The purpose of this study is to learn more about a drug called Vorinostat (an experimental drug) in combination with chemoradiation. The intention of this study is to learn if this drug is safe for the participants and whether this drug with chemoradiation is able to further increase the clinical efficacy of chemoradiation, which is an approved therapy. The main question it aims to answer is: How may Vorinostat interact with standard chemotherapy and radiation therapy in head and neck cancer? Participants will receive the study drug (Vorinostat) as a pre-treatment, followed by standard chemoradiation.

开始日期2025-06-01

申办/合作机构

The Case Comprehensive Cancer Center

NCT04339751

/ Withdrawn临床2期IIT

The Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing's Disease

Background:
Cushing s disease is caused by excess ACTH hormone release by a benign tumor of the pituitary gland. It can lead to decreased quality of life and early death. The current best treatment for Cushing s disease is surgery. If surgery does not work or if the tumor returns, there are no more good treatment options. Vorinostat, which is approved to treat a type of lymphoma, might be a treatment option.
Objective:
To test vorinostat to see if it can kill tumor cells and change the number of hormones released in people with Cushing s disease.
Eligibility:
People ages 18 and older who have Cushing s disease and are scheduled for surgery under protocol 03-N-0164 to remove a tumor in their pituitary gland
Design:
Participants will be screened under protocol 03-N-0164.
Participants will stay in the hospital for 8 days before their surgery.
On the first day, participants will have a physical exam and blood tests. They will have their urine collected for testing all day. They will have an ECG: For this, small metal disks or sticky electrode pads will be placed on their chest to record heart activity.
For the next 7 days, participants will have blood tests and all-day urine collection. They will drink at least 2 liters of fluid per day. They will take the study drug by mouth each morning.
On the eighth day, participants will have their surgery. Leftover tissue will be collected for research.
On the day they are discharged from the hospital, participants will have a physical exam and blood tests.

开始日期2025-04-11

申办/合作机构

National Institute of Neurological Disorders & Stroke

NCT06693284

/ Recruiting早期临床1期IIT

A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST]

This is a single center Phase 0 "window of opportunity" trial for the treatment of newly diagnosed, PRC2 deficient, primary malignant peripheral nerve sheath tumors (MPNSTs) with a short course of the combination of mirdametinib and vorinostat prior to the most appropriate standard of care treatment for their specific tumor (typically localized radiation followed by surgical resection). Four to eight patients, 12 years of age or older and meeting the study's biomarker inclusion criteria, would be enrolled onto this trial. After voluntary written consent (assent with parent consent for minors) the patient undergoes MRI and PET imaging of the tumor and a needle biopsy to collect tumor is performed. Patients with histone H3K27 trimethylation deficient MPNST, as confirmed by immunohistochemistry, receive a single 28-day course of mirdametinib and vorinostat at standard oral dosing for each. At day 26, 27, or 28 the patient returns to clinic for a research visit repeating the baseline MRI and PET imaging and the needle biopsy for tumor tissue.
This ends direct study participation. The patient goes on to the most appropriate standard of care treatment for their MPNST. Information about the subsequent standard of care treatment is collected for the purposes of this study.

开始日期2024-12-01

申办/合作机构

University of Minnesota

100 项与伏立诺他相关的临床结果

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100 项与伏立诺他相关的转化医学

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100 项与伏立诺他相关的专利（医药）

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6,089

项与伏立诺他相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Insights into treatment of patients with mycosis fungoides or Sézary syndrome using mogamulizumab

Article

作者: Kim, Youn H. ; Akilov, Oleg ; Bagot, Martine ; Scarisbrick, Julia ; Ristuccia, Robert ; Wu, Wende ; Dwyer, Karen ; Foss, Francine

PURPOSE:

Mogamulizumab demonstrated improved outcomes vs. vorinostat across a range of disease and patient characteristics in patients with mycosis fungoides or Sézary syndrome in the MAVORIC trial.

MATERIALS AND METHODS:

This post-hoc analysis further examined MAVORIC data to assess factors associated with long-term response (ORR >12 months), time to next treatment (TTNT), and impact of concomitant steroid use, lymphopenia, and mogamulizumab-associated rash (MAR) on patient response.

