EUCTR2016-001256-22-HU进行中（未招募）1 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Determine the Safety and Efficacy of GL-0817 (with Cyclophosphamide) for the Prevention of Recurrence in HLA-A2+ Patients with High-Risk Squamous Cell Carcinoma of the Oral Cavity
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Gliknik Inc
- 入组人数
- 228
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
- •1.Age = 18 years
- •2.Histologic diagnosis of squamous cell carcinoma of the oral cavity including the lip, floor of mouth, anterior 2/3 of tongue, alveolus and gingiva, buccal mucosa, hard palate and retromolar trigone
- •3.Patients must have undergone primary gross total resection (no re-resected patients are allowed) with fulfillment of at least 1 of the following histologic criteria for high-risk disease:
- •Histologic involvement of 2 or more regional lymph nodes
- •Any lymph node with histologic extracapsular extension (ECS)
- •Close (<3mm) or positive surgical margins on microscopic evaluation with no gross residual tumor
- •4.No evidence of locoregional disease or distant metastases at screening. Subjects must have negative scans (CT, CT-PET or MRI) for locoregional recurrence, brain or lung metastases. A negative biopsy will be mandated in patients with a positive scan. Other evaluations should be performed as clinically indicated.
- •5.No history of distant metastases.
- •6.Tumor tissue from surgery or biopsy must be available to determine MAGE-A3 expression for correlative studies.
- •7.Following surgery, the patient must have received external beam radiotherapy (58-66 Gy in 2 Gy fractions, 5 days per week) with concomitant cisplatin starting within 8 weeks of surgery. A brief delay in the initiation of radiotherapy following 8 weeks post-surgery due to administrative reasons (e.g., start of RT on Mondays) may be permitted by the Medical Monitor. The cumulative dose of cisplatin the subject received must be = 150 mg/m2. Protocol therapy must be initiated within a period of 4-8 weeks (28-56 days) following the end of RT.
- •8.The patient is, in the investigator’s opinion, adequately recovered from the effects of surgery and chemoradiotherapy to participate in this study.
- •9.Blood HLA-A2 phenotype
- •10.ECOG Performance Status = 1
- •11.Laboratory values obtained = 14 days prior to randomization:
- •Absolute neutrophil count (ANC) = 1500/µL (without intervention, e.g., G-CSF)
- •Platelets = 75,000/µL (without intervention, e.g., transfusion)
- •Hemoglobin = 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb =8.0 g/dl is acceptable).
- •Alkaline phosphatase = 2.5 x upper limit of normal (ULN)
- •AST and ALT = 2 x ULN
- •Creatinine < 2 x ULN
- •Bilirubin < 1.5x ULN (except for patients with Gilbert’s disease, for whom the upper acceptable limit of serum bilirubin is 3mg/dL)
- •12.A female subject is eligible to enter the study if she is:
- •not pregnant or nursing; Female participants must not breastfeed during the study and for a period of 30 days following the last dose.
- •of non-childbearing potential (i.e., women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or
- •of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to one of the following:
- •-complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent and 6 months after the last dose of study agent; or
- •-consistent and correct use of 1 of the following highly effective methods of birth
排除标准
- •1.Known HIV or hepatitis B/C infection (testing not required). Subjects who are hepatitis C antibody positive may be enrolled if they are confirmed to have a negative viral load at screening.
- •2.Subjects with active autoimmune disease or a history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment.
- •3.Subjects who have used systemic corticosteroids or other immunosuppressants for any condition within 14 days of randomization. Inhaled or topical steroids are permitted.
- •4.Any medical condition which would, in the investigator’s opinion, compromise the patient’s ability to mount an immune response, renders the patient a poor candidate for this trial or could confound the results of the study
- •5.Major surgery or traumatic injury within 28 days of randomization
- •6.Prior splenectomy or organ allograft
- •7.Any other prior, concurrent or planned chemotherapy, immunotherapy, radiotherapy, device, or investigational therapy for this cancer other than those specified in this study.
- •8.History of other malignancy (i.e., excluding disease under study) within 3 years of randomization. Exceptions include: adequately-treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated non-metastatic prostate cancer.
- •9.Known hypersensitivity to GM-CSF, yeast-derived products or any component of the GM-CSF drug product (e.g., mannitol) or poly-ICLC (e.g., carboxymethylcellulose).
- •10.Known hypersensitivity to cyclophosphamide, its metabolites or any other components, or known urinary outflow obstruction.
研究者
相似试验
进行中（未招募）
1 期
A Phase 2 Study to Evaluate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 In Duchenne Muscular DystrophyEUCTR2014-002072-92-ITPfizer Inc. 235 East 42nd Street, New York, NY 10017105
招募中
1 期
A Randomized, Double-Blind, Placebo-Controlled Study of NIDO-361 in Patients with SBMASpinal and Bulbar Muscular AtrophyMedDRA version: 20.0Level: LLTClassification code: 10068600Term: Kennedy's disease Class: 10010331CTIS2023-507128-22-00ido Biosciences Inc.54
进行中（未招募）
1 期
Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)MedDRA version: 20.0Level: PTClassification code 10077380Term: Epileptic encephalopathySystem Organ Class: 10029205 - Nervous system disordersEUCTR2020-003140-83-NLeurocrine Biosciences, Inc.60
进行中（未招募）
1 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's DiseaseCrohn's DiseaseEUCTR2017-001976-48-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO240
进行中（未招募）
不适用
This is a clinical research study involving an experimental drug named GS-6624 for the treatment of metastatic colorectal adenocarcinoma, a sub-type of cancer of the colon and/or rectum. The purpose of this study is to test the effectiveness and safety of GS-6624 at different dose levels when it is given with FOLFIRI. We want to find out what effects, good and/or bad, GS-6624 has on you and your metastatic colorectal adenocarcinoma when it is given with FOLFIRI.EUCTR2011-003754-61-ESGilead Sciences, Inc.265