A Biomarker Enrichment Trial of Anti-EGFR Agents in Patients With Advanced Colorectal Cancer (aCRC) With Wild-type RAS and Right Primary Tumour Location (Right-PTL).

The aim of this trial is to assess the feasibility of EREG/AREG assessment as a clinical diagnostic standard, used to guide clinical decision making in right-PTL, RAS-wt aCRC. Further to this, the aim is to determine whether EREG/AREG status identifies right-PTL participants who will benefit from the addition of anti-EGFR therapy to first-line chemotherapy.

开始日期2026-04-15

申办/合作机构

Gruppo Oncologico del Nord-Ovest

[+1]

NCT07332481

/ Not yet recruiting临床3期

A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-1)

The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include:
Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.
Intervention Form: Film-coated tablet.

开始日期2026-03-27

申办/合作机构

EMD Serono Research & Development Institute, Inc.

[+1]

NCT07225660

/ RecruitingN/AIIT

A Randomized Blinded Controlled Trial Assessing Hormonal Optimization: Late vs. Immediate Start After Discontinuation of Oral Contraceptives in Assisted Reproductive technologY (HOLIDAY)

HOLIDAY is a two-arm, parallel-group, multi-center, randomized trial in which subjects undergoing planned oocyte cryopreservation will be randomized to receive either a 2-month pause of Combined Hormonal Contraceptives (CHC) or immediate start (without a pause).

开始日期2026-02-25

申办/合作机构

Shady Grove Reproductive Science Center PC

[+1]

100 项与 Merck KGaA 相关的临床结果

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1,431

项与 Merck KGaA 相关的文献（医药）

2026-03-16·Future Oncology

Avelumab real-world use in advanced Merkel cell carcinoma: a systematic review and non-comparative meta-analysis

Review

作者: Moradian, Hoora ; Freitag, Andreas ; Rutherford, Megan ; Kearney, Mairead ; Kwon, Christina ; Lan, Zhiyi

AIM:

Programmed death (ligand) 1 inhibitors (e.g., avelumab, pembrolizumab, and retifanlimab) are first-line treatment options for patients with locally advanced or metastatic Merkel cell carcinoma (MCC). In the absence of comparative and randomized trials, we aimed to systematically identify and synthesize real-world evidence (RWE) on the effectiveness and safety of immunotherapies in patients with advanced MCC.

METHODS & MATERIALS:

MEDLINE and Embase searches were conducted for observational RWE studies in locally advanced or metastatic MCC from January 2017 to December 2023. Avelumab was the only immunotherapy with sufficient data for analysis. Landmark 12-month overall survival (OS) and progression-free survival (PFS) were assessed by meta-analysis.

RESULTS:

Screening of 1731 records identified 37 publications eligible for inclusion (16 unique studies), of which eight were included in the meta-analysis. In line with results from the JAVELIN Merkel 200 trial, pooled 12-month OS rates of 77.7% in stage III and 63.0% in stage IV MCC and 12-month PFS rates of 53.3% and 39.3%, respectively, were estimated. Although safety data were insufficient for meta-analysis, two retrospective studies reported lower adverse event rates than JAVELIN Merkel 200.

CONCLUSIONS:

The results of this study support broader use of avelumab in advanced MCC.

2026-03-01·CLINICAL PHARMACOLOGY & THERAPEUTICS

Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib

Article

作者: Seithel‐Keuth, Annick ; Tolcher, Anthony W. ; Gounaris, Ioannis ; Strotmann, Rainer ; Gao, Wei ; Enderlin, Marta ; Locatelli, Giuseppe ; Bolleddula, Jayaprakasam ; Benincosa, Lisa ; Hellmann, Farina ; Zutshi, Anup ; Zimmermann, Astrid ; Diderichsen, Paul Matthias ; Yap, Timothy A. ; Mukker, Jatinder Kaur ; de Bono, Johann S. ; Szucs, Zoltan ; Kareva, Irina ; Venkatakrishnan, Karthik ; Hicking, Christine ; Plummer, Ruth

