帕博利珠单抗(Pembrolizumab) - 药物靶点：PD-1_在研适应症：不可切除的肝细胞癌，恶性胸膜间皮瘤，不可切除的尿路上皮癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Lambrolizumab、Pembrolizumab (Genetical Recombination)、Pembrolizumab (genetical recombination) (JAN)

+ [10]

靶点

PD-1

作用方式

抑制剂

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤免疫系统疾病感染+ [13]

在研适应症

不可切除的肝细胞癌恶性胸膜间皮瘤不可切除的尿路上皮癌+ [564]

非在研适应症

转移性腺癌腺病毒科感染晚期结直肠腺癌+ [75]

原研机构

Merck & Co., Inc.

在研机构

MSD KK

Astellas Pharma Global Development, Inc.

德琪医药有限公司

+ [92]

非在研机构

Targovax Oy

Evelo Biosciences, Inc.

Oncxerna Therapeutics, Inc.

+ [22]

权益机构

Nektar Therapeutics

NeoImmuneTech, Inc.

Canada Pension Plan Investment Board

+ [76]

最高研发阶段批准上市

首次获批日期

美国 (2014-09-04),

黑色素瘤

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)、优先药物（PRIME） (欧盟)、附条件批准 (中国)、孤儿药 (日本)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、优先审评 (中国)

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结构/序列

Sequence Code 93660H

来源: *****

Sequence Code 93670L

来源: *****

关联

2,429

项与帕博利珠单抗相关的临床试验

NCT07037004

/ Not yet recruiting临床2期IIT

Impact of Microbiome Modulation With CBM588 in Combination With Pembrolizumab for Adjuvant Therapy of High-Risk, Resected Renal Cell Carcinoma (RCC)

This phase II trial compares the effect of adding a probiotic called CBM588 to pembrolizumab versus pembrolizumab alone in preventing return of disease (recurrence) after surgery for patients with renal cell cancer. Pembrolizumab is an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies such as pembrolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for the treatment of renal cell cancer after surgery. Research has shown that changes to the composition of the healthy bacteria in the body (the microbiome), may improve a patient's response to treatment with immunotherapy. CBM588, a probiotic supplement containing a bacteria called Clostridium butyricum, has been shown to improve outcomes in patients treated with immunotherapy for other types of cancer. Adding CBM588 to treatment with pembrolizumab after surgery may cause changes in the microbiome that improve patient response to treatment and reduce disease recurrence, compared to pembrolizumab alone.

开始日期2026-05-04

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06543576

/ Not yet recruiting临床1/2期IIT

A Prospective Cohort Study of Integrating Radiotherapy Into Chemotherapy With Pembrolizumab and Bevacizumab in Newly Diagnosed Stage IVB Cervical Cancer

This phase I/II trial tests the safety and effectiveness of receiving external beam radiation therapy (EBRT) and brachytherapy along with chemotherapy, consisting of cisplatin and paclitaxel, and immunotherapy, consisting of bevacizumab and pembrolizumab, for the treatment of patients with stage IVB cervical cancer. EBRT is type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving EBRT and brachytherapy along with chemotherapy and immunotherapy may be a safe and effective way to treat patients with stage IVB cervical cancer.

开始日期2026-01-31

申办/合作机构

Jonsson Comprehensive Cancer Center

[+1]

NCT06669572

/ Not yet recruiting临床2期IIT

A Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and/or Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.

The purpose of this study is to gather information on the safety and effectiveness of lenvatinib combined with pembrolizumab in anal/rectal cancer that has spread to other parts of the body and will not respond to standard care.

