This is a single center, open-label phase I clinical trial designed to determine the safety of personalized and adjusted neoantigen peptide vaccine (PANDA-VAC) administered concurrently with pembrolizumab in subjects with advanced squamous non-small cell lung cancer (NSCLC) or squamous cell carcinoma of head and neck (SCCHN).

开始日期2027-05-20

申办/合作机构

Lineberger Comprehensive Cancer Center

NCT07603856

/ Not yet recruiting临床2期IIT

A Randomized Phase II Study of Radiotherapy Plus Immune Checkpoint Inhibitor Therapy Versus Standard of Care Chemotherapy in Patients With Metastatic or Relapsed Non-Small Cell Lung Cancer Previously Treated With Immunotherapy

Current clinical trials testing the combination of immunotherapy with radiotherapy.

开始日期2026-12-12

申办/合作机构

The University of Chicago

NCT07572123

/ Not yet recruiting临床2/3期IIT

A Two Cohort Randomized Study for Patients With High Risk (Phase II) and Standard Risk (Phase III) Classical Hodgkin Lymphoma in First Relapse

This phase II trial compares the impact of brentuximab vedotin and nivolumab after radiation to standard of care high dose chemotherapy (HDT)-autologous stem cell transplant (ASCT) in standard-risk patients with classic Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). In addition, the phase III trial will compare the effect of pembrolizumab after HDT-ASCT to standard of care HDT-ASCT alone in high-risk patients with relapsed or refractory classic Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. An ASCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving HDT before an ASCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Radiation therapy (RT) uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving brentuximab vedotin and nivolumab after radiation may be safe, tolerable and more effective than standard of care HDT-ASCT in treating patients with standard risk relapsed or refractory classic Hodgkin lymphoma. In addition, giving pembrolizumab after standard of care HDT-ASCT may be safe and tolerable and more effective than HDT-ASCT alone in treating high-risk patients with relapsed or refractory classic Hodgkin lymphoma.

开始日期2026-12-04

申办/合作机构

National Cancer Institute

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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9,843

项与帕博利珠单抗相关的文献（医药）

2026-12-31·INTERNATIONAL JOURNAL OF HYPERTHERMIA

Focused ultrasound ablation surgery combined with immune checkpoint inhibition in driver-gene wild-type NSCLC with liver metastasis: a feasibility study

Article

作者: Wang, Ting ; Chen, Jinyun ; Ouyang, Bing ; Chen, Li ; Chen, Wenzhi

BACKGROUND:

This single-arm, open-label clinical trial aimed to evaluate the preliminary safety, efficacy and feasibility of focused ultrasound ablation surgery (FUAS) sequential with immune checkpoint inhibitors (ICIs) in patients with driver-gene wild-type non-small cell lung cancer (NSCLC) and liver metastases.

MATERIALS AND METHODS:

Ten eligible patients received two cycles of FUAS sequential with ICIs. The ICIs used include Camrelizumab (7/10), Pembrolizumab (3/10) and Serplulimab used for immune rechallenge (1/10). Follow-up was conducted every 6 weeks ± 3 days, including imaging and hematological assessments. Treatment-related adverse events (AEs) were documented anytime.

RESULTS:

All participants demonstrated stable tolerability and safety in this trial. Immediate post-FUAS ablation rates ranged from 73% to 80%. The median follow-up time is 84 days (IQR, 42-127 days). From baseline to week 18, continuous shrinkage of both hepatic metastatic and target lesions was observed. The DCR of the tumor has reached 80% since the 2nd follow-up (12 weeks), and it remains at 50% until the 4th follow-up (24 weeks).

CONCLUSION:

FUAS sequential with ICIs suggests preliminary safety, activity and feasibility in treating driver-gene wild-type NSCLC patients with liver metastases, further validation is needed.

2026-12-31·Human Vaccines & Immunotherapeutics

Mapping research trends in esophageal cancer immunotherapy: A decade of thematic evolution and emerging priorities

Review

作者: Zang, Qiwei ; Jia, Huijun ; Wei, Hongyu ; Gong, Yifan ; Zhao, Chengguang

Immunotherapy has become a pivotal therapy for various cancers, including esophageal cancer, showing promising potential in improving survival rates and enabling personalized care. However, significant challenges occur in identifying predictive biomarkers, refining combination therapies, and managing immunotherapy-related adverse effects. This bibliometric study analyzed publications related to the use of immunotherapy in esophageal cancer management over a 10-y period (January 1, 2015, to October 14, 2024), retrieved from the Web of Science Core Collection. Keyword co-occurrence and co-citation analyses were performed to identify key contributors, central themes, and influential publications. A total of 545 publications on esophageal cancer immunotherapy were included in the analysis. A sharp increase in publication volume was observed beginning in 2019, with a peak between 2021 and 2023. China emerged as the leading contributor, accounting for 67.7% of the total output, while Zhengzhou University produced the highest number of publications among all institutions. Prominent individual contributors included Ken Kato and Shen Lin. Research hotspots centered on PD-1/PD-L1 inhibitors, combination therapies, and tumor microenvironment modulation. Notably, a clear temporal evolution in research focus was observed, with early studies emphasizing specific immune checkpoint targets and agents (e.g., PD-1, Pembrolizumab, and CTLA-4), followed by a shift toward mechanistic investigations involving the tumor microenvironment, treatment resistance, and prognosis. This study provides a comprehensive view of immunotherapy in the management of esophageal cancer, offering direction for future research and valuable insights for clinical innovation.