RESULTS:

A higher proportion of patients achieved ORR lasting ≥4, 6, 8, or 12 months in the mogamulizumab vs. vorinostat arm. Long-term response was also observed in mogamulizumab-treated patients with more advanced disease (stage IVA1 [17/20], B2 blood involvement [18/20], and SS [14/20]). PFS was significantly longer (9.4 vs. 3.1 months; p < 0.0001) in mogamulizumab vs. vorinostat-treated patients taking concomitant steroids. Mogamulizumab-treated patients experienced longer TTNT vs. vorinostat. Lymphopenia and MAR were associated with response to mogamulizumab.

CONCLUSIONS:

MAVORIC demonstrated greater efficacy with mogamulizumab vs. vorinostat in relapsed/refractory patients with CTCL, including those with more advanced disease. Concomitant steroid use improved ORR and PFS but did not impact vorinostat outcomes. Overall responses occurred more frequently in mogamulizumab-treated patients that developed lymphopenia than those that did not. A higher percentage of patients with MAR had an overall response than those without MAR.

2025-12-31·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Discovery of novel biphenyl compounds bearing hydroxamic acid moiety as the first PD-L1/class I HDACs dual inhibitors

Article

作者: Huang, Yudan ; Ding, Xueyan ; Liu, Jieqing ; Ma, Junjie ; Yuan, Dandan ; Gao, Yali ; Liu, Han ; Li, Jin ; Xia, Lin ; Deng, Changchun ; Dai, Wenqi ; Wu, Xingye

Herein, we firstly reported a series of biphenyl compounds bearing hydroxamic acid moiety as PD-L1/class I HDACs dual inhibitors. Among them, compound 14 displayed the strongest inhibitory activity in vitro against HDAC2 and HDAC3 with IC₅₀ values of 27.98 nM and 14.47 nM, and had an IC₅₀ value of 88.10 nM for PD-1/PD-L1 interaction. Importantly, 14 could upregulate the expression of PD-L1 and CXCL10 in a PD-L1 low-expression cancer cell line (MCF-7), highlighting the potential to enhance efficacy by recruiting T-cell infiltration into TME and improving the response of PD-1/PD-L1 inhibitor associated with PD-L1 low-expression. Besides, we identified another compound, 22, which possessed the strongest inhibitory activity against PD-1/PD-L1 interaction with an IC₅₀ value of 12.47 nM, and effectively inhibited the proliferation of three cancer cell lines. Our results suggest that compounds 14 and 22 can be served as lead compounds of PD-L1/class I HDACs dual inhibitors for further optimisation.

2025-06-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Efficacy and safety of targeted therapy and immunotherapy in advanced vulvar squamous cell carcinoma: A scoping review

Review

作者: Arenhardt, Martina Parenza ; de Andrade, Diocesio Alves Pinto ; Dos Santos, Marcela Bonalumi ; de Melo, Andréia Cristina ; Gomes, Larissa Müller ; da Silva, Jessé Lopes ; Giannecchini, Giovanna Vieira

INTRODUCTION:

Vulvar squamous cell carcinoma (VSCC) is a rare gynecological tumor with limited treatment options for advanced stages. Current chemotherapy, adapted from cervical cancer protocols, often results in poor outcomes. This scoping review evaluates the efficacy and safety of immunotherapy and targeted therapies in advanced VSCC.

MATERIAL AND METHODS:

After extensive assessment, examination, and curation of relevant literature data, eight trials focused on immunotherapy or targeted therapy for advanced, recurrent, or metastatic VSCCs were identified and selected. The findings have been compiled and synthesized into a narrative overview, adhering to the PRISMA-ScR guidelines.

RESULTS:

The study analyzed four unpublished and four published trials, evaluating the efficacy and safety of immunotherapy or targeted therapy for VSCCs. Pembrolizumab was assessed in the KEYNOTE-028 and KEYNOTE-158 trials, showing objective response rates (ORRs) of 6 % and 10.9 %, respectively, and median overall survival (OS) between 3.8 and 6.2 months. CheckMate 358 reported a 20 % ORR for nivolumab. Combination strategies (ipilimumab plus nivolumab and pembrolizumab plus vorinostat) demonstrated efficacy with median OS of 7.6 and 17.5 months, respectively. Toripalimab showed an ORR of 33.3 %. Safety profiles were generally manageable, with common adverse events like fatigue and gastrointestinal disorders. Serious adverse events included grade 5 immune-related hepatitis and chronic kidney disease.