开始日期2026-01-13

申办/合作机构

The University of Chicago

100 项与帕博利珠单抗相关的临床结果

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100 项与帕博利珠单抗相关的转化医学

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100 项与帕博利珠单抗相关的专利（医药）

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10,497

项与帕博利珠单抗相关的文献（医药）

2026-01-01·TALANTA

Biosimilarity and advanced structural characterization of monoclonal antibodies charge variants using capillary zone electrophoresis and mass spectrometry

Article

作者: Joomun, Rania ; Gahoual, Rabah ; Alez-Martin, Lola ; François, Yannis-Nicolas ; Mignet, Nathalie ; Houzé, Pascal

Monoclonal antibodies (mAbs) structural complexity arises from their macromolecular nature and their propensity to undergo post-translational modifications (PTM), potentially leading to the formation of charge variants. Capillary zone electrophoresis (CZE) showed to be particularly relevant for their analysis, however the selectivity provided by CZE separation is not completely elucidated. In this work, CZE-UV analysis was used to characterize charge variants for biosimilars products corresponding to infliximab. Results demonstrated the possibility to identify faint variations between the different products showing its applicability to contribute to mAbs biosimilarity assessment. Enzymatic treatment allowed to attribute the origin of infliximab charge variants. CZE-UV analysis of pembrolizumab showed that none of the five charge variants separated were originating from C-terminal lysine residues and/or N-glycans. To enable further identification, an analytical strategy was developed to achieve CZE-UV fraction collection and enrichment of mAb charge variants followed by systematic offline characterization in CE coupled to tandem mass spectrometry (MS/MS). CE-MS/MS experiments allowed the identification of different types of PTMs such as N-terminal pyroglutamic acid formation and asparagine deamidation for charge variant fractions correlated with decreased mobility. In addition, for the first time succinimide intermediate formation could be successfully characterized using CE-MS/MS data, which could be correlated to increased mobility. Thus, the CZE-UV separation resulted from the synergistic effect of several simultaneous PTMs affecting the apparent mobilities of the charge variants. As a consequence, experiments illustrated the relevance and potential of intact mAbs analysis using CZE-UV to provide an overview of the structural diversity of therapeutic mAbs.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

The cost-effectiveness of treatment for high-risk, early-stage, triple-negative breast cancer in Egypt: an analysis of neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant single-agent pembrolizumab

Article

作者: Haiderali, Amin ; Huang, Min ; Pöllinger, Bernadette ; Abdelaziz, Ahmed H. ; Kassem, Loay ; Akyol Ersoy, Burcu ; Elsisi, Gihan Hamdy

OBJECTIVE:

The cost-effectiveness of neoadjuvant pembrolizumab + chemotherapy followed by adjuvant pembrolizumab compared to neoadjuvant chemotherapy plus placebo followed by adjuvant placebo was assessed in high-risk, early-stage, triple-negative breast cancer patients from an Egyptian societal perspective over a lifetime horizon.

METHODS:

A 4-state Markov cohort model was developed to compare the cost-effectiveness of pembrolizumab + chemotherapy/pembrolizumab vs chemotherapy alone for the treatment of high-risk, early-stage, triple-negative breast cancer. The model simulated the clinical course of high-risk, early-stage, triple-negative breast cancer across four health states: event-free survival, locoregional recurrence, distant metastasis, and death. Clinical inputs for the simulation were derived from modeling of efficacy and safety data collected in the KEYNOTE-522 trial. Direct medical costs and indirect costs were reported in 2022 Egyptian pounds (EGP) and converted to US dollars ($). Probabilistic and deterministic sensitivity analyses were conducted to assess the robustness of model results.

RESULTS:

Compared with chemotherapy alone, pembrolizumab + chemotherapy/pembrolizumab led to expected gains of 2.92 life years and 2.25 quality-adjusted life years, respectively, while increasing overall treatment costs by EGP 491,695 ($102,436). Incremental costs per year gained were EGP 218,285 ($45,476) per quality-adjusted life year and EGP 168,223 ($35,046) per life year, both of which were lower than the 2022 Egyptian cost-effectiveness threshold of EGP 398,439 ($83,008). The findings of sensitivity analyses indicated that the model was robust across a range of inputs and assumptions.

CONCLUSIONS:

In Egypt, pembrolizumab + chemotherapy/pembrolizumab is a cost-effective treatment for high-risk, early-stage, triple-negative breast cancer when considering health-related quality-of-life and years of life gained.