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Economic evaluation of perioperative pembrolizumab plus standard of care as treatment for resectable locally advanced head and neck squamous cell carcinoma in the United States

Article

作者: Chafamo, Biruk ; Fernan, Catherine ; Muston, Dominic ; Qian, Feng ; Johnson, Geoffrey ; Tang, Yuexin ; Bensimon, Arielle G. ; Adkins, Douglas ; Zheng, Dandan ; Benjamin, Kimberly ; Tzontcheva, Anjela ; Uppaluri, Ravindra

AIMS:

In the phase 3 KEYNOTE-689 trial (NCT03765918) among patients with resectable locally advanced head and neck squamous cell carcinoma (LA HNSCC), perioperative pembrolizumab (pembrolizumab before surgery, then continued with standard-of-care [SOC] radiotherapy +/- cisplatin after surgery followed by pembrolizumab alone) significantly prolonged event-free survival vs. SOC alone, both in the intention-to-treat population and PD-L1 combined positive score (CPS) ≥1 subgroup. Perioperative pembrolizumab + SOC received Food and Drug Administration approval in June 2025 for resectable LA HNSCC expressing PD-L1 (CPS ≥ 1). The present study evaluated the cost-effectiveness of perioperative pembrolizumab + SOC versus SOC in this indication, from a US healthcare payer perspective.

MATERIALS AND METHODS:

A Markov cohort model with four states (event-free, local recurrence, incurable recurrence/progression, death) was developed to estimate lifetime costs, life years (LYs), and quality-adjusted LYs (QALYs) with 3% annual discounting. Transition probabilities were fitted to patient-level time-to-event data from KEYNOTE-689 through parametric multistate modelling. Costs of initial and subsequent treatment, adverse events, disease management, and terminal care were estimated in 2025$ based on trial results, drug labels, public databases, and literature. Utilities were derived through analyses of EQ-5D-5L data collected in KEYNOTE-689. Deterministic and probabilistic sensitivity analyses were performed.

RESULTS:

Compared to SOC, perioperative pembrolizumab + SOC increased total costs by $82,311 and provided gains of 1.47 QALYs and 1.77 LYs. Incremental cost-effectiveness ratios of perioperative pembrolizumab + SOC vs. SOC were $55,863/QALY and $46,406/LY. Higher initial treatment costs of perioperative pembrolizumab (incurred mainly in Year 1) were partially offset by lower recurrence-related costs. At the typical $150,000/QALY threshold, perioperative pembrolizumab + SOC was cost-effective in 96% of probabilistic simulations.

LIMITATIONS:

Survival extrapolations beyond the available trial period are subject to uncertainty.

CONCLUSIONS:

Perioperative pembrolizumab + SOC was found to be cost-effective versus SOC for the treatment of resectable LA HNSCC with CPS ≥ 1.

13,566

项与帕博利珠单抗相关的新闻（医药）

2026-05-26

·PRNewswire

John Theurer Cancer Center at Hackensack University Medical Center Presents Innovative Cancer Research at Major Annual Cancer Meeting

