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). 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2025-01-15

申办/合作机构

Merck Sharp & Dohme LLC

NCT04303169

/ Active, not 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 02C

Substudy 02C 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 02C is to evaluate the safety and efficacy of investigational treatment arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.
Arm 1: Pembrolizumab + Vibostolimab, Arm 2: Pembrolizumab + Gebasaxturev, and Arm 3: Pembrolizumab were added in the base protocol on 13-Nov-2019, and enrollment into those arms has been completed. Arm 4: Pembrolizumab + MK-4830 was added in Amendment 04 on 20-Dec-2021, and enrollment into that arm has been completed. Arm 5: Favezelimab + Pembrolizumab and Arm 6: Pembrolizumab + all-trans retinoic acid (ATRA) were added in Amendment 06 on 25-Jun-2022, and enrollment is ongoing.

开始日期2020-06-26

申办/合作机构

Merck Sharp & Dohme LLC

NCT04165070

/ Recruiting临床1/2期

KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC.
This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

开始日期2019-12-19

申办/合作机构

Merck Sharp & Dohme Corp.

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100 项与维博利单抗相关的临床结果

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100 项与维博利单抗相关的转化医学

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100 项与维博利单抗相关的专利（医药）

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项与维博利单抗相关的文献（医药）

2025-01-01·NATURE MEDICINE

Neoadjuvant anti-PD-1 alone or in combination with anti-TIGIT or an oncolytic virus in resectable stage IIIB–D melanoma: a phase 1/2 trial

Article

作者: Menzies, Alexander M ; Hill, Andrew ; Long, Georgina V ; Grob, Jean-Jacques ; Khattak, Muhammad A ; Robert, Caroline ; Dummer, Reinhard ; Shapira-Frommer, Ronnie ; Mehmi, Inderjit ; Meyer, Nicolas ; Fukunaga-Kalabis, Mizuho ; Portnoy, David C ; Lebbe, Celeste ; Tetzlaff, Michael T ; Bar-Sela, Gil ; Cohen, Jonathan ; Krepler, Clemens ; Webber, Andrea L ; Ren, Yixin ; Scolyer, Richard A ; Taube, Janis M

Neoadjuvant immunotherapies have shown antitumor activity in melanoma. Substudy 02C of the global, rolling-arm, phase 1/2, adaptive-design KEYMAKER-U02 trial is evaluating neoadjuvant pembrolizumab (anti-PD-1) alone or in combination, followed by adjuvant pembrolizumab, for stage IIIB-D melanoma. Here we report results from the first three arms: pembrolizumab plus vibostolimab (anti-TIGIT), pembrolizumab plus gebasaxturev (coxsackievirus A21) and pembrolizumab monotherapy. Pathologic complete responses occurred in 10 of 26 patients (38%) with pembrolizumab plus vibostolimab, 7 of 25 (28%) with pembrolizumab plus gebasaxturev and 6 of 15 (40%) with pembrolizumab monotherapy. Major pathologic responses occurred in 13 (50%), 10 (40%) and 7 (47%) patients, respectively. Safety was manageable. Treatment-related adverse events occurred in 24 of 26 patients (92%) with pembrolizumab plus vibostolimab, 21 of 25 (84%) with pembrolizumab plus gebasaxturev and 12 of 15 (80%) with pembrolizumab monotherapy; grade 3 or 4 treatment-related adverse events occurred in 2 (8%), 7 (28%) and 1 (7%) patient in each arm, respectively. No deaths due to adverse events occurred. Exploratory objective responses per RECIST v1.1 were observed in 13 (50%), 8 (32%) and 4 (27%) patients, in each arm, respectively. In a post hoc analysis, scores for tumor mutational burden and an 18-gene T cell-inflamed gene expression profile were generally higher in patients with major pathologic response. Longer follow-up will provide insight into the incremental benefit of combining neoadjuvant pembrolizumab with other therapies in stage IIIB-D melanoma. ClinicalTrials.gov registration: NCT04303169 .