CONCLUSION:

Immunotherapy may be considered an option for VSCCs in the second-line setting. Despite the limited research on targeted therapies for VSCCs, combination approaches with immunotherapy demonstrate promising potential. Prioritizing the identification of biomarkers that predict responses to immune checkpoint inhibitors is essential.

项与伏立诺他相关的新闻（医药）

2025-04-29

·PRNewswire

Unravel Biosciences Announces Submission of RVL-001 Clinical Study Applications for Rett Syndrome and Pitt Hopkins Syndrome to Colombian Health Regulatory Authority

Submissions follow Ethics Committee Approvals for Both Studies Received Earlier This Month and Have Been Accepted for INVIMA Priority Review Under Fast Track Program for Rare Disease BOSTON, April 29, 2025 /PRNewswire/ -- Unravel Biosciences, Inc., ("Unravel"), an AI-enabled therapeutics company established to advance drugs for complex diseases, today announced the submission of clinical study applications for Unravel's RVL-001 proof of concept clinical trials for Rett syndrome ("RTT") and Pitt Hopkins syndrome ("PTHS") in Colombia. Both applications have been submitted under a pilot program by the Colombian Health Regulatory Agency ("INVIMA"), allowing for priority review and fast track approval for orphan and high unmet need diseases. Unravel anticipates study initiation in the early summer for both programs at the Universidad de Antioquia's Center for Technological Development ("PECET"), a clinical study center of excellence and designated INVIMA clinical trial site in Medellin, Colombia. Both RVL-001 proof of concept studies are designed as placebo-controlled, "n-of-1" trials with a target enrollment of 15 patients with RTT and 5 patients with PTHS. "Today's announcement represents an important milestone towards Unravel's evolution into a clinical-stage company," said Richard Novak, Ph.D., Unravel Co-Founder and CEO. "We look forward to INVIMA's expedited review of our study applications and are prepared to start patient dosing soon after we receive INVIMA approval." RTT and PTHS are both rare neurogenetic disorders starting in early childhood that lead to debilitating cognitive, motor and autonomic disability. Despite one approved treatment for RTT, there remains a significant unmet need for novel treatments having meaningful efficacy and acceptable safety and tolerability. There are no known treatments for PTHS. Unravel's proprietary BioNAV™ drug discovery platform identified RVL-001 as a potentially promising therapeutic drug for Rett Syndrome and PTHS. In addition to Unravel's RVL-001 program for RTT and PTHS, the company has also initiated development work on RVL-002, a first-in-class novel molecule for Rett syndrome. "The Rett and Pitt Hopkins Syndrome communities, including families, caregivers and treating physicians, have been eagerly awaiting the opportunity to participate in meaningful clinical research to find potentially beneficial therapeutics for their loved ones." said Dr. Carolina Lesmes, Pediatric Neurologist and Principal Investigator of the RVL-001 studies. "We are ready to initiate these two important studies to assess the safety and potential efficacy of RVL-001." About Unravel Biosciences Unravel Biosciences is a therapeutics company founded on the principle that biological networks inform clinical outcomes. By using primary patient data with AI systems biology computation, rapid in vivo screening, and clinical validation of discovered targets, Unravel enables drug development with unprecedented efficiency. Unravel leverages its proprietary BioNAV™ platform combining target and drug prediction with patient stratification by efficacy and toxicity response to find treatments for complex diseases. Unravel's platform has led to two clinical trials starting in 2025. Unravel's platform developed RVL002, a first-in-class new small molecule targeting mitochondrial metabolism, and RVL027 and RVL068, molecules targeting two novel mechanisms to treat dystonias. The rareSHIFT™ program provides platform access to foundation and biotech partners to accelerate and clinically derisk therapeutics. and SOURCE Unravel Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床研究快速通道优先审批