We present model‐informed selection of the recommended dose for expansion (RDE) of investigational oral ATR inhibitor tuvusertib, by integrating clinical pharmacokinetics (PK), pharmacodynamics (PD), and safety data from DDRiver Solid Tumors 301 trial Part A1 (NCT04170153). A population PK (POPPK) model was developed to characterize PK and hemoglobin (HGB) reduction after multicycle treatment was simulated using a semi‐mechanistic, multivariate POPPK/PD model of reticulocyte (RET), red blood cell (RBC), and HGB dynamics. A semi‐mechanistic PK‐efficacy model characterized concentration‐dependent tumor growth inhibition (TGI) in ARID1A mutant xenograft models. The clinical exposure‐PD relationship was described for phosphorylated Ser‐139 residue of the histone variant H2AX (γH2AX) as a biomarker of ATR inhibition. POPPK simulations predict the average steady‐state concentrations to exceed phosphorylated checkpoint kinase 1 (pCHK1) IC 90 at 100–180 mg once daily (QD) and 180 mg QD 2 weeks (w) on/1w off. Exposure‐related PD suggested target engagement of ≥80% at ≥130 mg QD. POPPK/PD modeling showed partial HGB recovery and lower rates of Grade ≥3 anemia after multicycle treatment with 180 mg QD 2w on/1w off vs. 130 mg and 180 mg QD. Lesser HGB reduction was predicted for 100 mg QD vs. higher QD doses. Translational modeling indicated no effect of the one‐week dosing break on TGI at 180 mg QD. The analysis supports tuvusertib 180 mg QD 2w on/1w off as the RDE and 100 mg QD as the no‐regret dose for clinical evaluation. This example underscores the value of integrated quantitative pharmacology analyses to inform dose selection using a totality of evidence approach.

2026-03-01·JOURNAL OF CHROMATOGRAPHY A

Multiresidual analysis of pesticides in white table grapes using hyphenated chromatographic techniques: Compliance and risk assessment

Article

作者: Obkircher, Markus ; Zoccali, Mariosimone ; Rinaldi, Giorgia ; Ferracane, Antonio ; Rigger, Romana ; Donnarumma, Danilo ; Mondello, Luigi

Grapes are widely cultivated and consumed, requiring pesticide control to ensure consumer safety. Herein we report a simplified workflow for detecting 236 pesticides in white table grapes within the EU multi-annual control programme, along with chronic, acute and cumulative risk assessments. The method involved two complementary analytical platforms: low-pressure gas chromatography (LP-GC) for volatile/semi-volatile pesticides and ultra-high-performance liquid chromatography (UHPLC) for polar/thermally labile pesticides, both coupled to triple quadrupole mass spectrometry (QqQMS). The methods were validated in terms of linearity (correlation coefficients ≥0.998 for all analytes), extraction recovery (mean recoveries of 70-120 % for >90 % of pesticides), precision (intra- and inter-day relative standard deviations ≤20 % for all validated concentrations), trueness (in the range 63-135 %), and limit of quantification (ranging from 0.002 to 0.01 mg Kg^-1 for LP-GC-QqQMS and from 0.002 to 0.05 mg Kg^-1 for UHPLC-QqQMS). Analysis of 20 samples detected 23 pesticides, five of which exceeded MRLs. Risk assessment showed that parathion-methyl poses unacceptable chronic and acute risks (exceedance up to 234 % and 193 % respectively), especially for children under <10 years old and toddlers due to their high consumption and low body weight. This highlights the need for stricter monitoring and regulatory measures to minimize pesticide exposure to widely consumed fruits.

3,071

项与 Merck KGaA 相关的新闻（医药）

2026-03-24

·同写意

药明康德，超越想象

财报抗体药物偶联物

2026-03-24

·同写意

从商业化跨越到全球领跑，银诺医药（2591.HK）解码超长效GLP-1的稀缺价值

2026-03-24

·同写意

驯鹿生物CAR-T药品伊基奥仑赛注射液治疗2/3线多发性骨髓瘤临床试验申请获日本PMDA默示许可 | 会员动态

100 项与 Merck KGaA 相关的药物交易

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