LIGHTBEAM-U01 Substudy 01B: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors

This study is a rolling arm study of pembrolizumab in combination with investigational agents in pediatric participants with relapsed or refractory classical Hodgkin lymphoma (cHL), solid tumors with microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) or tumor mutational burden-high (TMB-H), or advanced melanoma. This study will have 2 parts: a safety lead-in to demonstrate a tolerable safety profile and confirm a preliminary recommended phase 2 dose (RP2D) (Part 1) followed by an efficacy evaluation (Part 2). Participants will be assigned to a treatment arm (either Part 1 or Part 2) that is open for enrollment.
There will be no hypothesis testing in this study.

开始日期2024-07-05

申办/合作机构

Merck Sharp & Dohme LLC

EUCTR2021-004564-94-PL / Not yet recruiting临床3期

A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants with Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007) - A Phase 3 study of MK-7684A in combination with chemotherapy in metastatic NSCLC

开始日期2022-02-21

申办/合作机构

Merck Sharp & Dohme LLC

NCT04305054 / Recruiting临床1/2期

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02B

Substudy 02B is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.
The goal of substudy 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy.
Arm 1: Pembrolizumab + Vibostolimab was added in the base protocol on 13-Nov-2019, and enrollment into this arm has been completed. Arm 2: Pembrolizumab was added in the base protocol on 13-Nov-2019, and enrollment stopped prematurely on 15-Aug-2022. Arm 3: Coformulation Pembrolizumab/Quavonlimab was added in Amendment 01 on 20-Oct-2020, and enrollment stopped prematurely on 15-Aug-2022. Arm 4: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib was added in Amendment 01 on 20-Oct-2020, and enrollment is ongoing. Arm 5: Coformulation Favezelimab/Pembrolizumab, Arm 6: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA), and Arm 7: Coformulation Favezelimab/Pembrolizumab + Vibostolimab were added in Amendment 04 on 10-May-2023, and enrollment for these arms will be initiated in July 2023.

开始日期2020-07-01

申办/合作机构

Merck Sharp & Dohme Corp.

100 项与 Vibostolimab 相关的临床结果

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100 项与 Vibostolimab 相关的转化医学

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100 项与 Vibostolimab 相关的专利（医药）

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项与 Vibostolimab 相关的文献（医药）

2023-08-01·Cancer letters

TIGIT immune checkpoint blockade enhances immunity of human peripheral blood NK cells against castration-resistant prostate cancer

Article

作者: Xing, Nianzeng ; Wang, Jing ; Li, Jianxing ; Ma, Jianlin ; Wang, Fangming ; Liu, Fei ; Yang, Feiya ; Xu, Tianli ; Liang, Jing ; Liu, Shuai ; Liu, Donghua

Castration-resistant prostate cancer (CRPC) patients have a 14-month median survival, emphasizing the need for alternative treatments. Previously, we demonstrated that expanded high-dose natural killer (NK) cells derived from human peripheral blood exhibit therapeutic efficacy against CRPC. However, which immune checkpoint blockade promotes NK cell antitumor immunity against CRPC remains unknown. Here, we explored immune checkpoint molecule expression in NK and CRPC cells during their interactions, and identified that the T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif domain (TIGIT) monoclonal antibody (mAb), vibostolimab, significantly enhanced NK cell cytotoxicity against CRPC cells and cytokine production in vitro, demonstrated by upregulation of degranulation marker CD107a and Fas-ligand (Fas-L) and increased interferon-gamma (IFN-γ) and tumor necrosis factor-alpha secretion. TIGIT blockade increased Fas-L expression and IFN-γ production via the NF-κB signaling pathway and restored degranulation via the mitogen-activated protein kinase ERK (extracellular signal-regulated kinase) kinase/ERK pathway in activated NK cells. Vibostolimab significantly enhanced NK cell antitumor effects against CRPC in two xenograft mouse models. Vibostolimab also increased T cell chemotaxis induced by activated NK cells in vitro and in vivo. Overall, blocking TIGIT/CD155 signaling enhances the antitumor effect of expanded NK cells against CRPC; this finding supports the translational application of TIGIT mAb and NK cell combination strategies from bench to bedside for CRPC treatment.