2024-08-26·Future Oncology

The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies

Article

作者: Ahn, Myung-Ju ; Peters, Solange ; Shouse, Geoffrey ; Lugowska, Iwona ; Garassino, Marina C. ; Zhao, Bin ; Sands, Jacob ; Niu, Jiaxin ; Keenan, Tanya ; Perets, Ruth ; Healy, Jane ; Shapira-Frommer, Ronnie

Vibostolimab, a humanized IgG1 monoclonal antibody, blocks the interaction between TIGIT and its ligands, preventing the immunosuppressive effects of TIGIT. The addition of vibostolimab to the PD-1 inhibitor pembrolizumab has shown promising antitumor activity, warranting further exploration of vibostolimab as a potential therapeutic option. The KEYVIBE program consists of nine trials that will evaluate the safety and efficacy of vibostolimab monotherapy and vibostolimab-based combination therapy in advanced solid tumors and hematological malignancies. These studies will also evaluate coformulated immunotherapy addressing issues that occur with the sequential administration of immunotherapy. The KEYVIBE program will provide further insight into the clinical utility of vibostolimab-based therapy across multiple indications and various stages of disease.

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.

124

项与维博利单抗相关的新闻（医药）

2025-05-14

·Pharmaceutical Technology

GSK and iTeos drop anti-TIGIT drug following trial failure

GSK and iTeos have said they are stopping all development programmes for their anti-TIGIT antibody belrestotug. Image credit: Shutterstock / FON’s Fasai. GSK and iTeos are the latest companies to scrap a jointly developed anti-TIGIT drug after it failed to demonstrate a meaningful benefit in two Phase II trials. Belrestotug, a human IgG1 antibody created to bind with high-affinity T cell immunoglobulin and ITIM domains (TIGIT), was being developed as part of a partnership harnessed between the companies in June 2021 . The companies announced on 13 May that they were slashing the programme after receiving new interim analyses from the Phase II GALAXIES Lung-201 (NCT05565378) and GALAXIES H&N-202 (NCT06062420) studies, which did not meet their efficacy endpoints. Both trials were investigating the drug in combination with the PD-1 monoclonal antibody Jemperli (dostarlimab). However, the GALAXIES Lung-201 study was in patients with previously untreated, advanced/metastatic non-small-cell lung cancer (NSCLC). Meanwhile, the GALAXIES H&N-202 trial was in patients with PD-L1 positive recurrent/metastatic squamous cell carcinoma of the head and neck. iTeos reported that while the GALAXIES Lung-201 trial demonstrated clinically meaningful improvements in the primary endpoint of objective response rate (ORR), however, the analysis did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progression-free survival (PFS). Analysis from the GALAXIES H&N-202 trial showed a trend below the meaningful threshold for ORR in the combination cohort. In a company statement, GSK says that due to the failures, the collaboration and all belrestotug study cohorts are ending. iTeos clarified that this includes enrolment in the ongoing GALAXIES Lung-301 Phase III trial. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence iTeos’ president and chief executive officer Dr Michel Detheux said: “We are truly disappointed by the results from GALAXIES Lung-201. Following the analysis of the TIGIT data generated to date with GSK, we have made the mutual decision to discontinue the development of all ongoing TIGIT studies.” GSK joins pharma giants dropping anti-TIGIT drugs The news may come as a shock to the oncology field, as GSK and iTeos provided the first data for the GALAXIES Lung-201 study at the European Society for Medical Oncology (ESMO) Congress 2024 last September. The data seemed to show a positive trend with an ORR of between 63.3% and 76.7% versus 37.5% for Jemperli as a monotherapy. The mechanism has proven challenging, with GSK and iTeos becoming the latest companies to terminate an anti-TIGIT asset. Last month, BeiGene announced it was terminating development of ociperlimab , which it had been manufacturing as a treatment for lung cancer. In December 2024, MSD scrapped the development of its anti-TIGIT antibody vibostolimab after the Phase III KeyVibe-003 and KeyVibe-007 trials met the pre-specified futility criteria for the primary endpoint of overall survival (OS) in patients with NSCLC. The company stopped the KeyVibe-008 trial last year . In November 2024, Roche reported a failure with its candidate tiragolumab , which was being trialled in the Phase III Skyscraper-01 study. This came after earlier setbacks in the SKYSCRAPER-02 (NCT04256421) study and the Phase II/III SKYSCRAPER-06 (NCT04619797) trial. Some anti-TIGIT programmes are still steaming ahead, including one by Gilead and Arcus Biosciences; who are investigating domvanalimab , and another by AstraZeneca with its PD-1/TIGIT bispecific antibody rilvegostomig .