HACKENSACK, N.J., May 26, 2026 /PRNewswire/ -- Investigators from Hackensack Meridian John Theurer Cancer Center (JTCC)—part of the National Cancer Institute-designated Lombardi Comprehensive Cancer Center at Georgetown University—and Hackensack University Medical Center are reporting research findings at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting is the premier event for cancer professionals and takes place in Chicago from May 29 to June 2. Continue Reading John Theurer Cancer Center at Hackensack University Medical Center to present at American Society of Clinical Oncology (ASCO) Annual Meeting. John Theurer Cancer Center at Hackensack Meridian Hackensack University Medical Center, Part of Georgetown Lombardi Comprehensive Cancer Center "The future of cancer treatment begins with translating today's pioneering exploration into tomorrow's standard of care, a theme that resonates strongly at this year's ASCO meeting. For patients who do not respond to standard treatments, it is critical that they have access to a world-class research program. At the John Theurer Cancer Center, our globally recognized investigators are committed to this translation, driving the latest advances in cellular therapy, immunotherapy, and other innovative areas to improve outcomes for patients across the Hackensack Meridian Health network and beyond," said Dr. Andre Goy, chair, vice president, physician-in-chief of oncology, at Hackensack Meridian John Theurer Cancer Center. Many of the studies focus on innovative therapies for blood cancers and novel immunotherapies. These are areas of expertise for John Theurer Cancer Center, New Jersey's largest cancer center. The findings of these investigations have the potential to change the treatment and understanding of hematologic, solid tumors, melanoma and other cancers. ASCO posters/presentations/publications that include authors from John Theurer Cancer Center: Solid Tumors Dominant chromosomal abnormalities in breast cancer metastasis to CNS as compared with systemic metastasis demonstrated by liquid biopsy. Hypercalcemia as a marker of in-hospital mortality and resource utilization in breast cancer: A national analysis. Baseline biomarker analysis and clinical outcomes of the PD-1/TGFβR2 bispecific antibody INCA33890 in patients with non-MSI-H metastatic colorectal cancer (mCRC). Phase 1 study of LB1908, an autologous claudin 18.2-targeted CAR-T cell product, in subjects with advanced gastroesophageal adenocarcinoma. Phase I, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug conjugate (ADC) in patients with advanced solid tumors. BXCL701 plus pembrolizumab in second-line advanced pancreatic ductal adenocarcinoma: Final outcomes of the EXPEL PANC trial. A phase 1, first-in-human, multicenter study of ZW251, a novel glypican-3 (GPC3)–targeted antibody-drug conjugate (ADC), in participants with hepatocellular carcinoma (HCC). Real-world outcomes of amivantamab monotherapy in advanced EGFR-mutant non-small cell lung cancer. Real-world efficacy and safety of tarlatamab in small cell lung cancer (SCLC) and extrapulmonary small cell carcinoma (EPSCC): A single-center experience. Phase Ib results from the phase Ib/II study of [177Lu]Lu-DOTA-TATE in combination with standard of care as a first-line treatment for pts with extensive-stage small cell lung cancer. Final analysis of the biomarker-directed, randomized, phase 2 KEYNOTE-495/KeyImPaCT study of pembrolizumab (P)–based combination therapy for non–small cell lung cancer (NSCLC). Hematologic Malignancies Efficacy and hematopoietic recovery of high-dose melphalan with stem cell rescue as bridging to CAR-T compared with non-intensive bridging in relapsed/refractory multiple myeloma. Distinction of FLT3-ITD transcriptomic signature from FLT3-TKD and the frequency of this signature in acute myeloid leukemia without FLT3 mutation. Defining APOBEC-like signature in diffuse large B-cell lymphoma and demonstration of distinct transcriptomic profile. KITE-753: A phase 2 study of an autologous anti-CD19/CD20 CAR T-cell therapy in CAR-naive patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Outcomes of lisocabtagene maraleucel (liso-cel) in patients (pt) with relapsed or refractory (R/R) mantle cell lymphoma (MCL): First real-world data from the CIBMTR. Carfilzomib-based combinations for Waldenström macroglobulinemia: Real-world experience from a single center. MACROD2 and CDKN2A in multiple myeloma: Insights to germline susceptibility and cytogenetic risk from long-read Nanopore sequencing. Real-world outcomes and subsequent treatment utilization following anti-B-cell maturation antigen antibody-drug conjugate exposure in patients with multiple myeloma. Immunotherapy ASP2998, a trophoblast cell-surface antigen 2 (TROP2)–targeted immunostimulatory antibody-drug conjugate with dual payloads, in patients with locally advanced unresectable or metastatic solid tumors: A phase 1b/2 study. A phase 1 study of BGB-A3055 (anti-CCR8) with or without tislelizumab (anti–PD-1) in patients with solid tumors. Melanoma Individualized neoantigen therapy intismeran autogene (intismeran) plus pembrolizumab (pembro) in resected melanoma: 5-year update of the KEYNOTE-942 study. Models of Care Are socio-economic status indicators barriers for enrollment in phase 1 clinical trials? Enrollment outcomes after screening in phase 1 oncology clinical trials: Real-world evidence from a NCI-designated cancer center. Rethinking risk: Disparities and genetic testing outcomes from a novel public-facing cancer prevention program. Risk stratification in systemic AL amyloidosis with cardiac involvement using a multiparametric echocardiography score. SOURCE Hackensack Meridian John Theurer Cancer Center 21% more press release views with Request a Demo

