection requiring systemic therapy.
- •14. 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).
- •15. Administration of a live vaccine within 30 days prior to study entry.
- •16. Current or prior use of immunosuppressive medication within 7 days prior to randomization. The following are exceptions to this exclusion criterion:
- •a. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection);
- •b. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent;
- •c. Steroids as premedication for
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