2025-12-31·OncoImmunology

Clinical impact of cancer cachexia on the outcome of patients with non-small cell lung cancer with PD-L1 tumor proportion scores of ≥50% receiving pembrolizumab monotherapy versus immune checkpoint inhibitor with chemotherapy

Article

作者: Katayama, Yuki ; Hasegawa, Isao ; Kijima, Takashi ; Kawachi, Hayato ; Iwasaku, Masahiro ; Date, Koji ; Yamada, Tadaaki ; Shimose, Takayuki ; Nakao, Akira ; Okada, Asuka ; Harada, Taishi ; Tokuda, Shinsaku ; Morimoto, Kenji ; Nishioka, Naoya ; Tamiya, Motohiro ; Tanimura, Keiko ; Shiotsu, Shinsuke ; Goto, Yasuhiro ; Takayama, Koichi ; Tamiya, Nobuyo ; Negi, Yoshiki ; Chihara, Yusuke ; Takeda, Takayuki

This retrospective, multicenter cohort study aimed to determine whether cancer cachexia serves as a biomarker for determining the most effective treatment for patients having non-small-cell lung cancer (NSCLC) with high programmed death ligand 1 (PD-L1) expression treated with immune checkpoint inhibitors (ICIs) alone or combined with chemotherapy (ICI/chemotherapy). We included 411 patients with advanced NSCLC with a PD-L1 tumor proportion score of ≥50%. The patients were treated with pembrolizumab monotherapy or ICI/chemotherapy. Cancer cachexia was defined as a weight loss of >5% of the total body weight or a body mass index of <20 kg/m² coupled with an additional weight loss of >2% within 6 months before starting treatment. Eighty-five (21%) patients met the cancer cachexia criteria. Overall survival (OS) was significantly shorter in patients with cachexia than in those without cachexia in both the pembrolizumab monotherapy group (17.2 vs. 35.8 months, p < 0.001) and the ICI/chemotherapy group (27.0 months vs. not reached, p = 0.044). However, after stratifying by cancer cachexia status, no significant difference in OS was observed between the pembrolizumab monotherapy and chemoimmunotherapy groups, regardless of cachexia. In conclusion, ICI/chemotherapy offers limited benefits for NSCLC patients with high PD-L1 expression and concurrent cancer cachexia. Considering the frailty associated with cachexia, ICI monotherapy may be preferred to ICI/chemotherapy for these patients. New interventions that can better address the negative prognostic impact of cachexia in patients treated using ICIs with or without chemotherapy remain warranted.