2026-05-26

·ioncology

ESMO BC国际视野丨Neelima Vidula教授：帕博利珠单抗联合卡铂未能改善伴胸壁疾病晚期乳腺癌的疾病控制，但持久缓解的探索仍在继续

编者按：2026年ESMO BC年会上，来自麻省总医院的Neelima Vidula教授报告了一项颇具临床启示意义的随机II期研究——ICI-CHEST, TBCRC044（摘要号：425RO）。该研究直面临床棘手难题，探索了在预后极差、对全身治疗反应不佳的伴胸壁疾病晚期乳腺癌（CWD ABC）中，于标准化疗卡铂基础上联合PD-1抑制剂帕博利珠单抗能否带来获益。结果显示，两组18周疾病控制率（20% vs. 17%）和无进展生存期均无显著差异，这提示CWD可能属于免疫“冷”肿瘤，单纯联合免疫检查点抑制剂难以克服其治疗耐药。肿瘤瞭望特邀Neelima Vidula教授深入解读该研究数据，并分享从这项迄今最大规模的CWD全身治疗试验中获得的临床洞见与未来转化研究布局。 ESMO BC 研究简介研究背景伴胸壁病变（CWD）的晚期乳腺癌（ABC）对全身治疗反应欠佳。部分三阴性乳腺癌（TNBC）对免疫检查点抑制剂（ICIs）有应答。我们研究了帕博利珠单抗（一种ICI）联合卡铂在难治性CWD患者中的疗效。研究方法我们在7家转化乳腺癌研究联盟（TBCRC）中心开展了一项针对不可切除CWD患者的随机II期试验。入组标准为患有TNBC、HR+/HER2-（既往接受过≥2线内分泌治疗）及HER2+（标准治疗后）CWD的患者，并按2∶1随机分配至A组：帕博利珠单抗200 mg +卡铂AUC 5（每3周一次）和B组：卡铂 AUC 5（每3周一次）；HER2+ CWD患者加用曲妥珠单抗。A组治疗至少6个周期；达到完全缓解（CR）/部分缓解（PR）/疾病稳定（SD）的患者可停用卡铂并继续帕博利珠单抗治疗（Arm Ax）。B组患者在出现疾病进展（PD）后可交叉至帕博利珠单抗±卡铂治疗组（Arm Bx）。主要终点是18周疾病控制率（DCR，达到CR/PR/SD的患者所占的百分比）[研究基于A组与B组间20%的DCR差异进行统计学效能计算]。研究结果共随机入组76例患者（A组：52例，B组：24例）。两组基线特征均衡，但A组既往铂类药物使用比例更高、非胸壁远处转移更多见，而B组既往ICI使用比例更高。 A组与B组的18周DCR（20% vs 17%）、无进展生存期（9% vs 10%）、客观缓解率（10% vs 21%）以及胸壁最佳缓解情况（55% vs 50%）均相似。 A组中14例（27%）患者（范围6-24周期）和B组中7例（29%）患者（范围6-18周期）接受了＞6个周期的治疗。B组有16例患者交叉至Bx组，中位治疗持续2.5个周期（范围1-8周期），其中4例（25%）患者疾病稳定（SD）持续＞9周。研究结论在CWD患者中，帕博利珠单抗+卡铂组的18周DCR与卡铂组相似，提示CWD属于免疫“冷”肿瘤，需要新的策略来激发免疫应答。目前正在分析试验患者的CWD活检，以确定与其他CWD相比，持久缓解的是PD-L1阳性的CWD或免疫浸润的CWD。这是CWD中规模最大的全身性治疗试验，明确了化疗在CWD中的缓解情况，可作为未来研究的基准。 ESMO BC 研究者说 Neelima Vidula 教授麻省总医院我叫Neelima Vidula是麻省总医院乳腺肿瘤内科医生、哈佛医学院医学助理教授。同时，我也是麻省总医院乳腺癌伴胸壁疾病综合项目的主任，以及乳腺项目临床试验委员会主任和临床研究副主任。今天，我很荣幸能在2026年ESMO乳腺癌（ESMO BC）年会上发言，并向大家展示题为“A randomized phase II study of pembrolizumab plus carboplatin vs. carboplatin alone in unresectable advanced breast cancer (ABC) with chest wall disease (CWD) [ICI-CHEST, TBCRC 44]”的研究成果。晚期乳腺癌伴胸壁疾病可能影响10%至15%的乳腺癌患者，可表现为炎性乳腺癌、淋巴管炎性乳腺癌，并出现皮肤结节和溃疡。这类疾病患者对全身治疗的反应较差，且具有高发病率和较差的总生存期。我们知道部分乳腺癌可能对免疫治疗产生应答。因此，我们开展了一项由研究者发起的多中心随机II期临床试验，纳入了所有亚型、胸壁不可切除且疾病进展的乳腺癌患者。在这项研究中，我们将患者按2:1随机分配，一组（A组）接受帕博利珠单抗联合卡铂治疗至少6个周期，之后若疾病缓解，可选择继续帕博利珠单抗联合或不联合卡铂治疗；另一组（B组）先接受卡铂单药治疗，若疾病进展，可选择交叉加用帕博利珠单抗联合或不联合卡铂。对于HER2阳性乳腺癌患者，我们还加用了曲妥珠单抗。本研究的主要终点是治疗18周的疾病控制率。AB两组中大部分患者为三阴性乳腺癌，既往接受过胸壁和乳腺放疗，且接受过多线全身治疗。但值得注意的是，接受卡铂联合帕博利珠单抗组的患者基线时远处转移比例更高。我们最终发现，主要终点18周疾病控制率在两组间相似，帕博利珠单抗联合卡铂治疗组为20%，卡铂单药组为17%。此外，中位无进展生存期在两组间也相似，博利珠单抗联合卡铂治疗组为9周，单药组为10周。在持久缓解方面（定义为接受了＞6个周期治疗的患者），联合治疗组中有27%的患者达到了持久缓解，而单药组则为29%。另外，16例初始接受卡铂单药的患者在疾病进展后交叉至帕博利珠单抗联合或不联合卡铂治疗，中位治疗持续2.5个周期，其中4例患者疾病稳定超过9周。我们的研究表明，胸壁疾病患者接受帕博利珠单抗联合卡铂与单用卡铂的18周疾病控制率相似。然而，在卡铂单药组和联合组中分别有29%和27%的患者观察到持久缓解。下一步，我们正在开展大量相关性研究工作，通过分析胸壁活检标本中的PD-L1表达和免疫浸润情况，来了解该情境下免疫治疗对化疗的贡献。我们同时也在研究游离DNA（cfDNA）、肿瘤组织活检的PD-L1表达以及循环肿瘤细胞，以阐明它们如何与疗效产生关联。总体而言，本研究是迄今为止针对胸壁疾病开展的最大规模的临床试验，它确定了这一患有严重疾病的群体对基线化疗的反应率。 Neelima Vidula 麻省总医院血液肿瘤与医学肿瘤科麻省总医院乳腺肿瘤内科医生哈佛医学院医学助理教授麻省总医院乳腺癌伴胸壁疾病综合项目主任、乳腺癌项目临床试验委员会主任和临床研究副主任（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

