A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab vs. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer

This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol).
Approximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors:
* Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer)
* ECOG score at baseline (0 vs 1)
* Geographic region (Asia vs ROW)

开始日期2026-12-01

申办/合作机构

Evergreen Therapeutics, Inc

NCT05106127

/ Not yet recruiting临床2期

A Phase 2, Open-Label, Safety Lead-In With Long Term Safety Study of EG-007, Added to the Combination of Lenvatinib Plus Pembrolizumab

This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients.
A safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.

开始日期2026-08-01

申办/合作机构

Evergreen Therapeutics, Inc

NCT07460206

/ Not yet recruiting临床2期IIT

Pembrolizumab Plus Lenvatinib in REcurrent ccRCC Patients Failing permbroLizUmab aDjuvant trEatment - PRELUDE Study

This study is being performed as a single-arm open-label study in order to provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with advanced ccRCC who have progressed on Pembrolizumab as their prior therapy in the adjuvant RCC setting.

开始日期2026-08-01

申办/合作机构-

100 项与帕博利珠单抗相关的临床结果

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9,577

项与帕博利珠单抗相关的文献（医药）

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 ; Johnson, Geoffrey ; Qian, Feng ; Tang, Yuexin ; Bensimon, Arielle G. ; Adkins, Douglas ; Zheng, Dandan ; Tzontcheva, Anjela ; Benjamin, Kimberly ; 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.

2026-12-31·OncoImmunology

A mixed inflammatory peripheral signature defines clinical outcomes in a phase II trial combining pembrolizumab with paclitaxel and carboplatin in melanoma

Article

作者: Cocolakis, Eftihia ; Cailhier, Jean-François ; Lapointe, Réjean ; Thébault, Paméla ; Lepage, Stéphanie ; Shechtman, Yelena ; Letendre, Caroline ; Le, Huy ; Dionne, Jeanne ; Jamal, Rahima ; Bélanger, Karl ; Lambert, Caroline ; Miller Jr, Wilson H.

Checkpoint blockade of PD-1 with pembrolizumab provides long-term survival to a significant proportion of patients with metastatic melanoma. Pembrolizumab has been successfully used in combination with chemotherapy in non-small-cell lung cancer to increase the response rate. This phase II trial combined pembrolizumab with carboplatin/paclitaxel (CP) to assess its safety and efficacy, and to identify correlates of responses. Thirty patients without prior immunotherapy for unresectable/metastatic melanoma were treated with pembrolizumab and CP. Peripheral blood was collected at baseline and after 2 cycles to characterize systemic immune activity by multiplex assays and flow cytometry. Seventy percent of patients received all 4 cycles of CP; 87% received pembrolizumab for 2 y or until progression. Grade 3 and higher adverse events (AEs) occurred in 50% of the patients. The overall response rate (ORR) and disease control rate (DCR) by irRC criteria were 43% and 53%, respectively. Median overall survival (OS) was 23.8 months. Objective response was associated with a lower frequency of naive CD8 T cells and low plasma CCL3 at baseline, along with a larger proportion of mature NK cells and of CD4 T cells expressing BTLA or LAIR-1. Survival rate was higher for patients with lower baseline of IL-6, IL-8, and CD4⁺CD39⁺ T cells. Following treatment, pro-inflammatory soluble factors increased in both responders and non-responders. Addition of CP to pembrolizumab in this study did not appear to result in a response or survival advantage and was less tolerable than immunotherapy alone. Correlative data point to peripheral signals to investigate further as potential biomarkers. Trial registration: clinicaltrials.gov, NCT02617849, registered on December 1st, 2015.