8,452

项与帕博利珠单抗相关的新闻（医药）

14 小时之前

·今日头条

肺癌治疗大进展！新抗原疫苗联合化疗+抗PD-1，肿瘤缩小超30%！

针对PD-1/PD-L1的免疫检查点抑制剂已成为非小细胞肺癌（NSCLC）的一线标准治疗，可联合化疗或单独使用。尽管这一领域进展显著，但仍需更多治疗选择以进一步延长患者生存期——而在化疗与帕博利珠单抗方案中加入新抗原疫苗，为诱导和扩大肿瘤特异性免疫反应提供了新可能。《Cancer Cell》报道的一项Ib期临床试验（NCT03380871），探索了个体化新抗原疫苗NEO-PV-01联合培美曲塞、卡铂及帕博利珠单抗用于晚期非鳞状NSCLC的一线治疗。结果证实，这一联合方案在一线非鳞状NSCLC中兼具可行性与安全性，为患者带来了全新治疗选择。我们也期待未来，更多患者或将凭借这样的联合疗法突破生存瓶颈，迎来更长、更有质量的生命时光！ ▲截图源自“Cancer Cell” 肺癌NEO-PV-01疫苗让疗效和生存期双双提升，69%患者肿瘤缓解，生存期延长至20个月该研究共纳入38例晚期非鳞状非小细胞肺癌（NSCLC）患者，最短随访期为24个月。患者先接受帕博利珠单抗+培美曲塞+卡铂联合治疗，随后在四个不同解剖位置肌肉注射NEO-PV-01疫苗；其中，所有接受至少一剂帕博利珠单抗治疗的患者被定义为意向治疗（ITT）组。结果显示如下： 1、客观缓解率/临床受益率（ORR/CBR）：在接受至少一剂NEO-PV-01的21例患者（VAX组）中， 2例在接种疫苗后靶病灶总大小进一步缩小超30% （详见下图）。 ITT组（意向治疗组）的ORR为34%、CBR为71% （95%CI分别为19.6–51.4、54.1–84.6）； VAX组（接种疫苗的患者子集）的ORR达69%、CBR达100% （95%CI分别为41.3–89.0、79.4–100），显著优于ITT组。 ▼每位至少接种1剂疫苗（VAX组）患者的靶病变总和的最佳放射学变化（%） ▲图源“Cancer Cell”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 2、中位总生存期（OS）： ITT组患者中位OS为16.8个月（范围11.6–未达到）； VAX组中位OS延长至20个月（范围11.5–未达到）（详见下图）。 ▲图源“Cancer Cell”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 3、中位无进展生存期（PFS）： ITT组中位PFS为6.3个月（95%CI5.6–14.7个月）； VAX组中位PFS为7.2个月（范围5.7–14.7个月）（详见下图）。 ▲图源“Cancer Cell”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除小编寄语经过数十年发展，癌症疫苗已从实验室逐步走向临床研究。截至目前，美国国立卫生研究院（NIH）临床试验网站收录的在研肿瘤疫苗项目已超7000项。除前文提及的NEO-PV-01外，mRNA疫苗、树突细胞（DC）疫苗、古巴肺癌疫苗等多款肺癌治疗疫苗也在积极推进中。想了解更多详情，可阅读原文：2025年四款肺癌疫苗震撼登场！打一针治疗肿瘤的时代即将到来。参考资料 [1]Awad M M,et al.Personalized neoantigen vaccine NEO-PV-01 with chemotherapy and anti-PD-1 as first-line treatment for non-squamous non-small cell lung cancer[J]. Cancer Cell, 2022, 40(9): 1010-1026. e11. https://www.cell.com/cancer-cell/fulltext/S1535-6108(22)00359-2?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1535610822003592%3Fshowall%3Dtrue 本文为全球肿瘤医生网原创，未经授权严禁转载