2026-05-26

·ioncology

首个且唯一！芦康沙妥珠单抗首个妇瘤III期试验传捷报，TroFuse-005研究喜提PFS和OS双阳终点

点击上方蓝字关注我们编者按：2026年5月18日，默沙东（Merck，称MSD）宣布，其与科伦博泰合作研发的TROP2抗体偶联药物（ADC）芦康沙妥珠单抗（Sac-TMT）在针对晚期或复发性子宫内膜癌的全球III期TroFuse-005研究中，同时达到了总生存期（OS）和无进展生存期（PFS）的双重主要终点[1]。这是全球首个且唯一一个在该治疗背景下，相比化疗显著改善OS和PFS的TROP2 ADC，标志着子宫内膜癌治疗领域迎来了里程碑式的突破。未尽之需：晚期子宫内膜癌治疗面临严峻挑战子宫内膜癌又称子宫体癌，是全球女性常见的恶性肿瘤之一，根据GLOBOCAN 2022数据，每年全球新发子宫内膜癌约42万例（居女性恶性肿瘤第6位），死亡近10万例[2]。国家癌症中心的最新数据则显示，2024年我国新发子宫内膜癌7.56万例（位居女性恶性肿瘤第8位），死亡1.25万例[3]，且我国的子宫内膜癌发病率仍呈上升趋势，疾病负担可能继续加重[4]。化疗仍是复发或转移性子宫内膜癌系统治疗的主要选择。尽管近年来免疫治疗联合化疗在晚期一线治疗中取得了一定进展，但对于一线含铂化疗及抗PD-1/L1免疫治疗（序贯或联合）后仍出现疾病进展的晚期或复发性子宫内膜癌患者，治疗选择极为有限[5]。既往二线及后线治疗主要依赖多柔比星或紫杉醇等单药化疗，客观缓解率（ORR）不足15%，中位PFS仅3～4个月，中位OS不足12个月[6]。机制创新：芦康沙妥珠单抗的差异化ADC设计芦康沙妥珠单抗（Sac-TMT）是我国科伦博泰自主研发、默沙东全球合作开发的一款新型TROP2 ADC，其药物机制具有多项独有或领先特征：抗体端不可逆偶联技术：显著提高了ADC在血液循环中的稳定性，减少payload提前释放，降低脱靶毒性。新型拓扑异构酶I抑制剂T30：具备高效抗肿瘤活性，且不易与常用化疗产生交叉耐药。高药物抗体比（DAR 7.4）：每个抗体携带约7.4个毒素分子，高于同靶点其他ADC，提升肿瘤杀伤效能。抗肿瘤旁观者效应：可穿透细胞膜杀伤邻近肿瘤细胞，对TROP2异质性表达的肿瘤同样有效。这些机制优势使芦康沙妥珠单抗在早期临床中即展现出优于传统化疗和部分同类ADC的疗效与可控的安全性。早期探索：从I/II期研究看妇科肿瘤领域潜力目前，已有多项I/II期期研究显示芦康沙妥珠单抗在宫颈癌、子宫内膜癌和卵巢癌晚期治疗中显示出积极的抗肿瘤活性。这些数据为后续III期研究奠定了坚实基础。 2025年ESMO大会报道的II期研究子宫内膜癌扩展队列，纳入了158例接受过≥1线铂类化疗进展的晚期子宫内膜癌患者，结果显示：客观缓解率（ORR）为35.4%（确认ORR: 31.6%），疾病控制率（DCR）为74.7%，中位持续缓解时间（DOR）为9.3个月。其中，4 mg/kg组的ORR为35.1%、中位PFS和OS分别为6.0个月和14.4个月；5 mg/kg组的ORR达36.4%，中位PFS 和OS分别达7.3个月和18.1个月，未发现新的安全性事件，芦康沙妥珠单抗的安全性可控[9]。在近期举行的2026年SGO大会上则报道了芦康沙妥珠单抗联合免疫治疗的II期MK-2870-002/SKB264-II-06研究[10-11]也显示积极结果：（1）针对BRCA野生型、铂敏感复发性卵巢癌患者（n=40），使用芦康沙妥珠单抗联合帕博利珠单抗作为二线维持治疗，获得20.9个月的中位PFS，中位OS尚未达到，1年OS率高达92%。（2）针对既往接受过1-2线治疗的复发或转移性宫颈癌患者，接受芦康沙妥珠单抗3mg/kg、4mg/kg及5mg/kg Q2W联合帕博利珠单抗治疗，ORR达51%（免疫经治亚组ORR达54%），中位PFS和OS分别达7.3个月和18.9个月，联合治疗的安全性和耐受性同样表现良好。里程碑式突破：TroFuse-005研究达OS与PFS双重主要终点 2026年5月18日，默沙东正式宣布TroFuse-005（NCT06132958）研究达到预设主要终点。这是全球首个在晚期或复发性子宫内膜癌患者中，对比医生选择的化疗方案（TPC：多柔比星或紫杉醇）实现OS和PFS双重显著获益的TROP2 ADC III期研究，同时达到ORR关键次要终点[1]。这是一项随机、开放标签、多中心、全球III期试验[12]，共入组776例患者。入组标准为：既往接受过至少一线含铂化疗及抗PD-1/L1免疫治疗后进展的晚期或复发性子宫内膜癌或癌肉瘤患者，随机分配至芦康沙妥珠单抗组（4mg/kg，Q2W）或医生选择的化疗组（多柔比星60mg/m²，Q3W或紫杉醇80mg/m²）。主要终点为BICR评估的PFS及OS。关键次要终点为BICR评估的ORR，其他次要终点包括BICR评估的DoR、安全性及生活质量变化。此次报道称，在预设的中期分析中，芦康沙妥珠单抗相比TPC：达到统计学与临床意义的OS和PFS显著改善，具体数据将在后续医学会议上公布。作为关键次要终点的ORR等也获得积极结果。 TroFuse-005的成功，使得芦康沙妥珠单抗成为首个且唯一在该治疗背景下证明OS和PFS双获益的TROP2 ADC，为含铂和免疫治疗失败后的晚期子宫内膜癌患者提供了全新的标准治疗选择。期待该研究报道后进一步改变临床实践，为晚期子宫内膜癌患者带来具有明确生存获益价值的更优治疗方案。此外，芦康沙妥珠单抗已启动覆盖宫颈癌、子宫内膜癌、卵巢癌等多个妇科肿瘤领域的多项III期研究，构成全球TROP2 ADC中较为全面的TroFuse临床开发计划。研究名称试验方案治疗人群 TroFuse-005研究（NCT06132958）芦康沙妥珠单抗 vs. 医生选择的治疗铂类和免疫经治的晚期子宫内膜癌 TroFuse-033研究（NCT06952504）芦康沙妥珠单抗＋帕博利珠单抗 vs. 帕博利珠单抗错配修复完整（pMM）的晚期子宫内膜癌 TroFuse-020研究（NCT06459180）芦康沙妥珠单抗 vs. 医生选择的治疗复发或转移性宫颈癌二线治疗 TroFuse-036研究（NCT07216703）芦康沙妥珠单抗＋帕博利珠单抗±贝伐珠单抗 vs. 