临床2期临床3期临床1期临床终止临床结果

2025-05-14

·BioSpace

GSK, iTeos Abandon TIGIT Therapy, Adding to Long List of Recent Class Failures

iStock, nndanko Belrestotug showed underwhelming efficacy outcomes in mid-stage studies of non-small cell lung cancer and head and neck squamous cell carcinoma. GSK and Massachusetts-based partner iTeos Therapeutics will no longer advance their investigational TIGIT therapy belrestotug following disappointing mid-stage results, GSK announced on Tuesday. The decision adds another therapy to the spate of failed TIGIT therapies across the industry. “The collaboration [with iTeos] and all belrestotug-containing study cohorts are ending,” GSK wrote in its news release. The decision to discontinue the development of belrestotug was “mutual,” iTeos CEO Michel Detheux said in a statement alongside the biotech’s own announcement. In the aftermath of belrestotug’s discontinuation—and of losing a powerhouse partner—iTeos is “taking immediate steps” to shore up its financial position. The biotech on Tuesday kicked off a “targeted” strategic review of its business to identify opportunities to maximize capital and value to shareholders, as per its press announcement. GSK and iTeos were studying belrestotug in the Phase II GALAXIES Lung-201 study in non-small cell lung cancer (NSCLC). Topline results from this trial, reported Tuesday, showed that while the TIGIT therapy did meet its primary endpoint of objective response rate, it was unable to elicit “clinically meaningful improvements in . . . progression-free survival,” a key secondary outcome of the study, according to iTeos’ release. The partners were also running the GALAXIES H&N-202 Phase II study in head and neck squamous cell carcinoma. GALAXIES H&N-202 also delivered disappointing results, with belrestotug showing a “trend below the meaningful threshold for” objective response rate. GALAXIES Lung-201 and GALAXIES H&N-202 paired belrestotug with GSK’s PD-1 blocker Jemperli and compared the combo against Jemperli alone. The companies did not provide specific figures for either study on Tuesday, though Detheux noted that “it is important to share these data with the scientific community at an upcoming medical meeting.” GSK and iTeos came together for this collaboration in 2021 , in a deal that had GSK paying iTeos $625 up front and up to $1.45 billion in downstream milestone payments. Belrestotug joins the growing group of TIGIT treatments that have been shelved over the past year, highlighting the difficulties of developing therapies in this class. Last month, for instance, BeiGene announced that it would no longer pour money into its anti-TIGIT antibody ociperlimab, which it had been assessing for NSCLC. An independent data monitoring committee found that the Phase III AdvanTIG-302 trial was “unlikely to meet the primary endpoint of overall survival.” In July 2024, Roche likewise dumped its TIGIT candidate tiragolumab after disappointing data from the Phase II/III SKYSCRAPER-06 trial in NSCLC. This followed Merck’s May 2024 discontinuation of a late-stage study for the anti-TIGIT treatment vibostolimab, which it was combining with its blockbuster Keytruda as a treatment for melanoma.

