CTIS2022-500676-59-00招募中1 期
ivolumab in combination with cisplatin and 5-fluorouracil as induction therapy in children and adults with EBV-positive nasopharyngeal carcinoma - NPC-Nivo
Gpoh Gemeinnützige GmbH0 个研究点目标入组 57 人开始时间: 2022年4月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 57
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
- 年龄范围
- 0 至 64（—）
- 性别
- All
入选标准
- •Histologically confirmed new diagnosis of nasopharyngeal carcinoma according to the current WHO classification in children and adolescents aged between 3 and 17 years, Alternatively to (1): histologically confirmed new diagnosis of EBV-positive nasopharyngeal carcinoma, WHO stage II or III, in subjects = 18 years, Stage II or higher in patients = 25 years of age, stage III and IV in patients > 25 years of age (AJCC, 8th edition), Measurable disease by MRI per RECIST 1.1 criteria, Written informed consent by legal guardians (if patient not = 18 years) and patient prior to study participation, Sufficient tumor tissue to be sent for central review, including PD-L1 staining, either as 2 full blocks or a minimum of 25 slides, obtained from core biopsy, punch biopsy, excisional biopsy or surgical specimen
排除标准
- •Newly diagnosed nasopharyngeal carcinoma, Stage I in all patients, Stage II in patients > 25 years of age, The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication, The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study, Recurrent nasopharyngeal carcinoma, Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol, Lactating females, The subject is unwilling or unable to follow the procedures outlined in the protocol, The subject is mentally or legally incapacitated, Nasopharyngeal carcinoma diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy, Prior chemotherapy and/or radiotherapy, Other active malignancy, Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection, Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, The subject received an investigational drug within 30 days prior to inclusion into this study, Subjects with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol, Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before start of therapy. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease, Subjects who are enrolled in another clinical trial, Subjects with prior organ allograft or allogenic bone marrow transplantation, 24.Subjects, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities, Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), Inadequate hematologic, renal or hepatic function, Hearing loss > 20 dB loss at 3 kHz, History of allergy or hypersensitivity to platinum-containing compounds or other study drug components, Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening), Vaccinated with live attenuated vaccines within 4 weeks of the first dose of the study drug, Adequate performance status (Karnofsky score = 60 for patients (age = 16), Lansky score = 60 (age < 16)
研究者
相似试验
招募中
2 期
ivolumab in combination with cisplatin and 5-fluorouracil as induction therapy in children and adults with EBV-positive nasopharyngeal carcinomaC11Malignant neoplasm of nasopharynxDRKS00027098Gesellschaft für pädiatrische Onkologie und Hämatologie (GPOH)57
招募中
2 期
Nivolumab in Children and Adults With Nasopharyngeal CarcinomaNasopharyngeal CancerNasopharyngeal NeoplasmsNasopharynx CancerNasopharyngeal CarcinomaNCT06019130German Society for Pediatric Oncology and Hematology GPOH gGmbH57
已完成
2 期
An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin plus 5-fluorouracil versus Carboplatin plus Weekly Paclitaxel in Patients with Inoperable Locally Recurrent or Metastatic DiseaseSquamous Cell Carcinoma of the AnusCancer - Bowel - AnalACTRN12616000061437Australasian Gastro-Intestinal Trials Group (AGITG)91
进行中（未招募）
不适用
cetuximab, fluorouracil ( 5-FU) and cisplatin alone or with docetaxel in recurrent and/or metastatic head and neck cancerPatients with first-line recurrent and/or metastatic SCCHN (stage III/IV) unsuitable for local therapies are eligible for this chemotherapy study.MedDRA version: 14.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-006923-30-DECharité Campus Benjamin Franklin180
进行中（未招募）
1 期
Study of Nivolumab and Ipilimumab plus chemotherapy as a treatment for patients with stageIV lung cancer with brain metastases.on-small cell lung cancer with brain metastasisMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-000425-27-ESFundación GECP71