12,364

项与帕博利珠单抗相关的新闻（医药）

10 小时之前

·FiercePharma

Another AstraZeneca Emerald glimmers as Imfinzi, Imjudo delay liver cancer progression

The Emerald-3 showing draws a resemblance to AstraZeneca’s Emerald-1 readout in the same locoregional treatment setting among liver cancer patients eligible for TACE. Another green light appears increasingly within reach for AstraZeneca’s Emerald program after a combo regimen featuring the company’s immunotherapy duo, Imfinzi and Imjudo, showed benefit in certain liver cancer patients. Results from the phase 3 Emerald-3 trial showed that the combination, paired with transarterial chemoembolizaton (TACE) and Lenvima, significantly improved progression-free survival (PFS) versus TACE alone in patients with unresectable locoregional hepatocellular carcinoma. Lenvima is a multikinase inhibitor sold by Merck & Co. and Eisai.But whether AZ has struck gold with Emerald-3 remains to be seen. Overall survival (OS), a secondary endpoint that will be a key consideration for the FDA, was immature at the interim analysis, although AZ highlighted a trend toward improvement in its April 2 announcement. In two ways, the Emerald-3 showing draws a resemblance to AZ’s Emerald-1 readout in the same locoregional treatment setting among liver cancer patients eligible for TACE. Two years ago, the Emerald-1 trial hit its primary endpoint, showing that a cocktail of Imfinzi, Avastin and TACE reduced the risk of progression or death by 23% versus TACE alone. At that time, OS was also immature, and AZ’s oncology R&D chief, Susan Galbraith, Ph.D., flagged that patient survival data are crucial in this locoregional setting. Case in point: Despite a PFS win, Merck & Co. last year abandoned hopes for a similar liver cancer approval for its Keytruda-Lenvima-TACE regimen after it failed to improve OS compared with TACE alone.Emerald-1 still hasn’t reported its final OS data, and the study has not graduated to the regulatory submission batch in AZ’s most recent earnings report in February. In addition, like Emerald-1, Emerald-3 has a second experimental arm. In this cohort, Imfinzi, Imjudo and TACE—without Lenvima—showed what AZ called “strong trends” toward improved PFS and OS, although these analyses were not formally tested. Previously, in Emerald-1, only the Avastin-containing triplet beat TACE, while Imfinzi-TACE failed to move the needle. AZ is discussing the latest Emerald-3 data with global regulatory authorities while waiting for final results from the trial’s key secondary endpoints, Galbraith said in an April 2 statement.As for Emerald-1, an AZ spokesperson said the company will share additional data in the future and will update its regulatory discussion plans as appropriate. Liver cancer helped AZ’s CTLA-4 agent Imjudo break into the market in 2022 as part of a combination with Imfinzi in unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. Patients who are eligible for embolization have an earlier stage of disease. In 2026, more than 200,000 patients belong to this category, according to data cited by AZ—however, most patients who receive the procedure experience progression or recurrence within six to ten months.The British pharma also has a third Emerald. Called Emerald-2, the phase 3 study is testing Imfinzi with Avastin in adjuvant liver cancer, with its data expected in the second half of 2026. As for the Imfinzi-Imjudo duo, AZ also expects readouts this year from its Nile trial in first-line metastatic bladder cancer and from its Volga study assessing a neoadjuvant regimen in cisplatin-ineligible muscle-invasive bladder cancer. Both will need to live up to the high expectations set by the combination of Merck & Co.’s Keytruda and Pfizer and Astellas’ antibody-drug conjugate Padcev.For AZ’s broader oncology portfolio, the company is bracing for an upcoming FDA advisory committee meeting that will dig into two separate applications for its oral SERD med camizestrant and the AKT inhibitor Truqap. The high-stakes first-line non-small cell lung cancer readout for Daiichi Sankyo-partnered Datroway from the Avanzar trial is also expected this year.