2023-04-01·ESMO open

Anti-TIGIT therapies for solid tumors: a systematic review

Review

作者: Barlesi, F ; Rousseau, A ; Parisi, C

Programmed death-ligand 1[PD-(L)1], cytotoxic T-lymphocyte associated protein 4 (CTLA-4), and lymphocyte-activation gene 3 (LAG-3) inhibitors are recent breakthroughs in cancer treatment, however not all patients benefit from it. Thus new therapies are under investigation, such as anti-TIGIT [anti-T-cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibitory motif domains] antibodies. TIGIT is an immune checkpoint inhibiting lymphocyte T cells by several mechanisms. In vitro models showed its inhibition could restore antitumor response. Furthermore, its association with anti-PD-(L)1 therapies could synergistically improve survival. We carried out a review of the clinical trial about TIGIT referenced in the PubMed database, finding three published clinical trials on anti-TIGIT therapies. Vibostolimab was evaluated in a phase I alone or in combination with pembrolizumab. The combination had an objective response rate of 26% in patients with a non-small-cell lung cancer (NSCLC) naïve of anti-programmed cell death protein 1 (anti-PD-1). Etigilimab was tested in a phase I alone or in combination with nivolumab, but the study was stopped due to business reasons. In the phase II CITYSCAPE trial, tiragolumab demonstrated higher objective response rate and progression-free survival in combination with atezolizumab than atezolizumab alone in advanced PD-L1-high NSCLC. The ClinicalTrials.gov database references 70 trials of anti-TIGIT in patients with cancer, 47 of them with ongoing recruitment. Only seven were phase III, including five about patients with NSCLC, mostly with combination therapy. Data from phase I-II trials highlighted that targeting TIGIT represents a safe therapeutic approach, with an acceptable toxicity profile maintained when adding anti-PD-(L)1 antibodies. Frequent adverse events were pruritus, rash, and fatigue. Grade 3-4 adverse events were reported in nearly one in three patients. Anti-TIGIT antibodies are under development as a novel immunotherapy approach. A promising research area includes the combination with anti-PD-1 therapies in advanced NSCLCs.

2022-02-01·Annals of oncology : official journal of the European Society for Medical Oncology

Anti-TIGIT to overcome resistance to immune checkpoint inhibitors in lung cancer: limits and potentials

Communications

作者: de Marinis, F ; Passaro, A ; Attili, I

In the immune checkpoint era, the clin. course of advanced or metastatic non-small-cell lung cancer (NSCLC) has remarkably improved.Treatment with immune check-point inhibitors (ICIs), namely anti-programmed cell death protein 1 (PD-1) and anti-programmed death-ligand 1 (PD- L1), has led to impressive long-term survival outcomes in epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK) wild-type (wt) NSCLC, either as monotherapy (in the first-line setting for PD-L1 50% tumors) or in combination with platinum-based chemotherapy, in both squamous and non-squamous histol.Herein authors present the first-in-human phase I trial of vibostolimab, an anti-TIGIT humanized IgG1 (IgG1) monoclonal antibody, alone or in combination with pembrolizumab.Among the 76 patients in the dose-finding part A (15 with NSCLC), overall response rate (ORR) was 0% with vibostolimab monotherapy and 7% with the combination and in part B, 106 NSCLC patients were treated.As TIGIT coexists with other immune signals with regulatory functions and competitive binding on the same immune pathway, co-targeting more components of the pathway would be synergistic, as it was demonstrated in the preclin. setting.In addition, as TIGIT is expressed on different immune cells, the most appealing approach to tailor anti-TIGIT treatment would be to better define the TME compositionIndeed, the adoption of Fc-competent IgG1 anti-TIGIT compounds (e.g. tiragolumab, vibostolimab) potently activates antigen-presenting cells and enhances T-cell activation through pro-inflammatory cytokines and chemokines.Results clearly highlight that single-agent anti-TIGIT is not effective, whereas the coadministration with an anti-PD-1 or anti-PD-L1 is needed to exert immune antitumor activity.