2025-04-29

·生物谷

复旦大学张朝、刘秀萍、王宇翔等合作揭示增强子RNA在肿瘤免疫治疗效果预测与药物联合方案筛选方面的作用价值

增强子是关键的远端表观元件，激活状态的增强子会转录出一段非编码RNA，即增强子RNA（eRNA），它们在基因表达调控中扮演着至关重要的角色。eRNA具有较高的组织和细胞特异性，且与肿瘤微环境中免疫细胞的浸润密切相关。同时，eRNAs与多种抗癌药物的敏感性存在联系。系统地研究eRNAs在癌症免疫治疗中的功能，对于在大规模癌症患者中筛选联合治疗药物具有重要意义。2025年4月15日，复旦大学基础医学院生化系/代谢分子医学教育部重点实验室的张朝团队与病理系的刘秀萍教授、王宇翔青年研究员合作在Cancer Research上发表了题为Characterization of an Enhancer RNA Signature Reveals Treatment Strategies for Improving Immunotherapy Efficacy in Cancer的研究，利用eRNA在肿瘤免疫微环境中的特性，建立了eRNA免疫治疗预测分数eRNA immunotherapy signature (eRIS)，eRIS可以用来表征免疫治疗的反应率和预测提高免疫治疗反应的联用药物，表现出良好的临床应用潜力。本研究通过综合分析来自超过10,000个TCGA样本的eRNA表达数据与肿瘤浸润免疫细胞的丰度，发现eRNA的表达与免疫细胞类型的分布关系，揭示了eRNA通过与肿瘤免疫细胞的相互作用，能够促进肿瘤免疫反应的强化，特别是在肿瘤免疫微环境中发挥重要调节作用。研究人员进一步发现，某些eRNA在免疫细胞中的表达变化可能是肿瘤免疫逃逸的关键因素，这为eRNA在免疫治疗中的应用提供了理论基础。在此基础上，研究团队开发了eRNA免疫治疗标志物（eRIS）系统，这一评分系统能够精准预测免疫治疗的反应效果，即高eRIS的患者在接受免疫治疗时表现出更好的反应率。研究结果表明，eRIS不仅能有效区分免疫治疗响应良好的患者与不良反应患者，还能为免疫治疗方案的个性化制定提供依据。进一步，通过对eRIS与免疫治疗药物的药物敏感性进行相关性分析，研究团队预测了潜在提高免疫治疗反应率的联用药物。并在低级别胶质瘤（LGG）IDH突变型和IDH野生型肿瘤中，分析了vorinostat与anti-PD-1这一组合的联合疗效，明确了联合治疗相比单药组和安慰剂组不仅能够显著提高免疫细胞的浸润，抑制肿瘤生长，还能显著提高小鼠的生存率。针对免疫细胞丰度变化的分析显示，联合治疗组的CD8+T细胞、CD3+细胞、CD45+细胞和IBA1+细胞的丰度均显著增加，证实了肿瘤微环境中T细胞和巨噬细胞丰度的增加，验证了eRIS作为免疫治疗反应标志物的有效性，特别是在肿瘤微环境中eRIS能够准确反映免疫细胞在肿瘤微环境中的变化。这一特性为eRIS在临床中的应用奠定了基础，为未来免疫治疗的个体化精准医疗提供了新的思路。图1. eRIS筛选到的免疫治疗联用药物在不同癌种和肿瘤亚型中的关联图谱复旦大学基础医学院张朝、王宇翔青年研究员，印第安纳大学韩冷教授，和复旦大学基础医学院刘秀萍教授为共同通讯作者。基础医学院博士研究生张晨阳和陈艳艳为该论文的共同第一作者。复旦大学基础医学院生化系的文波教授和刘赟教授，以及附属华山医院的齐曾鑫和袁一帆医生为本研究提供了大力支持。据介绍，张朝课题组致力于整合计算生物学与多组学方法，探索健康及复杂疾病组织中关键调控分子与远端调控元件的动态变化与功能机制，在Nature Communications (2019), Nucleic Acids Research (2021, 2022), Cancer Research (2022), Advanced Science (2023)，Cell Discovery (2024)，Science Advances (2025) 等期刊发表了多篇研究成果，团队这项研究是使用eRNA辅助肿瘤免疫治疗方面的首次尝试。该工作得到来自国家自然科学基金，上海市科委等项目的支持。论文链接：https://doi.org/10.1158/0008-5472.CAN-24-2289原文链接：https://shmc.fudan.edu.cn/news/2025/0424/c1892a145094/page.htm本文仅用于学术分享，转载请注明出处。若有侵权，请联系微信：bioonSir 删除或修改！