临床结果疫苗临床3期

17 小时之前

·凯莱英药闻

首个！第一三共/默沙东 B7-H3 ADC 启动前列腺癌III期临床

欢迎关注凯莱英要闻7月1日，中国药物临床试验登记与信息公示平台更新了一项第一三共/默沙东登记的B7-H3 ADC药物Ifinatamab Deruxtecan相关III期临床研究，该试验为在前线转移性去势抵抗性前列腺癌（mCRPC）受试者中比较Ifinatamab Deruxtecan与多西他赛的有效性和安全性。Ifinatamab Deruxtecan也成为首个启动前列腺癌适应症III期临床的 B7-H3 ADC。该试验是一项名为 IDeate-Prostate01 的国际多中心、随机、平行、开放性的III期研究，主要终点指标为总生存期（OS）以及影像学无进展生存期（rPFS），次要终点包含TFST、OR、DOR等多项指标。目标入组患者数量为国内216人，国外1440人。Ifinatamab deruxtecan (I-DXd，DS-7300a)是一款潜在 first-in-class 靶向 B7-H3 的 ADC。该药采用第一三共独有的 DXd ADC 技术设计，由人源化抗 B7-H3 IgG1 单克隆抗体通过可裂解四肽连接子与拓扑异构酶 I 抑制剂有效载荷（一种依喜替康衍生物，DXd）连接组成。目前，Ifinatamab deruxtecan是全球研发进展最快的B7-H3 ADC，在小细胞肺癌、非小细胞肺癌、前列腺癌、食管癌、黑色素瘤等多个热门肿瘤领域均进行探索，其中小细胞肺癌、食管癌、前列腺癌均已进入临床III期试验阶段。数据来源：Insight数据库2023年10月，默沙东与第一三共宣布就三款ADC候选药物：patritumab deruxtecan（HER3-DXd）、ifinatamab deruxtecan（I-DXd）和raludotatug deruxtecan（R-DXd）达成价值220亿美元的全球（除日本外）开发和商业化协议。B7-H3B7-H3（又称CD276）是一种Ⅰ型跨膜糖蛋白，属于B7超家族中的一员，在单核细胞和粒细胞及人体正常组织中均无表达，而在一些树突状细胞、T 细胞、自然杀伤（NK）细胞和B 细胞上有表达是近年来新发现的免疫检查点。该靶点不仅可通过抑制免疫系统促成肿瘤细胞的免疫逃逸，还可通过一些非免疫途径介导肿瘤的转移、耐药、血管生成从而促进癌症进展。同属于B7家族的还有：B7-1（CD80）、B7-2（CD86）、B7-DC（PD-L2或CD273）、B7-H1（PD-L1或CD274）、B7-H2（ICOSLG）、B7-H4（VTCN1）、B7-H5（VISTA）、B7-H6（NCR3LG1）和 B7-H7（HHLA2）。B7家族被证明为T细胞激活中的共刺激或共抑制分子，其配体和受体在适应性免疫反应和恶性肿瘤中发挥关键作用。B7-H3靶点的研发可谓命途多舛，MacroGenics的B7-H3单抗曾因发生患者死亡而叫停针对头颈鳞癌的III期临床试验。如今也有接近60个项目处于非积极或不活跃状态。但这并没有阻拦各大企业对这一热门靶点的探索。现在，针对B7-H3靶点的单抗、双抗、融合蛋白、CAR-T疗法的开发都在进行中，最火热的仍属ADC。目前在研B7-H3靶点药物超过200个，ADC药物也接近70个，进入临床阶段的有20个。尚无获批上市的产品。国内企业中，翰森制药、宜联生物、映恩生物、信达生物、迈威生物、石药集团、百济神州等知名药业皆有所布局。医药交易方面，针对B7-H3靶点药物的交易达到14项，其中ADC就占11项之多。交易金额最大的属两笔国内企业与MNC巨头的授权许可。· 2023年12月，GSK与翰森制药达成全球独家授权许可协议（除大中华区外），以17.1亿美元引进翰森制药HS-20093。· 2023年4月，BioNTech与映恩生物达成独家许可合作协议，以16.7亿美元引进DB-1303（HER2）及DB-1311（B7-H3）两款药物。PD-(L)1与B7H3 ADC的双抗与联用近年来，PD-1+ADC 联合疗法在多种肿瘤一线治疗中表现十分亮眼。Ifinatamab deruxtecan作为B7-H3研发前列的领头者，在2024年4月，就启动了联合罗氏PD-L1抗体Atezolizumab，在小细胞肺癌患者中开展1/2期临床试验，计划入组总人数为149例。同样，还开展了联合帕博利珠单抗治疗一线局部晚期不可切除/转移性食管癌的I/II期临床试验。今年年初，宜联生物宣布与阿斯利康建立临床研究合作，共同探索YL201（靶向B7H3的抗体偶联药物）与度伐利尤单抗（抗PD-L1免疫检查点抑制剂）联用，治疗多种实体瘤的潜力。双方将共同启动一项多中心、开放性、I/Ib期研究，旨在评估YL201联合度伐利尤单抗在实体肿瘤患者中的安全性、有效性和药代动力学。翰森制药也在2025年正式启动HS-20093和PD-L1抗体Adebrelimab、EGFR抗体Cetuximab、前列腺去势药物恩杂鲁胺(Enzalutamide)等多种药物治疗实体瘤的I期试验。映恩生物与BioNTech达成交易的DB-1311也在2025年登记新的Ib/II期临床研究，联合PDL1/VEGF双抗BNT327用于治疗晚期肺癌。而映恩生物自身的DB-1419作为B7-H3/PD-L1双抗ADC也于陆续在国内外获批临床，用于治疗晚期/转移性实体瘤。感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“queenachuen”。“在看”点一下