项与 Vibostolimab 相关的新闻（医药）

2024-06-11

·医药地理

国内儿童肿瘤药物研发新突破：Ⅲ期临床阶段创新药物进展

01 儿童肿瘤现状与药物研发困境儿童肿瘤是一个全球性的健康挑战，它不仅是儿童和青少年的主要死亡原因，也是他们身上的沉重疾病负担。在我国，儿童肿瘤的情况同样不容乐观。统计数据显示，2018至2020年间，我国平均每年新增的儿童和青少年肿瘤患者达到了4.038万名，发病率达126.48/百万。对比此前国内研究中国儿童肿瘤发病率显示小于100/百万的发病率，国内儿童肿瘤发病率被严重低估。然而，面对如此严峻的儿童肿瘤形势，儿童肿瘤药物的开发却远远滞后于成人肿瘤药物的发展。源于经济、伦理和法律问题等多重障碍，制药公司对于在儿童身上研究药物和生物制品一直持谨慎态度，许多儿童患有的肿瘤都是罕见疾病，这使得企业为他们开发创新疗法的经济激励相对较小。因此，新的肿瘤药物在儿童肿瘤适应症上获批数量较少，且往往滞后于成人肿瘤适应症。这迫切要求我们寻找更多更新、毒性更低的儿童肿瘤治疗方法。 02 国内儿童抗肿瘤药物研发进展值得欣慰的是，我国在儿童抗肿瘤创新药研发方面已取得一定进展。据中国儿童用药数据库查询结果显示，截至2024年5月，共有6个处于Ⅲ期临床阶段的儿童抗肿瘤创新药研发项目，其中4个项目的试验药已在国外获批上市，另外2个项目的试验药则是全球范围内尚未上市的创新药物。这些待上市药物适应症广泛，包括黑色素瘤、软组织肉瘤、骨肉瘤、结直肠癌、白血病等。表：国内处于Ⅲ期临床阶段的儿童抗肿瘤创新药物来源：中国儿童用药数据库，中国医药工业信息中心曲贝替定 (Trabectedin; ET-743) 是一种从加勒比海被囊动物红树海蛸体内分离提取出来的烷化剂，是第一个海洋来源的新型抗软组织肿瘤药物。由Phamma Mar SA(法马马有限公司)公司最早研发，2007 年曲贝替定获得欧盟批准用于治疗软组织肉瘤。2015 年，曲贝替定获得 FDA 批准上市，用于接受过蒽环类药物治疗的患有不可切除或转移脂肪肉瘤或平滑肌肉瘤患者的治疗。恩考芬尼（ENCORAFENIB）于2018年6月27日首次获得FDA的批准上市，在国内处于Ⅰ期临床阶段，是一种小分子靶向药物，对伴有BRAF V600E、V600K突变的黑色素瘤有较好的疗效。2020年，辉瑞恩考芬尼BRAFTOVI联合礼来公司的单克隆抗体西妥昔单抗获得FDA批准，用于治疗BRAFV600E突变的晚期结直肠癌患者。奈拉滨（Nelarabine）是一种核苷类似物，在体内代谢后可嵌合入DNA，从而抑制DNA合成，对T细胞具有选择性细胞毒作用。2005年10月28日，FDA通过快通道批准英国葛兰素公司研发奈拉滨静脉注射液用于治疗至少对两种以上化疗方案无应答或复发的T细胞型淋巴母细胞白血病(T-ALL)及T细胞型淋巴母细胞淋巴瘤(T-LBL)这两种相对少见、恶性度高的血液系统肿瘤。纳武利尤单抗（nivolumab）+瑞拉利单抗（relatlimab）：纳武利尤单抗是一种PD-1抑制剂；瑞拉利单抗是一种新型的免疫检查点抑制剂，可阻断在T细胞表面发现的LAG-3。2022年3月19日，FDA批准了百时美施贵宝的新药瑞拉利单抗联合纳武利尤单抗的固定剂量组合Opdualag上市。相关研究表明，新辅助化疗纳武利尤单抗+瑞拉利单抗对于可切除的临床III期或IV期低转移性黑色素瘤患者联合免疫治疗的病理完全缓解率为57%。维博利单抗（Vibostolimab，MK-7684A）是一款由默沙东研发的新型免疫治疗药物，属于人源化单克隆抗体，靶向的是T细胞上的免疫检查点受体TIGIT，通过与具有免疫球蛋白和ITIM结构域的T细胞免疫受体结合，阻断TIGIT与其配体CD112和CD155之间的相互作用，从而激活T淋巴细胞，帮助破坏肿瘤细胞。 03 儿童肿瘤治疗的突破与希望面对儿童肿瘤这一全球性的健康挑战，我们虽然面临着巨大的压力和困难，但我国在新药研发领域所取得的进展无疑为我们带来了希望的曙光。这些Ⅲ期临床阶段的儿童抗肿瘤创新药研发项目，不仅代表着我国医药科技的飞速发展，更承载着无数患儿和家庭的期盼与希望，为我国儿童肿瘤患者带来更加有效、安全的治疗选择。然而，新药研发之路仍任重道远。我们需要继续加大投入，加强国际合作，共同攻克儿童肿瘤这一医学难题。同时，我们也呼吁社会各界关注儿童肿瘤患者的需求，为他们提供更多的关爱和支持。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