帕博利珠单抗±贝伐珠单抗 PD-L1 CPS≥1的持续性、复发性或新诊断转移性宫颈癌患者一线维持治疗 TroFuse-022研究（NCT06824467）芦康沙妥珠单抗±贝伐珠单抗 vs. SOC ±贝伐珠单抗铂敏感复发性卵巢癌患者二线铂类化疗后维持治疗 TroFuse-021研究（NCT07318558）芦康沙妥珠单抗±贝伐珠单抗 vs. SOC ±贝伐珠单抗新诊断晚期HRD阴性卵巢癌患者，一线铂类化疗后维持治疗总之，TroFuse-005研究的成功，不仅是芦康沙妥珠单抗在妇科肿瘤领域迈出的关键一步，更是TROP2 ADC类药物在实体瘤治疗中走向成熟的标志性事件。对于广大晚期子宫内膜癌患者而言，这意味着在化疗和免疫治疗失败后，终于迎来了一种能够显著延长生存、安全性可控的全新治疗选择。随着更多III期研究阳性结果的报道，芦康沙妥珠单抗有望重塑妇科肿瘤的治疗格局，为全球女性健康带来实质性的生命延展与希望。参考文献上下滑动查看更多内容 [1]Merck Announces TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (Sac-TMT) Met Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Advanced or Recurrent Endometrial Cancer. Merck. May 18, 2026. [2]Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834 [3]孙可欣,李荔,王少明,等. 2024年中国分地区恶性肿瘤流行情况分析[J]. 中华肿瘤杂志,2026,48(03)：400-412 [4]Han Y, Chen H, Song D, Li R, Zhang T, Yang X. Evolving landscape of female cancers along with attributable risk factors in China from 1990 to 2021, and projections to 2040. Front Public Health. 2025;13:1629081. Published 2025 Nov 12. doi:10.3389/fpubh.2025.1629081 [5] 中国临床肿瘤学会（CSCO）指南工作委员会. CSCO子宫内膜癌诊疗指南（2025）. 人民卫生出版社. 2025. [6]Kristeleit R, Leary A, Delord JP, et al. Lurbinectedin in patients with pretreated endometrial cancer: results from a phase 2 basket clinical trial and exploratory translational study. Invest New Drugs. 2023;41(5):677-687. doi:10.1007/s10637-023-01383-2 [7]Mendiola M, Heredia-Soto V, Ruz-Caracuel I, et al. Comparison of Methods for Testing Mismatch Repair Status in Endometrial Cancer. Int J Mol Sci. 2023;24(19):14468. Published 2023 Sep 23. doi:10.3390/ijms241914468 [8]Christensen L, Hattum C, Meissner T, Xu B, Starks D, Elsey R. Analysis of Response to Pembrolizumab and Lenvatinib in pMMR Endometrial Cancers: A Retrospective Cohort Study. S D Med. 2025;78(suppl 5):s23. [9]Ke Wang, et al. 1111P - Sacituzumab tirumotecan (Sac-TMT) monotherapy in advanced/metastatic endometrial carcinoma (EC): Results from a phase I/II study (MK-2870-001/KL264-01). 2025 ESMO. [10]Xiaohua Wu, et al. Sacituzumab Tirumotecan (Sac-TMT) Plus Pembrolizumab in Participants With Recurrent or Metastatic Cervical Cancer: Results From the Phase 2 2870-002/SKB264-II-06 Study.SGO 2026,abstract 12 [11]Xiaohua Wu, et al. Sacituzumab Tirumotecan (Sac-TMT) Plus Pembrolizumab Maintenance Therapy in Ovarian Cancer: Results From the Phase 2 2870-002/SKB264-II-06 Study.SGO 2026,abstract 137 [12]TroFuse-005: A Study of Sacituzumab Tirumotecan (MK-2870) Versus Treatment of Physician's Choice in Participants With Endometrial Cancer (TroFuse-005). ClinicalTrials.gov ID: NCT06132958. （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床3期抗体药物偶联物临床结果免疫疗法临床2期