免疫疗法

2025-04-07

·诺华集团

诺华产品阿曲生坦获得美国FDA加速批准

阿曲生坦（Vanrafia®）作为一种基础疗法可以无缝加入IgA肾病现有的支持性治疗1，成为目前首款且唯一用于治疗原发性IgA肾病的选择性内皮素A受体拮抗剂III期临床研究显示，相较于安慰剂，阿曲生坦显著降低蛋白尿达36.1%（P<0.0001），在第6周即开始降低蛋白尿并持续至第36周，并具有良好的安全性和耐受性1,2IgA肾病持续进展，而现有管理存在不足，高达50%持续蛋白尿的IgA肾病患者在诊断后10-20年内进展至肾衰竭3-9这已经是诺华肾脏疾病产品线在不到一年时间里，获得的第三项美国FDA批准，也彰显了诺华在肾脏疾病治疗领域的领导地位诺华于4月3日宣布，诺华产品阿曲生坦获得美国食品药品监督管理局（FDA）的加速批准。这是一款强效选择性内皮素A（ETA）受体拮抗剂，用于降低存在快速进展风险的原发性免疫球蛋白A肾病（IgA肾病）成人患者的蛋白尿。通常定义是尿蛋白肌酐比值（UPCR）≥1.5g/g1。IgA肾病是一种进行性的原发性肾小球疾病，通常由免疫系统攻击肾脏引致，常表现为肾小球炎症和蛋白尿10。它是最常见的自身免疫性肾小球疾病之一，且每位患者的病程都具有独特性11,12。高达50%持续蛋白尿的IgA肾病患者在诊断后10-20年内进展至肾衰竭，需要维持性透析和/或肾移植3-10，IgA肾病患者对不同治疗方案的反应也因人而异12,13。有效且不同作用机制的治疗手段可以帮助医生选择更适合患者的治疗方案12。阿曲生坦是一种每日服用一次的非激素类口服药物，可加入现有的支持性治疗中，包括肾素-血管紧张素系统（RAS）抑制剂，且可选择是否同时使用钠-葡萄糖协同转运蛋白-2（SGLT2）抑制剂1,2。美国医师学会院士、斯坦福大学医学中心肾病学教授兼肾小球疾病中心主任、阿曲生坦ALIGN研究研究者及指导委员会成员Richard Lafayette 博士此次获批标志着IgA肾病治疗领域的重要里程碑，为患者提供了一种新的治疗选择，可以无缝加入现有的治疗方案。阿曲生坦是一种选择性的ETA受体拮抗剂，可有效降低蛋白尿这一IgA肾病中的主要危险因素。对于那些往往可能进展至肾衰竭的患者来说，及早采取果断行动对于改善治疗结果至关重要。获批支持数据阿曲生坦的加速获批基于ALIGN三期临床研究的预设中期分析，该研究比较了36周时阿曲生坦相较于安慰剂的蛋白尿降低情况1。与安慰剂相比，接受阿曲生坦联合RAS抑制剂治疗的患者实现了具有临床意义的显著蛋白尿降低，达36.1%（P<0.0001），疗效在第6周时即开始显现，并持续至第36周1,2,14。阿曲生坦对尿蛋白肌酐比值（UPCR）的影响在各亚组中表现出一致性，包括年龄、性别、种族以及基线疾病特征（如eGFR和蛋白尿水平）1。此外，在接受RAS抑制剂和SGLT2抑制剂联合治疗的预设亚组中，阿曲生坦显示了一致的疗效，阿曲生坦组较安慰剂组的UPCR降低了37.4%。ALIGN研究表明，阿曲生坦具有良好的安全性和耐受性，与之前报道的数据一致1。使用阿曲生坦治疗的患者中≥2%报告了不良事件，相较安慰剂组更常见的不良事件包括外周水肿、贫血和肝转氨酶升高1。由于某些内皮素受体拮抗剂可能导致氨基转移酶升高、肝毒性甚至肝功能衰竭，临床医生应在开始使用阿曲生坦治疗前以及在治疗过程中，根据临床需要进行肝酶检测。此外，阿曲生坦可能导致严重的出生缺陷1。阿曲生坦的使用不需要实施风险评估与缓解策略（REMS）管理*。*风险评估与缓解策略（REMS）是美国食品药品监督管理局（FDA）要求某些具有严重安全隐患的药物实施的一种药物安全计划，确保药物的益处大于其风险15。— 声明 — 1.本资料的目的在于传递医药前沿信息和研究进展，非广告用途。本资料中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。2.本资料中涉及的产品尚未在中国大陆获批。— 参考文献 — （滑动查看更多）1. VANRAFIA prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corp; April 2025.2. Heerspink HJL, Jardine M, Kohan DE, et al. Atrasentan in Patients with IgA Nephropathy. N Engl J Med. 2025;392(6):544-554. doi:10.1056/NEJMoa24094153. Xie J, Kiryluk K, Wang W, et al. Predicting progression of IgA nephropathy: new clinical progression risk score. PLoS One. 2012;7(6):e38904. doi:10.1371/journal.pone.00389044. Rodrigues JC, Haas M, Reich HN. IgA Nephropathy. Clin J Am Soc Nephrol. 2017;12(4):677-686. doi:10.2215/CJN.074207165. Pitcher D, Braddon F, Hendry B, et al. Long-Term Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2023;18(6):727-738. doi:10.2215/CJN.00000000000001356. Hastings MC, Bursac Z, Julian BA, et al. Life Expectancy for Patients From the Southeastern United States With IgA Nephropathy. Kidney Int Rep. 2017;3(1):99-104. Published 2017 Aug 24. doi:10.1016/j.ekir.2017.08.0087. Sim JJ et al. Poster TH-PO615 presented at: ASN Kidney Week 2023; November 2-5, 2023; Philadelphia, PA.8. Bobart SA, Alexander MP, Shawwa K, et al. The association of microhematuria with mesangial hypercellularity, endocapillary hypercellularity, crescent score and renal outcomes in immunoglobulin A nephropathy. Nephrol Dial Transplant. 2021;36(5):840-847. doi:10.1093/ndt/gfz2679. Saha MK et al. Poster TH-PO1016 presented at: ASN Kidney Week 2019; November 5-10, 2019; Washington, DC.10. National Institute of Diabetes and Digestive and Kidney Diseases. IgA nephropathy. Available from: https://www.niddk.nih.gov/health-information/kidney-disease/iga-nephropathy. Accessed March 2025.11. Kwon CS, Daniele P, Forsythe A, Ngai C. A systematic literature review of the epidemiology, health-related quality of life impact, and economic burden of immunoglobulin A nephropathy. J Health Econ Outcomes Res. 2021;8(2):36-45. doi:10.36469/001c.2612912. Kidney Disease: Improving Global Outcomes (KDIGO) 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100(4):S1-S276. doi:10.1016/j.kint.2021.05.02113. Boyd JK, Cheung CK, Molyneux K, Feehally J, Barratt J. An Update on the Pathogenesis and Treatment of IgA Nephropathy. Kidney Int. 2012;81(9):833-843.14. ClinicalTrials.gov. NCT04573478. A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function. Available from https://clinicaltrials.gov/study/NCT04573478. Accessed March 2025.15. U.S. Food&Drug Administration. Risk Evaluation and Mitigation Strategies | REMS. Available from https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems. Accessed April 2025.

