CANVAS: A Randomized Trial of Cvac (Autologous Dendritic Cells Pulsed with Recombinant Human Fusion Protein [Mucin 1-Glutathione S Transferase] Coupled to Oxidized Polymannose) as Maintenance Treatment in Patients with Epithelial Ovarian Cancer (EOC) in Second Remission

Prima BioMed0 个研究点目标入组 210 人开始时间: 2012年5月25日最近更新: 2017年1月9日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Prima BioMed
入组人数: 210

研究概览入排标准研究者记录与标识符相似试验

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

•Patients may be enrolled in and randomized to the study only if they meet all of the following criteria at screening and the baseline visit (defined as the visit within 2 weeks of the first dose):
•1. Females = 18 years of age at screening with a confirmed diagnosis of epithelial ovarian, fallopian tube, or peritoneal cancer
•2. Underwent standard cytoreductive surgery and first-line chemotherapy containing platinum before first relapse and were in complete remission for at least 6 months prior to relapse
•3. Relapsed once and then underwent standard platinum-based second line chemotherapy (at least 3 cycles is required) with or without a second bulk-reducing surgery
•4. Second remission defined as:
•a. No definitive evidence of disease (NED) on CT or MRI of the abdomen and pelvis;
•b. CA-125 = upper limit of normal (ULN) or 90% reduction in CA-125 since start of second-line chemotherapy;
•c. Negative physical exam (i.e., no clinical signs)
•5. Life expectancy = 3 months in the opinion of the investigator
•6. Signed an informed consent form (ICF)
•7. Willing and able to complete study procedures within the expected study timelines
•8. Mucin 1-positive tumor as determined by central immunohistopathology
•9. Histologically documented EOC, fallopian tube, or peritoneal cancer (patients with pseudomyxoma, mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, i.e., patients with low malignant potential tumors, and with clear cell or mucinous histology are excluded)
•10. Adequate end-organ and hematological function as defined by:
•a. Adequate bone marrow function: white blood cells (WBCs) = 3.0 K/µL, absolute neutrophil count (ANC) = 1.5 × 109/L, hemoglobin = 9 g/dL, and platelets = 100 × 109/L
•b. Adequate renal function: serum creatinine = 1.5 × ULN
•c. Adequate liver function: serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) = 2 × ULN and serum bilirubin = 1.5 × ULN
•11. Generally well-controlled blood pressure with systolic blood pressure = 140 mmHg and diastolic blood pressure = 90 mmHg prior to randomization (antihypertensive medications are permitted). Low-dose chronic hormonal or steroidal treatments are also permitted.
•12. Not pregnant, and if of childbearing potential, agrees to use a highly effective method of birth control (implanted, injectable, or oral combination hormonal method alone or in possible combinations, intrauterine device, vasectomized partner, or abstinence) prior to study entry, for the duration of the study, and for 3 months after the last dose of study agent. Male partners of a study patient must use a condom in addition to the acceptable method of contraception for the female partner as specified above
•13. ECOG status of 0 or 1 (applicable at the baseline visit only).
•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 189
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 21

排除标准

•Patients are to be excluded from the study at the time of screening and the baseline visit (defined as the visit within 2 weeks of the first dose) for any of the following reasons:
•1. More than 2 previous lines of chemotherapy for EOC, fallopian tube, or peritoneal cancer
•2. Primary platinum-refractory or platinum-resistant disease (i.e., patients who progress prior to cessation of induction therapy [platinum refractory] or recur within 6 months after cessation [platinum resistant])
•3. Treatment with any investigational product (for any condition) within 4 weeks of screening. Enrolled in or has not completed at least 28 days (prior to screening) since ending another investigational device or drug treatment, or currently receiving other investigational treatments
•4. Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose
•5. Evidence of severe or uncontrolled cardiac disease, including myocardial infarction or unstable angina within 6 months of screening, congestive heart failure, or ventricular arrhythmias requiring medication
•6. Diagnosed immunodeficiency or autoimmune disorder
•7. Infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV), or active and infectious hepatitis B virus (HBV) infection
•8. Pregnant or lactating/breastfeeding
•9. Evidence or history of central nervous system metastasis
•10. Known hypersensitivity to any of the components of the study agent
•11. Any unresolved persistent toxicities from prior systemic therapy that are either Grade 3 or Grade 4 (except alopecia) per the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
•12. Intent to treat patient with both an anti-angiogenesis therapy (such as bevacizumab) and a PARP inhibitor as part of maintenance therapy. Only one or the other are permitted while the patient is on study and must be started between the baseline visit and Visit 1 if it will be used as part of the patient’s maintenance therapy regimen
•13. Prior malignant diseases, unless the patient has been in full remission for a minimum of 2 years, except carcinoma in situ of the cervix or basal cell and squamous cell carcinomas of the skin (note: rationale for contraindication for existing and prior malignant diseases unless the patient has been in complete remission for an entire 2 years unless exceptions for in situ carcinoma or the cervix or basal cell or squamous cell carcinoma or the skins is provided in the investigator’s brochure)
•14. Active, uncontrolled, ongoing infection.

研究者

发起方

Prima BioMed

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