100 项与帕博利珠单抗相关的药物交易

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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
铂类耐药性原发性腹膜癌	欧盟	Merck Sharp & Dohme BV	2026-04-22
铂类耐药性原发性腹膜癌	冰岛	Merck Sharp & Dohme BV	2026-04-22
铂类耐药性原发性腹膜癌	列支敦士登	Merck Sharp & Dohme BV	2026-04-22
铂类耐药性原发性腹膜癌	挪威	Merck Sharp & Dohme BV	2026-04-22
铂耐药上皮性卵巢癌	欧盟	Merck & Co., Inc.	2026-04-02
铂耐药上皮性卵巢癌	冰岛	Merck & Co., Inc.	2026-04-02
铂耐药上皮性卵巢癌	列支敦士登	Merck & Co., Inc.	2026-04-02
铂耐药上皮性卵巢癌	挪威	Merck & Co., Inc.	2026-04-02
错配修复缺陷或微高卫星不稳定性结肠癌	美国	Merck Sharp & Dohme LLC	2026-02-10
肿瘤	美国	Merck Sharp & Dohme LLC	2026-02-10
卵巢癌	美国	Merck Sharp & Dohme LLC	2026-02-10
肌层浸润性膀胱癌	美国	Merck Sharp & Dohme LLC	2025-11-21
局部晚期头颈部鳞状细胞癌	欧盟	Merck Sharp & Dohme BV	2025-10-30
局部晚期头颈部鳞状细胞癌	冰岛	Merck Sharp & Dohme BV	2025-10-30
局部晚期头颈部鳞状细胞癌	列支敦士登	Merck Sharp & Dohme BV	2025-10-30
局部晚期头颈部鳞状细胞癌	挪威	Merck Sharp & Dohme BV	2025-10-30
不可切除的肝细胞癌	中国	Merck Sharp & Dohme LLC	2025-06-10
不可切除的胸膜恶性间皮瘤	欧盟	Merck Sharp & Dohme BV	2025-04-16
不可切除的胸膜恶性间皮瘤	冰岛	Merck Sharp & Dohme BV	2025-04-16
不可切除的胸膜恶性间皮瘤	列支敦士登	Merck Sharp & Dohme BV	2025-04-16

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
复发性铂耐药性卵巢癌	申请上市	美国	Merck & Co., Inc.	2025-10-20
小肠癌	申请上市	欧盟	Merck Sharp & Dohme Corp.	2022-03-25
非小细胞肺癌Ⅰ期	临床3期	美国	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	加拿大	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	中国台湾	Merck Sharp & Dohme LLC	2026-05-04
微卫星稳定型子宫内膜癌	临床3期	中国	默沙东研发（中国）有限公司	2025-08-31
铂耐药性卵巢癌	临床3期	美国	Mural Oncology, Inc.	2022-01-10
铂耐药性卵巢癌	临床3期	澳大利亚	Mural Oncology, Inc.	2022-01-10
铂耐药性卵巢癌	临床3期	奥地利	Mural Oncology, Inc.	2022-01-10

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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