加速审批临床结果临床3期临床2期

100 项与伏立诺他相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06320	伏立诺他	L01XX38	DB02546

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
皮肤T细胞淋巴瘤	美国	Merck Sharp & Dohme Corp.	2006-10-06

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
难治性多发性骨髓瘤	临床3期	-	Merck Sharp & Dohme Corp.	2008-12-01
非鳞状非小细胞肺癌	临床3期	-	Merck Sharp & Dohme Corp.	2007-05-01
恶性胸膜间皮瘤	临床3期	-	Merck Sharp & Dohme Corp.	2005-06-30
ER阳性乳腺癌	临床2期	美国	Merck Sharp & Dohme Corp.	2021-03-11
转移性乳腺癌	临床2期	美国	Merck Sharp & Dohme Corp.	2021-03-11
肛门肿瘤	临床2期	法国	Merck Sharp & Dohme Corp.	2020-10-28
阴茎肿瘤	临床2期	法国	Merck Sharp & Dohme Corp.	2020-10-28
转移性头颈部鳞状细胞癌	临床2期	法国	Merck Sharp & Dohme Corp.	2020-10-28
鳞状细胞癌，转移	临床2期	法国	Merck Sharp & Dohme Corp.	2020-10-28
鳞状细胞肺癌	临床2期	法国	Merck Sharp & Dohme Corp.	2020-10-28