抗体药物偶联物临床3期临床成功临床结果临床2期

22 小时之前

·Firstwordpharma

BMS-backed bispecific notches Phase III win in nasopharyngeal cancer

Bristol Myers Squibb's $8.4-billion wager on Chinese developed antibody-drug conjugates (ADCs) is showing early signs of paying off, with partner Sichuan Biokin Pharmaceutical reporting that its experimental therapy izalontamab brengitecan (iza-bren; BL-B01D1) succeeded in a Phase III trial for advanced nasopharyngeal carcinoma. The results, disclosed in a regulatory filing Wednesday, represent the first major clinical win for the first-in-class ADC, which targets both EGFR and HER3 proteins.The study, dubbed BL-B01D1-303, enrolled 386 patients with recurrent or metastatic disease who had failed at least two lines of platinum-based chemotherapy after receiving PD-1/PD-L1 monoclonal antibody as the last line of therapy. The interim findings come roughly 18 months after the study's start in late 2023.BMS secured ex-China rights to iza-bren in December 2023 with an $800-million upfront payment to Biokin's US arm, SystImmune. The deal could be worth up to $8.4 billion if the drug hits key milestones – including $500 million tied to near-term clinical progress. More details about the transaction were disclosed in a Hong Kong Stock Exchange filing earlier this year. Specifically, BMS owes $250 million if a Phase II or III trial starts in first- or second-line patients in the US by the end of 2025, and another $250 million if a first-line Phase III trial begins by the end of 2026.Biokin says iza-bren is being tested in over 40 studies across different tumour types, mostly in China, but also in the US.BMS began a Phase I/IIa trial of iza-bren in combination with AstraZeneca's Tagrisso (osimertinib) or Merck & Co.'s Keytruda (pembrolizumab) in the US last December for advanced solid tumours. BMS is also slated to initiate the Phase II/III IZABRIGHT-Breast01 comparing iza-bren and chemotherapy in first-line metastatic triple-negative breast cancer or oestrogen receptor-low/HER2-negative breast cancer patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies, with primary completion expected in early 2028.

临床3期抗体药物偶联物引进/卖出临床结果

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外链

KEGG	Wiki	ATC	Drug Bank
D10574	帕博利珠单抗	L01XC18	DB09037

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
不可切除的肝细胞癌	中国	Merck Sharp & Dohme LLC	2025-06-10
恶性胸膜间皮瘤	美国	Merck & Co., Inc.	2024-09-17
恶性胸膜间皮瘤	美国	Merck Sharp & Dohme LLC	2024-09-17
不可切除的尿路上皮癌	欧盟	Merck Sharp & Dohme BV	2024-07-25
不可切除的尿路上皮癌	冰岛	Merck Sharp & Dohme BV	2024-07-25
不可切除的尿路上皮癌	列支敦士登	Merck Sharp & Dohme BV	2024-07-25
不可切除的尿路上皮癌	挪威	Merck Sharp & Dohme BV	2024-07-25
晚期子宫内膜癌	美国	Merck Sharp & Dohme LLC	2024-06-17
MSI-H 子宫内膜癌	美国	Merck Sharp & Dohme LLC	2024-06-17
错配修复缺陷子宫内膜癌	美国	Merck Sharp & Dohme LLC	2024-06-17
晚期胃癌	日本	MSD KK	2024-05-17
复发性胃癌	日本	MSD KK	2024-05-17
不能切除的胆道癌	加拿大	Merck Sharp & Dohme Corp.	2024-05-09
晚期胆道癌	中国	Merck Sharp & Dohme LLC	2024-01-30
局部晚期胆管癌	中国	Merck Sharp & Dohme LLC	2024-01-30
胃腺癌	挪威	Merck Sharp & Dohme BV	2023-12-20
HER2阴性胃癌	美国	Merck Sharp & Dohme LLC	2023-11-16
可切除非小细胞肺癌	美国	Merck Sharp & Dohme Corp.	2023-10-16
HER2阳性胃腺癌	欧盟	Merck Sharp & Dohme BV	2023-09-06
HER2阳性胃腺癌	冰岛	Merck Sharp & Dohme BV	2023-09-06