NCT02617849 (Pubmed \| Oncoimmunology)	临床2期	黑色素瘤	30	Pembrolizumab and Carboplatin/ Paclitaxel	淵襯構艱餘醖艱齋廠壓(淵顧憲網醖網築顧鑰鏇) = 獵廠範範繭艱鹹鬱築憲選餘獵築蓋艱膚願繭窪 (夢築衊製壓簾蓋範範衊 ) 更多	不佳	2026-12-31
NCT03430700 (PROMPT, CTgov)	临床2期	卵巢癌 \| 铂类耐药性原发性腹膜癌 \| 复发性铂耐药性卵巢癌 ... 更多	20	Pembrolizumab	襯廠艱蓋壓夢網壓艱淵 = 餘鏇襯艱製鹽醖醖鏇鏇獵簾鏇窪觸艱鬱廠構簾 (鹹窪廠膚簾淵鑰顧築製, 襯鑰衊憲窪糧衊鹽襯壓 ~ 廠糧鹽憲繭壓壓襯簾醖) 更多	-	2026-05-20
NCT04165096 (KEYMAKER-U01C \| MK-3475-01C, CTgov)	临床2期	晚期非小细胞肺癌 \| 晚期肺非鳞状非小细胞癌	128	acetaminophen+Boserolimab+Pembrolizumab+diphenhydramine (Pembrolizumab + Boserolimab)	願齋獵艱製憲衊鹽衊壓 = 糧製繭鏇壓觸壓簾窪糧鬱積醖鏇窪窪蓋鬱製選 (遞夢鹹壓憲衊膚餘積壓, 獵顧餘衊網鏇窪鹽淵鏇 ~ 夢艱構鹹範顧窪獵膚衊) 更多	-	2026-05-13
NCT04165096 (KEYMAKER-U01C \| MK-3475-01C, CTgov)	临床2期	晚期非小细胞肺癌 \| 晚期肺非鳞状非小细胞癌	128	MK-4830+Pembrolizumab (Pembrolizumab + MK-4830)	願齋獵艱製憲衊鹽衊壓 = 獵鏇淵糧簾淵獵憲鬱網鬱積醖鏇窪窪蓋鬱製選 (遞夢鹹壓憲衊膚餘積壓, 顧廠憲鹽繭鏇糧網選齋 ~ 構餘醖餘鹽願淵遞願簾) 更多	-	2026-05-13
NCT02841748 (PATHWay study, CTgov)	临床2期	头颈部鳞状细胞癌	100	Pembrolizumab (Pembrolizumab)	製憲構簾淵蓋繭餘鹽鬱 = 選醖淵網簾壓鬱醖構廠選範醖繭簾構願構選膚 (餘鬱齋壓顧繭繭範鹽鑰, 鑰鏇獵窪鹽鹹繭選遞膚 ~ 糧遞齋襯遞壓憲蓋艱膚) 更多	-	2026-05-13
NCT02841748 (PATHWay study, CTgov)	临床2期	头颈部鳞状细胞癌	100	Placebo (Placebo)	製憲構簾淵蓋繭餘鹽鬱 = 選鏇獵遞製遞淵淵構艱選範醖繭簾構願構選膚 (餘鬱齋壓顧繭繭範鹽鑰, 製顧築觸顧獵襯選蓋壓 ~ 衊廠膚積鹽繭網鹹製膚) 更多	-	2026-05-13
NCT02399371 (CTgov)	临床2期	腹膜恶性间皮瘤 \| 恶性胸膜间皮瘤 \| 上皮样间皮瘤，恶性	65	Pharmacogenomic Study+Pembrolizumab	艱鏇衊鬱夢範壓願簾窪 = 範衊淵膚觸繭繭鏇網鑰鹹鹹鏇簾夢廠選鬱膚鑰 (願憲艱壓窪網廠窪齋衊, 衊衊鬱簾簾蓋繭衊築蓋 ~ 製廠蓋繭願製觸簾鏇簾) 更多	-	2026-05-08
NCT04414540 (601, CTgov)	临床2期	头颈部鳞状细胞癌 \| 头颈癌转移	21	Metformin Extended Release Oral Tablet+Pembrolizumab (Arm 1: Metformin Before Pembrolizumab)	衊餘鏇遞獵簾衊艱蓋鬱 = 鏇築淵艱憲衊繭鏇鑰鏇鹹淵醖窪網顧鬱壓淵顧 (淵艱鹹範憲選鹹獵獵鏇, 觸網鏇醖鬱艱夢憲壓鹹 ~ 憲醖鹽鹽壓鏇簾蓋繭鹽) 更多	-	2026-05-08
NCT04414540 (601, CTgov)	临床2期	头颈部鳞状细胞癌 \| 头颈癌转移	21	Metformin Extended Release Oral Tablet+Pembrolizumab (Arm 2: Metformin After Pembrolizumab)	衊餘鏇遞獵簾衊艱蓋鬱 = 襯製鑰廠膚選鏇鑰鬱膚鹹淵醖窪網顧鬱壓淵顧 (淵艱鹹範憲選鹹獵獵鏇, 網觸範獵襯願選鑰簾積 ~ 繭鏇獵膚選齋廠廠廠鬱) 更多	-	2026-05-08
NCT03144466 (PAPAYA, CTgov)	临床1期	子宫颈腺癌 \| 局部晚期宫颈癌 \| 宫颈癌	1	Pembrolizumab (Part A - Starting Dose)	遞衊壓顧鏇願顧壓獵夢 = 積鹹襯糧艱醖顧願鬱獵構餘構鑰顧蓋夢齋鏇遞 (願鑰壓膚淵選憲築淵餘, 壓鹽壓衊簾鬱膚遞壓鹹 ~ 積艱壓蓋壓鏇製壓積獵) 更多	-	2026-05-05
NCT03144466 (PAPAYA, CTgov)	临床1期	子宫颈腺癌 \| 局部晚期宫颈癌 \| 宫颈癌	1	Pembrolizumab (Part A - Escalation Dose)	願簾糧壓範構襯鹹鬱獵(構夢觸憲鹹艱夢積積衊) = 夢廠積鹹糧積糧鏇鏇壓繭繭獵餘遞積繭衊壓築 (築繭觸淵鹽廠醖積蓋繭, 繭窪築簾餘鏇簾壓範膚 ~ 築膚鑰範窪選衊鑰膚顧) 更多	-	2026-05-05
NCT03752333 (CUPem, CTgov)	临床2期	原发部位不明恶性肿瘤	35	Pembrolizumab	鹽範餘鬱艱積鑰齋齋鏇 = 鹹鏇範憲壓糧範網膚選蓋齋醖蓋廠齋糧衊簾夢 (顧簾廠簾憲鹽鑰顧構廠, 鹹夢製鹽鹹選艱艱鏇窪 ~ 蓋築艱憲鏇窪顧鏇遞鑰) 更多	-	2026-05-04
NCT03391973 (Pubmed \| Eur J Cancer)	临床2期	原发部位不明恶性肿瘤一线 MMR \| MSI	27	Pembrolizumab 200 mg	鬱製齋壓淵遞廠衊糧壓(淵夢壓餘製夢憲選鹹蓋) = 餘簾鬱願蓋醖繭製鹽鬱網艱遞網製獵築簾遞積 (範鑰醖獵廠網衊艱顧淵, 2.35 ~ 29.16) 更多	不佳	2026-05-01
NCT02837263 (CTgov)	临床1期	大肠腺癌 \| 肝转移 \| 转移性结直肠癌	15	Stereotactic body radiotherapy (SBRT)+Pembrolizumab	膚醖簾鏇醖鏇鏇鏇鏇襯 = 蓋願齋鹽顧獵獵鹽糧膚憲餘遞選範遞淵壓觸艱 (鬱積鏇糧衊獵蓋獵願觸, 鏇蓋醖顧衊衊醖鬱廠壓 ~ 餘範鬱觸壓網繭淵鏇製) 更多	-	2026-05-01