临床3期上市批准申请上市临床2期

2024-05-23

·BioPharmaDive

ASCO24: An early look at cancer drug study results

BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line!Today, were interrupting our usual rundown of industry news to highlight notable clinical trial updates ahead of next weeks American Society of Clinical Oncologys annual meeting. On Thursday, conference organizers released abstracts, or snapshots, of most of the studies set to be presented at the meeting, which will be held in Chicago from May 31 to June 4.Note: So-called late-breaking abstracts, which often feature particularly consequential trial findings, arent available until the day the relevant studies are presented. This year, that group includes anticipated data on Novartis therapy Scemblix in leukemia, GSKs Blenrep in multiple myeloma and AstraZeneca and Daiichi Sankyos Enhertu treatment in breast cancer.Abstract #9507: Analysts have closely tracked a dual-targeting antibody drug that Immunocore is developing for a type of skin cancer called cutaneous melanoma. Trial results included in an ASCO abstract showed that, among 31 evaluable people who previously received immunotherapy, Immunocores drug led to partial tumor responses in four, or 13%. Including study participants whose disease was considered stable, the so-called clinical benefit rate was 61%. Though slightly below analysts expectations, the data are roughly similar to the results for Bristol Myers Squibbs Odualag in a comparable patient population. Immuncore recently began a Phase 3 trial of its drug, called brenetafusp. Ned PagliaruloAbstracts #5502, 9506: Drugmakers have hoped that targeting an immune cell protein called TIGIT could build on the success seen with checkpoint inhibitors like Merck & Co.s Keytruda and Bristol Myers Squibbs Opdivo. But trial results to date have been mixed and new data included in ASCO abstracts Thursday probably wont settle any debates. On one hand, Phase 2 trial findings for Mercks TIGIT-targeting drug vibostolimab coformulated with Keytruda shrank or eliminated tumors in a larger share of women with a type of endometrial cancer than Keytruda alone. On the other, data from a Phase 1/2 trial of Keytruda, vibostolimab and a third experimental immunotherapy called quavonlimab in advanced melanoma patients werent good enough for the Merck to continue enrolling patients. Jonathan GardnerAbstract #3508: An experimental cocktail of six drugs substantially extended survival and delayed tumor growth, compared to a standard therapy, in people with previously treated metastatic colon cancer, according to an ASCO abstract. The regimen includes two drugs developed by Arcus Biosciences: etrumadenant, a so-called adenosine receptor antagonist, and zimberelimab, a checkpoint inhibitor. Median overall survival among the 75 patients randomized to the cocktail was 19.7 months, versus 9.5 months for the 37 given Stivarga in the Phase 1b/2 study. Arcus is closely partnered with Gilead Sciences, although their focus has been on developing zimberelimab and another immunotherapy. Ned PagliaruloAbstract #5010: Johnson & Johnson is one of many companies now exploring radiopharmaceuticals, which deliver radiation directly to a tumor. Its first chance to break into the field could be JNJ-6420, a drug that executives already billed as a potential future blockbuster. J&J aims to show the drug can slow tumor progression in men whose prostate cancer has progressed after hormone therapies. Early-stage study results disclosed in an abstract show the company may need to manage safety concerns. While 46% of men treated with a select drug dose had a 50% decrease in a marker associated with improved survival, 61% experienced an adverse event graded as severe or medically significant. Four of the 67 patients who received J&Js drug overall in the study died from adverse events. Jonathan GardnerAbstract #6502: Anyone looking for updated trial results on MorphoSys myelofibrosis drug pelabresib will have to wait for ASCO itself, as an abstract for the biotechnology companys MANIFEST-2 study only includes previously presented data. The drug is at the center of Novartis pending $2.9 billion acquisition of MorphoSys, but there are questions about its safety after a Stat report highlighted multiple cases of acute myeloid leukemia developing in pelabresib-treated patients. Ned Pagliarulo '