临床2期临床3期临床结果临床失败临床终止

2025-04-21

·药事纵横

免疫治疗的下一个“黄金靶点”为何集体哑火？盘点那些年我们追过的TIGIT

TIGIT作为癌症免疫治疗领域的热门靶点，一度被视为“下一个PD-1”，吸引了罗氏、默沙东、阿斯利康、百济神州等多家药企的重金投入。但现实却给了它们重重一击，近几年关于TIGIT靶点的研究接连折戟，2025年4月3日，中国创新药企百济神州宣布终止其TIGIT抗体药物欧司珀利单抗（Ociperlimab）的肺癌适应症临床开发。此前，默沙东、罗氏、百时美施贵宝等跨国药企已相继终止同类项目，曾被寄予厚望的TIGIT靶点，如今深陷临床失败潮......TIGIT靶点为何被寄予厚望？2009年，罗氏基因泰克团队首次解析了TIGIT（T cell immunoreceptor with Ig and ITIM domains）的分子机制，其这个拥有免疫球蛋白样结构域和ITIM抑制性基序的靶点，被证实能够通过与CD155等配体结合，调控T细胞和NK细胞的活性。这种“双重免疫激活”的理论模型，让TIGIT迅速成为肿瘤免疫领域的焦点。在PD-1/L1抑制剂大获成功的背景下，TIGIT迅速被捧为“下一个百亿赛道”。2016年罗氏启动Tiragolumab临床试验时，行业预测TIGIT药物市场规模将在2030年突破50亿美元。默沙东押注Vibostolimab，BMS豪掷2亿美元引进AGEN1777，百济神州更是不惜投入20亿人民币推进欧司珀利单抗。到2024年，全球已有超过80个TIGIT相关临床项目，覆盖肺癌、肝癌、黑色素瘤等主要癌种。那些年我们追过的TIGIT药物罗氏的TiragolumabTiragolumab的临床研发之路充满波折。2022年3月，III期研究SHYSCRAPER-02在广泛期小细胞肺癌（ES-SCLC）一线治疗中，Tiragolumab联合阿替利珠单抗及化疗方案未能显著改善无进展生存期（PFS）和总生存期（OS），首战告负。随后在同年5月，针对PD-L1高表达非小细胞肺癌（NSCLC）的III期SKYSCRAPER-01研究初步分析显示，虽然联合治疗组的中位PFS（15.2月 vs 14.0月）与对照组（阿替利珠单抗单药）相比未达统计学差异，但基于OS数据尚未成熟，研发方罗氏决定继续推进研究。2023年8月的中期分析：联合治疗组展现出22.9个月的中位OS（对照组16.7个月），风险比（HR）降至0.81，但这一差异仍未跨越统计学显著性阈值，使得市场对TIGIT靶点的预期开始动摇。2024年7月公布的SKYSCRAPER-06研究结果显示，在非鳞状NSCLC一线治疗中，Tiragolumab联合方案不仅未能改善疗效（PFS HR=1.27，OS HR=1.33），其生存数据甚至显著劣于阿替利珠单抗联合化疗的对照组。最终在2024年11月，SKYSCRAPER-01研究的最终分析确认OS未达主要终点，正式宣告Tiragolumab在肺癌一线治疗领域的全线失利，这一系列挫折也为TIGIT抑制剂的研发前景蒙上浓重阴影。默沙东的Vibostolimab默沙东在TIGIT靶点药物Vibostolimab与王牌PD-1抑制剂K药（Keytruda）的联用探索上遭遇了连环挫折。这个项目最初在2023年3月就显出颓势，当时公布的II期KeyVibe-002临床试验结果显示，针对非小细胞肺癌二线治疗，联合疗法组的中位无进展生存期（2.7个月）甚至不如传统化疗药物多西他赛（3.2个月），首战告负。进入2024年后，噩耗接踵而至：5月因严重免疫相关不良反应紧急叫停黑色素瘤辅助治疗的III期KeyVibe-010研究；8月针对小细胞肺癌一线治疗的III期KeyVibe-008试验又因总生存期未达预期且存在安全隐患宣告终止；最终在12月，默沙东宣布全面停止Vibostolimab的临床开发计划，所有肺癌适应症研发线集体搁浅，标志着其TIGIT管线彻底崩塌。虽然期间默沙东尝试通过收购抗体偶联药物（ADC）和T细胞衔接器技术来补充小细胞肺癌产品线，但TIGIT+PD-1的联合疗法策略已完全退出历史舞台。至此，这家制药巨头成为全球首个全面撤离TIGIT赛道的大型药企，转而将重心投向双特异性抗体等新型免疫治疗方向。百时美施贵宝（BMS）的AGEN17772021年5月，BMS宣布以2亿美元首付款加13.6亿美元潜在里程金，收购Agenus公司临床前阶段的TIGIT/CD96双抗药物AGEN1777。这个时期TIGIT靶点正因罗氏早期临床数据引发行业热潮，BMS希望通过差异化布局抢占先机。2023年2月，BMS宣布终止其自主研发的TIGIT单抗BMS-986207的II期临床试验。该试验探索了BMS-986207与PD-1抑制剂Opdivo（O药）、CTLA-4抑制剂Yervoy（Y药）的三联疗法，但因观察到联合用药的毒性问题（具体细节未披露），出于安全性考虑决定终止开发，这一失败让BMS在TIGIT领域的自研管线受挫。