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02638090 (CTgov)	临床1/2期	转移性非小细胞肺癌	120	Vorinostat+pembrolizumab (Phase I Dose Escalation)	觸獵衊獵簾範願築鹹餘 = 淵醖襯鹹築壓獵觸蓋鹽壓糧獵鬱鏇獵餘觸顧憲 (鑰艱糧夢淵夢遞獵簾選, 繭顧艱鹹願鹽願襯齋願 ~ 醖願鹹遞築鹹繭齋繭顧)	-	2025-05-04
				pembrolizumab (Arm A: Pembrolizumab)	築廠膚廠糧觸蓋糧廠積(淵鹽糧簾艱壓鑰積襯鑰) = 願膚憲選遞憲衊網顧醖鹽鹹夢製壓遞鬱壓製鏇 (遞構範觸蓋廠積艱顧夢, 醖蓋構膚選鹽願壓襯願 ~ 積糧醖鏇選築積齋艱築) 更多
AACR2025	N/A	肺腺癌	-	Vorinostat	鬱齋蓋淵鑰獵鑰繭獵艱(艱鹹壓憲顧範窪鏇艱範) = 選觸顧鹽選醖醖憲艱艱網遞蓋簾鏇淵齋顧鹽積 (廠觸膚鬱襯獵膚糧衊鑰 )	积极	2025-04-27
NCT00503971 (CTgov)	临床1/2期	非小细胞肺癌	33	Erlotinib+Vorinostat (Vorinostat Plus Erlotinib Phase II)	齋窪繭獵蓋壓製夢簾選 = 襯網鑰鹽餘餘鏇構築選膚網壓繭衊構糧醖齋憲 (糧齋網願遞獵觸糧鏇衊, 齋淵築築艱鑰願鏇鬱顧 ~ 鏇糧網製餘製夢淵鹹選) 更多	-	2025-03-07
				Erlotinib+Vorinostat (Vorinostat Plus Erlotinib Phase I)	夢網窪廠襯衊衊鬱製艱 = 壓網構艱遞蓋積獵鑰積襯獵醖醖衊獵糧願憲獵 (築鹹範襯鬱築憲獵網積, 鹽憲鑰衊衊鹽蓋網顧膚 ~ 積顧網醖築膚鹽醖獵顧)
NCT02619253 (Phase I/IB, CTgov)	临床1期	晚期尿路上皮癌 \| 肾细胞癌 \| 膀胱癌	52	vorinostat+pembrolizumab (Expansion Cohort A)	襯艱鏇簾製願窪鏇憲膚 = 鹽願顧網憲齋遞積範遞襯獵壓糧壓餘觸艱範願 (範積構餘衊夢築憲齋選, 糧積願選鹽衊鹽鏇淵鹹 ~ 蓋廠鏇網鏇鬱夢齋夢壓) 更多	-	2024-11-18
				vorinostat+pembrolizumab (Expansion Cohort B)	襯艱鏇簾製願窪鏇憲膚 = 網鏇遞製築蓋顧鑰遞築襯獵壓糧壓餘觸艱範願 (範積構餘衊夢築憲齋選, 鹽選遞鬱糧膚製憲壓築 ~ 獵糧鑰襯壓廠襯艱顧齋) 更多
NCT04357873 (PEVOsq, AACR2024) 人工标引	临床2期	鳞状细胞癌 PD-L1 expression \| tumor-infiltrating lymphocytes quantification \| HPV typing ... 更多	112	Pembrolizumab anVorinostatVorinostat combination	-	积极	2024-03-22