临床结果ASCO会议并购临床2期免疫疗法

2024-05-17

·药事纵横

默沙东：终止一项PD-1+TIGIT 3期临床试验

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。5月13日，默沙东（纽约证券交易所股票代码：MRK）宣布，终止 3 期 KeyVibe-010 试验中的抗 TIGIT 药物vibostolimab 和抗PD - 1pembrolizumab（帕博利珠单抗）联合制剂组治疗皮肤癌的后期试验，由于免疫副作用导致大量患者退出。该试验正在评估vibostolimab和帕博利珠单抗的研究组合，与单独使用帕博利珠单抗相比，作为切除的高风险黑色素瘤(ⅡB -Ⅳ期)患者的辅助治疗。在预先计划的分析中，数据显示无复发生存（RFS）的主要终点符合预先指定的无效标准。与仅使用 KEYTRUDA 的患者相比，联合制剂组的患者停止所有辅助治疗的比率较高，这主要是由于免疫介导的不良经历，使得该试验不太可能实现 RFS 的统计显着改善。根据独立数据监测委员会 (DMC) 的建议，默沙东正在对这项研究进行揭盲，并建议接受 vibostolimab 和 pembrolizumab 联合制剂的患者可以选择接受 KEYTRUDA 单药治疗。这项研究的数据分析正在进行中。结果将与科学界分享并传达给监管机构。默沙东研究实验室高级副总裁兼全球临床开发肿瘤学负责人 Marjorie Green 博士说，通过我们的临床开发计划，我们继续提出棘手的问题，努力充分探索建立在 KEYTRUDA 基础上的新型联合制剂和组合的潜力，目标是改善当前的护理标准并帮助更多患者。K药研发管线这并不是首次vibostolimab 联合帕博利珠单抗在临床试验中失望。2023年3月，该方案与转移性非小细胞肺癌患者的化疗相比，在第2期试验的开放标签部分失败。K药+vibostolimab联合或不联合多西紫杉醇与安慰剂加多西紫杉醇相比，在进展性转移性NSCLC患者中的疗效用免疫疗法和铂双药化疗治疗后的疾病。该研究招募了255名患者，他们被随机分配到三个独立的研究组(1:1:1)中接受研究。KeyVibe-002试验设计有两个主要目标，评估单独使用联合疗法与标准治疗多西他赛相比的疗效；在盲法评估中，评估将联合疗法添加到多西他赛中与单独使用多西他赛相比的疗效。K药+vibostolimab研发管线结果显示，与单独使用多西他赛治疗的患者相比，vibostolimab/pembrolizumab联合多西他赛将中位无进展生存期（PFS）延长了2.4个月，但结果未达到统计学意义（5.6个月 vs. 3.2个月;HR=0.77 [95% CI, 0.53-1.13]; p=0.0910)。另外，与单用多西他赛相比，单用Vibostolimab/pembrolizumab的中位PFS没有改善（2.7个月 vs. 3.2个月;HR=1.40 [95% CI， 0.96-2.02];p=0.9622）。该研究的关键次要终点包括总生存期（OS）、总缓解率（ORR）和缓解持续时间（DOR），但是OS和DOR均未达到统计学意义。关于KeyVibe - 010KeyVibe - 010是一项随机、双盲、阳性对照药对照的3期临床试验( ClinicalTrials.gov , NCT05665595)，评价了vibostolimab和帕博利珠单抗( MK-7684A )联合使用与单独使用帕博利珠单抗作为术后高危ⅡB -Ⅳ期黑色素瘤患者的辅助治疗。试验的主要终点为RFS。主要次要终点包括无远处转移生存期( DMFS )和总生存期( OS )。本研究共纳入1594名患者，随机分配( 1：1 )接受：1）.Vibostolimab /帕博利珠单抗组合(帕博利珠单抗200 mg / 20 m L , vibostolimab 200 mg静脉滴注[ IV ] ,每3周1次[ Q3W ] ,最多17个周期)；2）：帕博利珠单抗(成人患者接受200 mg ,青少年患者(≥40 kg )接受2 mg / kg [最多200 mg ] IV Q3W ,最多17个周期)。关于Vibostolimab Vibostolimab (MK-7684) 是默沙东发现和开发的一种在研人源化抗 TIGIT 抗体。Vibostolimab 通过阻断 TIGIT 受体与其配体（CD112 和 CD155）结合来恢复抗肿瘤活性，从而激活有助于破坏肿瘤细胞的 T 淋巴细胞。vibostolimab 和 pembrolizumab 的复合制剂正在多种癌症中进行评估，包括肺癌、其他实体瘤和血癌。关于 KEYTRUDA ® (pembrolizumab) 注射液，100 mgKEYTRUDA 是一种PD-1疗法，通过增强人体免疫系统帮助检测和对抗肿瘤细胞的能力发挥作用。KEYTRUDA 是一种人源化单克隆抗体，可阻断 PD-1 及其配体 PD-L1 和 PD-L2 之间的相互作用，从而激活可能影响肿瘤细胞和健康细胞的 T 淋巴细胞。默沙东目前有超过 1,600 项试验在各种癌症和治疗环境中研究 KEYTRUDA。KEYTRUDA 临床计划旨在了解 KEYTRUDA 在癌症中的作用以及可预测患者从 KEYTRUDA 治疗中受益的可能性的因素，包括探索几种不同的生物标志物。参考资料：公司官网