未上市

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期头颈部鳞状细胞癌	申请上市	美国	Merck Sharp & Dohme LLC	2025-02-25
小肠癌	申请上市	欧盟	Merck Sharp & Dohme Corp.	2022-03-25
胶质母细胞瘤	临床3期	美国	Merck Sharp & Dohme LLC	2025-02-03
胶质母细胞瘤	临床3期	美国	NovoCure GmbH	2025-02-03
胶质母细胞瘤	临床3期	法国	NovoCure GmbH	2025-02-03
胶质母细胞瘤	临床3期	以色列	NovoCure GmbH	2025-02-03
胶质母细胞瘤	临床3期	以色列	Merck Sharp & Dohme LLC	2025-02-03
胶质母细胞瘤	临床3期	英国	Merck Sharp & Dohme LLC	2025-02-03
多形性胶质母细胞瘤	临床3期	美国	Merck Sharp & Dohme LLC	2025-02-03
多形性胶质母细胞瘤	临床3期	法国	Merck Sharp & Dohme LLC	2025-02-03

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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


NCT05634577 (CTgov)	临床2期	肾上腺皮质癌	3	Pembrolizumab+Mitotane	鹽餘鑰構製窪鑰願餘廠(繭蓋糧繭蓋築窪築鑰鹹) = 鬱構獵築選餘積鹹鏇淵鹽鹹襯膚鏇鬱夢鏇鹹觸 (鹽廠鹽築簾築鹹選餘憲, 鏇壓鹹膚繭襯夢鬱繭蓋 ~ 觸壓窪獵襯襯蓋餘網鹹) 更多	-	2025-06-19
NCT03867175 (CTgov)	临床3期	继发性肺恶性肿瘤 \| 转移性非小细胞肺癌	5	Stereotactic Body Radiation Therapy+Pembrolizumab (Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab)	蓋鹹淵構鬱顧憲簾廠壓 = 襯艱壓鹽繭鏇鹹蓋鏇願壓淵壓積獵築鑰糧鹽憲 (膚餘壓艱膚膚壓遞繭蓋, 餘網淵憲鹽製鏇夢選顧 ~ 簾窪積積積鬱積獵簾夢) 更多	-	2025-06-13
				Pembrolizumab (Arm 2 Pembrolizumab Only)	蓋鹹淵構鬱顧憲簾廠壓 = 積廠糧糧鹹蓋獵廠構糧壓淵壓積獵築鑰糧鹽憲 (膚餘壓艱膚膚壓遞繭蓋, 蓋醖鹽鑰艱鑰範衊糧膚 ~ 鹹構積積觸遞鹹壓衊襯) 更多
KEYNOTE-189 and KEYNOTE-407 (Pubmed \| Oncol Ther)	N/A	非小细胞肺癌一线	1,175	Pembrolizumab plus Chemotherapy	襯積鑰構衊顧鑰顧夢構(夢艱齋醖製鑰鹽鏇鬱鬱) = 遞範醖簾觸醖衊繭艱憲齋鏇鑰廠願艱醖鬱淵衊 (夢艱窪廠壓壓顧淵醖憲 )	积极	2025-06-11
NCT02899793 (CTgov)	临床2期	复发性子宫内膜癌	25	Pembrolizumab	鹹淵廠醖製積鏇鹽範壓 = 繭鹹鬱網構構壓鏇蓋窪願夢築鏇網簾膚膚窪壓 (獵範齋築遞築膚選膚網, 夢築遞鹹膚獵憲網鬱窪 ~ 鏇壓壓鹹鹹窪築襯簾築) 更多	-	2025-06-11
NCT03582475 (phase 1b study, CTgov)	临床1期	膀胱尿路上皮癌 \| 转移性尿道尿路上皮癌 \| 去势抵抗性前列腺癌 ... 更多	15	etoposide+Carboplatin+Docetaxel+Cisplatin+Pembrolizumab (Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer)	鑰醖繭憲願顧範遞餘壓 = 鹽選遞鏇製獵膚艱遞鑰製積艱齋願衊獵鹹遞夢 (鹹醖顧艱窪鏇膚願鹽蓋, 艱窪網積窪醖齋積簾選 ~ 淵遞鬱獵觸製衊衊繭夢) 更多	-	2025-06-10