临床3期临床结果抗体药物偶联物临床2期

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天演药业宣布与Incyte达成临床合作

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
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
不可切除的胸膜恶性间皮瘤	挪威	Merck Sharp & Dohme BV	2025-04-16
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

未上市

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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
铂耐药上皮性卵巢癌	临床3期	美国	Mural Oncology, Inc.	2022-01-10
铂耐药上皮性卵巢癌	临床3期	澳大利亚	Mural Oncology, Inc.	2022-01-10
铂耐药上皮性卵巢癌	临床3期	奥地利	Mural Oncology, Inc.	2022-01-10
铂耐药上皮性卵巢癌	临床3期	比利时	Mural Oncology, Inc.	2022-01-10
铂耐药上皮性卵巢癌	临床3期	加拿大	Mural Oncology, Inc.	2022-01-10
铂耐药上皮性卵巢癌	临床3期	捷克	Mural Oncology, Inc.	2022-01-10
铂耐药上皮性卵巢癌	临床3期	法国	Mural Oncology, Inc.	2022-01-10
铂耐药上皮性卵巢癌	临床3期	德国	Mural Oncology, Inc.	2022-01-10

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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	餘鑰鏇淵製鹽窪顧遞憲(鹽顧觸範築膚襯憲鑰選) = 淵鹹齋艱積繭夢憲築淵積遞齋範壓廠獵鹽衊鹽 (鏇顧願夢蓋糧壓壓觸觸 ) 更多	不佳	2026-12-31
AACR2026	N/A	转移性非小细胞肺癌一线	11,758	Atezolizumab	網齋醖蓋製壓鑰廠壓齋(獵築鏇鏇齋願範窪簾選) = 艱夢襯鬱襯製製遞糧壓選繭餘鹹壓構鹽願廠膚 (醖廠蓋壓艱壓餘醖鏇願 ) 更多	不佳	2026-04-21
				Pembrolizumab	網齋醖蓋製壓鑰廠壓齋(獵築鏇鏇齋願範窪簾選) = 築鏇鑰膚鹹淵鑰艱範憲選繭餘鹹壓構鹽願廠膚 (醖廠蓋壓艱壓餘醖鏇願 ) 更多
NCT03457948 (AACR2026)	临床2期	胃肠胰神经内分泌肿瘤	26	177Lu-DOTATATE plus pembrolizumab	衊遞憲積願艱願觸繭淵(製顧蓋壓窪顧艱夢壓餘) = significantly elevated (p<0.05) and exhibited prominent clonal expansion in epNET responders, particularly post treatment 膚艱願積願觸築鬱壓網 (製選積築壓壓糧醖選衊 ) 更多	积极	2026-04-21
AACR2026	临床2/3期	膀胱癌一线	200	ICI-only regimen(Durvalumab, Durvalumab+Tremelimumab, Pembrolizumab)	淵醖構醖蓋鏇艱構餘獵(鹹構襯鏇廠選鏇蓋獵構): HR = 1.92 (95.0% CI, 1.63 ~ 2.25) 更多	不佳	2026-04-21
				chemotherapy