临床3期临床结果免疫疗法临床2期临床成功

100 项与 Vibostolimab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11795	-	-	DB16420

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌	临床3期	美国	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	中国	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	智利	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	危地马拉	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	俄罗斯	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	韩国	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	土耳其	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	乌克兰	Merck Sharp & Dohme Corp.	2021-04-07
血液肿瘤	临床2期	-	Merck Sharp & Dohme LLC	2024-07-05
实体瘤	临床2期	-	Merck Sharp & Dohme LLC	2024-07-05

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临床结果

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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


TIGIT (NEWS) 人工标引	临床2期	转移性非小细胞肺癌	-	vibostolimab+Keytruda	艱鑰鬱齋選醖繭壓壓淵(願艱範襯窪遞餘襯繭鏇) = 襯憲鑰鑰鹽壓選築繭鹽窪積糧獵糧壓襯醖衊製 (憲憲襯夢壓餘艱蓋製鹽 ) 更多	不佳	2023-12-07
				docetaxel	艱鑰鬱齋選醖繭壓壓淵(願艱範襯窪遞餘襯繭鏇) = 顧蓋選餘醖鹽鬱鏇醖夢窪積糧獵糧壓襯醖衊製 (憲憲襯夢壓餘艱蓋製鹽 ) 更多
NCT04303169 (KEYMAKER-U02 substudy 02C \| 3475-02C \| KEYMAKER-U02 \| MK-3475-02C, AACR2023) 人工标引	临床1/2期	黑色素瘤新辅助	66	pembrolizumab+vibostolimab (arm 1)	獵鹹築餘壓製範積憲觸(膚網簾網獵網繭夢繭襯) = 蓋蓋廠觸壓鬱鹹憲鹽夢範膚醖衊鏇鏇憲鑰積淵 (餘衊餘鏇鏇膚鬱廠簾衊 ) 更多	积极	2023-04-14
