EUCTR2018-003902-14-CY进行中（未招募）1 期
DKN-01/atezolizumab as second line treatment of biliarY tract cancer and in combiNAtion or not with paclitaxel as second line treatMent of esophagogastrIC cancer: a multi-center Phase II Trial - DYNAMIC
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 123 人开始时间: 2019年6月7日最近更新:
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
- 入组人数
- 123
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 metastatic or unresectable intra or extrahepatic cholangiocarcinoma or esophagogastric adenocarcinoma.
- •Measurable disease by CT/MRI (RECIST 1.1) within 28 days of enrollment (BTC)/randomization (EGC)
- •Male and female subjects of age =18 years
- •Performance status ECOG 0-1
- •Life expectancy = 4 months in the opinion of the investigator
- •Normal 12-lead ECG (patients with abnormal ECG will be eligible if changes are not considered clinically significant by the local investigator)
- •Adequate hematological function:
- •oHemoglobin = 9 g/dl (prior transfusions are allowed if they have been done = 7 days before testing the Hb)
- •oWhite blood cell (WBC) = 3.0 x 109/L
- •oAbsolute neutrophil count (ANC) = 1.5 x 109/L
- •oPlatelet count = 75 x 109/L
- •Adequate liver function:
- •oTotal bilirubin = 1.5 x upper limit of normal (ULN), except subjects with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN.
- •oALT, AST & alkaline phosphatase = 3 x ULN; = 5 x ULN in case of liver/bone metastases
- •oSerum albumin = 2.5 g/dL
- •Adequate renal function:
- •oEstimated glomerular filtration rate (eGFR) according to MDRD (see Appendix G) should be > 50 ml/min
- •Adequate coagulation:
- •oInternational Normalized Ratio (INR) or Prothrombin Time (PT): = 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or Partial Thromboplastin Time (PTT) is within therapeutic range of intended use of anticoagulants
- •The following local treatment modalities are allowed prior to enrollment/randomization within the rules described (provided there has been a full recovery):
- •oSurgery: patients may have undergone a non-curative operation (i.e., R2 resection [with macroscopic residual disease] or palliative bypass surgery only), performed at least 28 days before enrollment/randomization. Patients who have previously undergone curative surgery, must have evidence of non-resectable and measurable disease relapse requiring systemic chemotherapy prior to study entry.
- •oRadiotherapy: patients may have received prior radiotherapy (with or without radiosensitising low-dose chemotherapy) for localised disease. However, there must be clear evidence of disease progression post-treatment prior to inclusion in this study. The radiotherapy should have been finished at least 15 days prior to enrollment/randomization.
- •oPhotodynamic therapy (PDT) for localized disease only with no evidence of metastatic disease - patients may have received prior PDT, provided the patient has fully recovered and at least 28 days have elapsed since the PDT and there is clear evidence of disease progression at the local site or disease or at a new metastatic site.
- •oOther previous localised treatments targeting intrahepatic lesions such as selective internal radiation therapy (SIRT) , transarterial chemoembolisation (TACE) and radiofrequency ablation (RFA) are allowed, provided the patient has finished it at least 15 days prior to enrollment/randomization, with full recovery.
- •Asymptomatic subjects with known Central Nervous system (CNS) metastases are eligible, provided that all of the following criteria are met:
- •oMeasurable disease, per RECIST v1.1, must be present outside the CNS.
- •oThe patient has no history of intracranial hemorrhage or spinal cord hemorrhage.
- •oThe patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14
排除标准
- •Subjects with pleural effusion, pericardial effusion, or ascites with symptoms uncontrolled by medication or who require recurrent drainage procedures (once monthly or more frequently).
- •Leptomeningeal spread of disease.
- •Patient is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks prior to enrollment/randomization.
- •Other concomitant or prior malignancy within the last 5 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or in-situ carcinoma of the cervix.
- •History of inflammatory bowel disease or any autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, type I diabetes mellitus, vasculitis, or glomerulonephritis.
- •Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study.
- •Patients with controlled Type I diabetes mellitus on a stable insulin regimen are eligible.
- •Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are not eligible in case of occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors or high-potency or oral corticosteroids within the previous 12months.
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computerized tomography (CT) scan
- •oHistory of radiation pneumonitis/fibrosis in the radiation field is permitted.
- •Infections:
- •oSigns or symptoms of infection or therapeutic use of antibiotics (except prophylactic antibiotics) within 2 weeks prior to enrollment/randomization and severe infections within 4 weeks prior to enrollment/randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- •oKnown or current evidence of Human Immunodeficiency Virus (HIV) (test to be performed within 14 days of enrollment/randomization)
- •oActive or chronic hepatitis B or hepatitis C
- •?Patients with past/resolved hepatitis B virus (HBV) infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. HBV Deoxyribonucleic acid (DNA) must be obtained in patients with positive hepatitis B core antibody prior to enrollment/randomization.
- •?Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
- •oActive tuberculosis
- •Conditions leading to immune suppression or stimulation of the immune system, such as:
- •oPrior treatment with checkpoint inhibitors
- •oPatients who have received prior treatment with anti-CTLA-4 may be enrolled, provided at least 5 half-lives (approximately 75 days) have elapsed since the last dose of anti-CTLA-4 and there was no history of severe immune-mediated adverse effects from
研究者
相似试验
进行中（未招募）
2 期
Phase 2 Study Evaluating the Efficacy of the Combination of DKN-01 (DKK1 Inhibitor, Leap Therapeutics) and Pembrolizumab in the Treatment of Advanced or Recurrent Endometrial CancerEndometrial CancerNCT05761951M.D. Anderson Cancer Center8
招募中
2 期
AGADIR : Atezolizumab combined with EIK10001 (BDB001) and Immunogenic Radiotherapy in Patients with Advanced Solid Tumors2023-509492-16-00Institut Bergonie247
终止
2 期
A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal CancerGastric AdenocarcinomaGastroEsophageal CancerGastric CancerNCT04363801Leap Therapeutics, Inc.247
招募中
1 期
Integration of immunotherapy into first-line chemotherapy voor patients with epithelioid malignant pleural mesotheliomaMalignant pleural mesothelioma, epithelioid subtype (stage I-IV)MedDRA version: 20.0Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10059518Term: Pleural mesothelioma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-003229-31-BEAntwerp University Hospital15
已完成
2 期
Natural Killer(NK) Cell Combined With Programmed Death-1(PD-1) Antibody as Second Line Therapy for Advanced Driver Mutation Negative Non-small Cell Lung CancerNon-small Cell Lung CancerNCT03958097The First Hospital of Jilin University20