2024年5月，BMS进一步收缩TIGIT布局，将此前重金引入的AGEN1777双抗退回给Agenus。退回原因可能与临床数据不及预期、市场竞争风险及公司战略调整有关。至此，BMS完全退出了TIGIT领域的研发竞争。百济神州的欧司珀利单抗2020年，百济神州开始推进其TIGIT抗体药物欧司珀利单抗（Ociperlimab，代号BGB-A1217）的研发。临床前数据显示，该药物效力比罗氏的同类产品Tiragolumab高出4倍，并与自家PD-1药物替雷利珠单抗联用进入Ⅰ期临床试验。2021年12月，百济与诺华达成重磅合作，以29亿美元的交易金额（含预付款、里程碑付款及销售分成）授权诺华负责欧司珀利单抗在欧美等多国的商业化，成为当时国产创新药海外授权的标杆案例。没想到这段跨国合作仅维持了20个月就宣告破裂。2023年7月，双方宣布终止协议，诺华退出开发，百济不得不收回权益单干。就在协议终止前一个月，百济神州悄悄暂停了该药联合疗法在肝癌领域的Ⅱ期试验。业内人士普遍认为，这波操作与罗氏TIGIT药物在肺癌Ⅲ期临床试验折戟有关系当时整个TIGIT靶点研发赛道都遭遇了信任危机。苦撑两年后，坏消息还是来了。2025年4月，独立数据监查委员会经过评估，认为试验数据难以达到预设的总生存期目标。至此，这个累计烧掉20.9亿人民币的重磅项目被迫画上句号。为何TIGIT走不出实验室？面对TIGIT靶点的集体溃败，大家开始重新审视这个曾被过度美化的机制。TIGIT并非孤立存在的靶点，它与CD226、PVR等配体构成动态平衡网络。当药物阻断TIGIT通路时，CD226的激活可能引发代偿性免疫抑制，这种“按下葫芦浮起瓢”的效应让单抗药物难以精准调控免疫反应。另一个致命问题在于患者筛选。现有临床试验大多沿用PD-L1表达水平作为入组标准，但TIGIT的疗效可能与完全不同的生物标志物相关，或许是由于缺乏成熟的检测手段和统一标准，药企至今无法在III期试验中精准锁定受益人群。联合疗法的增效神话也在现实中破碎。早期研究认为，TIGIT抑制剂与PD-1药物的联用能产生“1+1>2”的效果，但大规模临床试验揭示的却是另一番图景。默沙东的Vibostolimab与帕博利珠单抗联用时，3级以上免疫相关不良反应发生率高达38%，是PD-1单药治疗的两倍。讽刺的是在百济神州的试验中，联合治疗组部分患者的肿瘤进展速度反而加快。TIGIT靶点的溃败也给中国创新药行业上了沉重一课。百济神州在TIGIT项目上累计投入的20.9亿元，相当于其2024年研发总支出的31%。尽管代价惨痛，但全球化临床团队的建设、与FDA沟通的经验、以及应对研发危机的管理体系，都成为企业转型的隐形资产。今天对TIGIT靶点的及时撤退，是为了明天更聪明的进攻。信息来源：[1]Chauvin, J. M., & Zarour, H. M. (2020). TIGIT in cancer immunotherapy. Journal for ImmunoTherapy of Cancer, 8(2), e000957. https://doi-org.libproxy1.nus.edu.sg/10.1136/jitc-2020-000957[2]Roche. (2024, November 15). Final analysis of SKYSCRAPER-01 study in PD-L1-high metastatic non-small cell lung cancer [Press release]. https://www.roche.com/investors/updates/inv-update-2024-11-15[3]Merck & Co. (2024, December 10).Merck provides update on vibostolimab clinical development program [Press release].https://www-merck-com.libproxy1.nus.edu.sg/news/merck-provides-update-on-vibostolimab[4]Agenus Inc. (2024, May 3). Agenus regains global rights to AGEN1777 from Bristol Myers Squibb [Press release].https://investagenus.mediaroom.com/2024-05-03[5]BeiGene. (2025, April 3). BeiGene discontinues ociperlimab development in lung cancer [Press release]. https://www.beigene.com/news-media/press-releases/detail/435药事纵横投稿须知：稿费已上调，欢迎投稿