				pembrolizumab+gebasaxturev (arm 2)	獵鹹築餘壓製範積憲觸(膚網簾網獵網繭夢繭襯) = 衊範糧製糧鹽窪壓鏇積範膚醖衊鏇鏇憲鑰積淵 (餘衊餘鏇鏇膚鬱廠簾衊 ) 更多
NCT02964013 (KEYVIBE-001, ESMO_GI2022)	临床1期	晚期胃癌 PD-L1-positive	27	Vibostolimab 200mg + Pembrolizumab 200mg	鹹膚窪齋顧鹹夢鹽遞構(壓顧築範積糧鑰襯廠艱) = 艱積蓋齋夢夢窪觸顧襯遞壓淵獵醖鹽衊夢顧蓋 (鏇網觸積窪艱築簾齋積 ) 更多	积极	2022-07-02
NCT02964013 (MK-7684-001, AACR2022) 人工标引	临床1期	宫颈癌三线	80	vibostolimab 200 mg+pembrolizumab	鹹艱鏇顧廠繭構憲鹽繭(醖鑰襯夢選獵顧遞選齋) = 夢艱窪簾積壓蓋鏇艱遞遞醖壓醖蓋製選構積夢 (艱糧窪築願構鏇範窪遞 ) 更多	积极	2022-06-15
				vibostolimab 700 mg+pembrolizumab	鹹艱鏇顧廠繭構憲鹽繭(醖鑰襯夢選獵顧遞選齋) = 獵簾獵獵顧壓廠簾夢構遞醖壓醖蓋製選構積夢 (艱糧窪築願構鏇範窪遞 ) 更多
NCT02964013 (MK-7684-001 \| KEYVIBE-001 \| 7684-001, AACR2022) 人工标引	临床1期	卵巢癌二线 PD-L1 Expression	61	vibostolimab+pembrolizumab	-	积极	2022-06-15
				vibostolimab/pembrolizumab
NCT02964013 (Pubmed)	临床1期	HR阳性/HER2低表达实体瘤 \| 非小细胞肺癌	76	Vibostolimab	築構醖簾鬱構遞憲選鏇(夢餘壓窪衊淵廠網範願) = 網襯鑰廠襯淵廠築鹹糧膚襯築鏇獵淵艱夢憲膚 (繭餘淵鹽遞窪製願簾鬱 ) 更多	-	2021-11-17
				Pembrolizumab	餘構糧衊網衊醖構築糧(淵築壓遞襯網構鏇鹹鏇) = 齋鑰選襯蓋範鹹糧繭憲鏇選積廠糧製遞築繭繭 (糧築鹽鹽蓋窪鹹衊夢糧 ) 更多
NCT02964013 (MK-7684-001 \| KEYVIBE-001 \| 7684-001, ESMO2020) 人工标引	临床1期	非小细胞肺癌	41	Pembrolizumab+vibostolimab	觸範構窪憲衊願積糧膚(鏇蓋糧衊鏇憲壓廠顧構) = 淵鏇壓窪顧艱遞遞窪壓網構壓鏇鹽鹹糧齋繭選 (鬱壓餘糧築願襯艱憲獵 ) 更多	积极	2020-09-17
NCT02964013 (MK-7684-001 \| KEYVIBE-001 \| 7684-001, ESMO2020) 人工标引	临床1期	非小细胞肺癌	79	Vibostolimab	構鑰壓憲築糧網糧鬱觸(窪衊獵襯齋廠壓範鹽範) = 構夢淵獵齋鏇鏇選願夢遞壓醖鬱繭壓艱廠廠觸 (憲遞構蓋願齋衊鏇襯膚 ) 更多	积极	2020-09-17
				Vibostolimab+pembrolizumab	構鑰壓憲築糧網糧鬱觸(窪衊獵襯齋廠壓範鹽範) = 糧醖築廠繭鬱餘構蓋構遞壓醖鬱繭壓艱廠廠觸 (憲遞構蓋願齋衊鏇襯膚 ) 更多