				Pembrolizumab + Vorinostat (HPV+)	憲蓋壓積積鏇醖積糧齋(願壓糧願鑰鹹淵淵艱鏇) = 積蓋鏇鹽繭艱願齋遞鬱淵襯鏇積積範窪襯觸鑰 (衊廠構膚鏇膚餘衊鹽艱 )
NCT03198559 (CTgov)	临床1/2期	HIV感染	5	Vorinostat, NDC 00006-0568-40+Disulfiram, (National Drug Code) NDC 0378-4141-01	鬱選憲壓範衊鏇願廠鏇 = 窪選選鑰蓋鹹壓範鏇鹹觸齋繭簾窪網製築夢鑰 (齋壓積糧鑰獵製願糧願, 廠獵齋鹽蓋獵憲壓艱齋 ~ 齋顧淵網鏇鏇鬱鏇繭鑰) 更多	-	2024-02-09
NCT02316340 (CTgov)	临床2期	转移性结直肠癌	42	Vorinostat+Hydroxychloroquine (Study Arm - VOR With HCQ)	蓋壓淵齋蓋觸鑰糧鹽襯(鑰鹹遞艱壓糧範襯獵餘) = 齋襯艱築醖構窪網觸鏇範築醖遞鏇廠蓋選遞艱 (範襯鹽夢襯獵遞憲憲醖, 鏇積顧膚壓鬱鑰鬱餘齋 ~ 醖繭網選鑰網鏇鏇積築) 更多	-	2024-01-05
				Regorafenib (Control Arm - Regorafenib)	蓋壓淵齋蓋觸鑰糧鹽襯(鑰鹹遞艱壓糧範襯獵餘) = 範齋顧襯構網獵構顧襯範築醖遞鏇廠蓋選遞艱 (範襯鹽夢襯獵遞憲憲醖, 蓋鹹遞窪構艱選艱網築 ~ 製膚醖遞醖選繭網繭廠) 更多
NCT01802333 (S1203, Pubmed \| Leukemia) 人工标引	临床3期	急性髓性白血病 NPM1 \| FLT3	738	Daunorubicin and cytarabine (DA)	窪觸鏇蓋範願觸積鹽齋(顧艱醖窪鏇鹹蓋蓋窪窪) = 選膚膚顧齋鹽窪構夢鹽鑰積積壓鬱簾範範憲蓋 (醖觸構壓築願選顧鏇膚 ) 更多	不佳	2024-01-01
				Idarubicin with higher dose cytarabine (IA)	窪觸鏇蓋範願觸積鹽齋(顧艱醖窪鏇鹹蓋蓋窪窪) = 壓簾醖範顧夢顧淵獵鏇鑰積積壓鬱簾範範憲蓋 (醖觸構壓築願選顧鏇膚 ) 更多
EUCTR2019-003839-33-FR \| NCT04357873 (PEVOsq, ESMO 12023 \| ESMO 22023) 人工标引	临床2期	宫颈鳞状细胞癌	25	Pembrolizumab + Vorinostat	鹽積鹽鬱鏇窪選壓齋醖(鹽膚膚鏇齋憲顧鏇選壓) = 醖鏇繭選壓繭淵齋廠觸壓築醖齋觸觸襯淵襯憲 (鬱廠衊遞構淵憲顧夢艱, 19.7 ~ 61.5) 更多	积极	2023-10-22
EUCTR2019-003839-33-FR \| NCT04357873 (PEVOsq, ESMO 12023 \| ESMO 22023) 人工标引	临床2期	肛门鳞状细胞癌 p16	29	Pembrolizumab + Vorinostat	簾鬱鹹膚壓醖衊夢鑰餘(簾憲窪鏇鹽積憲膚膚築) = 蓋製齋鬱淵鏇窪艱製鏇網範醖憲構顧襯夢積網 (壓衊簾壓簾觸齋襯襯鑰, 17.2 ~ 47.9) 更多	积极	2023-10-22