免疫疗法临床3期细胞疗法临床结果

100 项与维博利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11795	-	-	DB16420

研发状态

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
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
Turcot综合征	临床2期	美国	Merck Sharp & Dohme LLC	2025-01-15
Turcot综合征	临床2期	中国台湾	Merck Sharp & Dohme LLC	2025-01-15

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临床结果

适应症

分期

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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


NCT04303169 (KEYMAKER-U02, ESMO2024) 人工标引	临床1/2期	黑色素瘤	117	Pembrolizumab + Vibostolimab	夢憲壓窪餘遞餘觸獵鹽(襯餘淵構鏇鑰簾廠壓衊) = 觸築壓獵壓築齋觸淵築鹹膚網醖積鏇願鑰醖積 (衊製蓋蓋膚廠廠壓遞齋 ) 更多	积极	2024-09-14
				Pembrolizumab + Gebasaxturev	夢憲壓窪餘遞餘觸獵鹽(襯餘淵構鏇鑰簾廠壓衊) = 獵鬱觸鬱膚憲淵製鬱餘鹹膚網醖積鏇願鑰醖積 (衊製蓋蓋膚廠廠壓遞齋 ) 更多
TIGIT (NEWS) 人工标引	临床2期	转移性非小细胞肺癌	-	vibostolimab+Keytruda	鑰淵艱窪範齋獵衊獵廠(廠壓鏇鹽範鬱範遞夢醖) = 構選醖鏇蓋選構窪鏇鑰範顧製艱積襯膚鹹壓築 (糧鹽蓋鬱獵鹽遞鑰鑰夢 ) 更多	不佳	2023-12-07
				docetaxel	鑰淵艱窪範齋獵衊獵廠(廠壓鏇鹽範鬱範遞夢醖) = 齋襯窪鏇鹹壓艱鹹範衊範顧製艱積襯膚鹹壓築 (糧鹽蓋鬱獵鹽遞鑰鑰夢 ) 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)	願網選糧觸廠夢選淵壓(醖願鬱膚範鏇鹹糧衊壓) = 艱範衊鑰壓窪築窪淵壓簾築構夢範觸廠築繭繭 (築築廠鏇衊積鑰築構繭 ) 更多	积极	2023-04-14
				pembrolizumab+gebasaxturev (arm 2)	願網選糧觸廠夢選淵壓(醖願鬱膚範鏇鹹糧衊壓) = 鏇築製簾築願衊鏇衊觸簾築構夢範觸廠築繭繭 (築築廠鏇衊積鑰築構繭 ) 更多
NCT02964013 (KEYVIBE-001, ESMO_GI2022)	临床1期	晚期胃癌 PD-L1-positive	27	Vibostolimab 200mg + Pembrolizumab 200mg	遞窪遞鏇範範遞鑰觸淵(簾餘顧衊願醖選鏇積鹽) = 憲製醖築繭顧鹹鏇夢夢鏇廠窪餘醖窪淵衊觸餘 (壓壓壓鏇壓構積構繭顧 ) 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	鹹範憲鬱窪夢鹹壓夢觸(膚醖製鏇築蓋鬱築壓築) = 餘觸網淵鹹夢遞餘繭淵鬱積襯築網遞鬱襯蓋觸 (鹹窪窪鏇醖憲淵鹹獵廠 ) 更多	积极	2022-06-15
				vibostolimab 700 mg+pembrolizumab	鹹範憲鬱窪夢鹹壓夢觸(膚醖製鏇築蓋鬱築壓築) = 壓憲鏇範遞製窪遞鏇窪鬱積襯築網遞鬱襯蓋觸 (鹹窪窪鏇醖憲淵鹹獵廠 ) 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 (MK-7684-001 \| KEYVIBE-001 \| 7684-001, ESMO2020) 人工标引	临床1期	非小细胞肺癌	79	Vibostolimab	鹽鑰構選願繭衊觸簾餘(製鏇憲鹽夢鹽繭築願膚) = 鏇艱糧簾繭醖範築鑰蓋襯顧鬱糧繭壓選壓獵壓 (觸憲觸獵糧膚構窪艱壓 ) 更多	积极	2020-09-17
				Vibostolimab+pembrolizumab	鹽鑰構選願繭衊觸簾餘(製鏇憲鹽夢鹽繭築願膚) = 糧蓋觸鬱顧襯構積築淵襯顧鬱糧繭壓選壓獵壓 (觸憲觸獵糧膚構窪艱壓 ) 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	糧顧築鏇構顧鹽襯鑰衊(願顧網艱網簾艱衊襯觸) = 鏇鏇夢廠範鹽衊觸顧觸鏇製蓋夢製願觸積夢願 (範網鬱窪襯鑰襯簾齋艱 ) 更多	积极	2020-09-17