				etoposide+carboplatin+docetaxel+pembrolizumab (Cohort 2: Small Cell or Neuroendocrine Prostate Cancer)	鑰醖繭憲願顧範遞餘壓 = 築遞齋獵簾獵獵糧網齋製積艱齋願衊獵鹹遞夢 (鹹醖顧艱窪鏇膚願鹽蓋, 鏇簾網遞顧願範壓衊鹹 ~ 鬱衊餘蓋襯範積鹽襯糧) 更多
NCT04251169 (Solti-1716 TATEN \| TATEN, CTgov)	临床2期	转移性乳腺癌 \| 晚期乳腺癌 \| HR阳性/HER2阴性乳腺癌	20	Paclitaxel+Pembrolizumab	襯鹹膚壓膚餘蓋壓鑰鬱(糧網醖簾艱築窪鹹遞鹹) = 鹹餘衊獵憲網獵壓憲獵衊糧齋鑰築鹽憲製製糧 (糧願廠衊衊選範鹹艱選, 觸餘鹽鑰網膚築醖襯範 ~ 選鏇襯襯鏇觸範選鹽膚) 更多	-	2025-06-03
NCT02787005 (KEYNOTE-199, Pubmed \| Prostate Cancer Prostatic Dis) 人工标引	临床2期	转移性去势抵抗性前列腺癌	126	Pembrolizumab 200 mg	鏇襯鹹鑰襯憲獵獵窪壓(構鬱鹽觸鑰鏇選廠齋築) = 製鹹鏇鬱製鏇簾窪衊糧製顧艱鏇淵積鹹餘簾壓 (淵觸蓋淵遞壓選鏇蓋觸, 6.1 ~ 21.5) 更多	积极	2025-06-01
				Pembrolizumab	鹽襯窪齋簾鏇襯鹹壓餘(窪築糧繭壓齋鹹膚遞餘) = 鹽遞鹽範鬱齋積衊簾鏇製顧積繭憲願繭繭廠簾 (繭獵衊憲廠鬱夢鏇顧齋, 35.8 ~ 66.3) 更多
Pubmed \| Eur Urol Oncol	N/A	转移性去势抵抗性前列腺癌	-	Pembrolizumab	淵糧獵鹽窪淵鏇憲蓋遞(壓窪積憲廠獵遞觸齋鹹) = 廠製膚鏇獵鹹窪鹹範夢醖餘艱艱願醖蓋夢膚鏇 (鑰醖襯蓋觸鹹製製網鹹 ) 更多	-	2025-06-01
NCT02899793 (Pubmed \| Gynecol Oncol)	临床2期	复发性子宫内膜癌 MSI-H \| dMMR \| Lynch-like ... 更多	-	pembrolizumab (Lynch-like subgroup)	獵餘鑰築膚襯選鹹鬱鹽(淵製獵願蓋繭積憲襯壓) = 糧顧鏇範蓋壓簾獵觸襯窪鑰廠膚築選製願鹽餘 (窪襯膚遞網繭齋膚夢觸 ) 更多	积极	2025-06-01
				pembrolizumab (Methylated subgroup)	獵餘鑰築膚襯選鹹鬱鹽(淵製獵願蓋繭積憲襯壓) = 淵獵鑰衊製夢糧衊窪夢窪鑰廠膚築選製願鹽餘 (窪襯膚遞網繭齋膚夢觸 ) 更多
NCT04849364 (PERSEVERE, CTgov)	临床2期	三阴性乳腺癌	52	pembrolizumab+inavolisib+capecitabine (Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway)	範膚顧簾鑰鑰鏇構膚簾 = 顧鏇膚齋願艱選衊顧鹹範艱糧窪鏇製網膚獵鏇 (壓窪衊窪願憲艱網夢鏇, 壓遞鑰願鹹壓製夢鏇壓 ~ 糧廠製廠廠範鑰觸淵夢) 更多	-	2025-05-31
				Pembrolizumab+Capecitabine (Arm 2: ctDNA Positive - Standard of Care)	艱蓋衊淵鹹繭選壓憲蓋 = 鹹網製淵選鹽築蓋顧積鑰鏇醖餘鹽選積夢窪鹹 (夢廠鹽廠壓選構選顧憲, 蓋衊蓋壓壓糧壓遞廠簾 ~ 積願鹹淵襯廠鹹顧夢窪) 更多