AACR2026	临床2/3期	晚期头颈部鳞状细胞癌一线	398	PembrolizumabDurvalumabNivolumabumaIpilimumabTremelimumab + PembrolizumabDurvalumabNivolumab + IpilimumabTremelimumab + PembrolizumabDurvalumabNivolumabbIpilimumabTremelimumab + PembrolizumabDurvalumabNivolumabb +IpilimumabTremelimumab	壓憲膚積鹹築範蓋網範(遞鹹範鬱糧壓鏇選網鹹): HR = 1.73 (95.0% CI, 1.49 ~ 2.01) 更多	不佳	2026-04-21
				Chemotherapy
NCT03983668 (CTgov)	临床1/2期	难治性霍奇金淋巴瘤 \| 非霍奇金淋巴瘤 \| 淋巴瘤	14	CMP-001+Pembrolizumab	範簾顧遞膚願鑰襯鑰範 = 淵簾獵窪艱蓋壓範憲網積衊齋淵齋淵製遞鏇繭 (艱齋膚獵齋鑰艱憲齋醖, 積鏇夢選醖鹹築觸積鬱 ~ 衊製膚網網構齋鹹憲獵) 更多	-	2026-03-30
NCT03197506 (CTgov)	临床2期	多形性胶质母细胞瘤	52	temozolomide+pembrolizumab (Group 1 Dose Level 1 Cohort 1)	膚壓積選鏇選網夢遞積 = 蓋選鑰鬱糧網繭製壓鹹襯醖顧遞鏇廠願餘糧範 (網糧鏇觸壓構範願艱壓, 窪築膚醖膚衊獵製襯鬱 ~ 積鹹淵選鏇製鹽遞網鑰) 更多	-	2026-03-25
				temozolomide+pembrolizumab (Group 1 Dose Level 1 Cohort 2)	膚壓積選鏇選網夢遞積 = 網膚衊艱範壓獵艱窪窪襯醖顧遞鏇廠願餘糧範 (網糧鏇觸壓構範願艱壓, 醖廠鬱簾構壓醖餘壓蓋 ~ 繭願襯淵範製製糧範廠) 更多
NCT03568058 (CTgov)	临床1期	晚期癌症	25	Personalized Vaccine+Pembrolizumab (Arm A: Personalized Vaccine and Anti- PD-1 Administered Concurrently at the Start of Study Therapy.)	窪構鏇網鑰壓壓築鏇網 = 築鑰遞鹹淵醖獵範壓襯鹹簾餘鹽鹹窪餘網構憲 (築膚憲夢憲襯鬱築範範, 壓築構蓋構艱窪繭齋夢 ~ 齋積衊選齋壓蓋醖廠鑰) 更多	-	2026-03-24
				Personalized Vaccine+Pembrolizumab (Arm B: Anti-PD-1 Antibody for 6 Weeks Followed by Personalized Vaccine Therapy.)	衊獵醖窪獵鬱鬱窪糧廠 = 積觸範齋餘鹽壓鏇膚簾觸製遞餘蓋網築積簾醖 (齋鑰鑰選鏇鏇構選鑰選, 壓糧積簾觸憲鹽壓製鏇 ~ 淵膚選簾築鑰範簾鹽網) 更多
NCT03753659 (IMMULAB \| IKF-IMMULAB, CTgov)	临床2期	肝细胞癌	30	Radio Frequency Ablation (RFA)+Pembrolizumab	獵憲構獵餘範鹽鏇淵網 = 簾淵鬱襯製夢糧艱鬱膚獵壓醖積選糧繭範繭獵 (網積窪製繭構糧鹽壓淵, 窪網廠醖觸齋鑰窪淵鏇 ~ 壓鑰衊窪網積糧夢選構) 更多	-	2026-03-23
NCT04637594 (IMAGINE, CTgov)	临床3期	膀胱尿路上皮癌 \| 转移性尿道尿路上皮癌 \| 局部晚期尿路上皮癌 ... 更多	3	Nivolumab+Avelumab+Atezolizumab+Pembrolizumab+Durvalumab (Arm A (Immune Checkpoint Inhibitor))	鏇窪鬱簾衊憲鏇憲膚獵 = 鏇衊顧齋齋壓夢齋遞範壓衊遞網製窪鹹蓋窪觸 (鏇簾鬱鏇淵窪遞壓淵鹽, 簾繭艱夢觸鑰鏇鑰壓繭 ~ 襯願獵餘簾鑰築蓋鏇醖) 更多	-	2026-03-20
				Nivolumab+Avelumab+Atezolizumab+Pembrolizumab+Durvalumab (Arm B (Immune Checkpoint Inhibitor))	鏇窪鬱簾衊憲鏇憲膚獵 = 遞夢夢窪衊艱獵願鹹獵壓衊遞網製窪鹹蓋窪觸 (鏇簾鬱鏇淵窪遞壓淵鹽, 糧遞鹽夢齋鑰窪獵夢齋 ~ 襯膚範選艱膚糧鏇網淵) 更多