Project description:Biomarker study for a phase 1, Open-Label, multicenter trial of azacitidine (CC-486) plus R-CHOP in subjects with high-risk previously untreated diffuse large B-cell lymphoma
Project description:Resistance to immune checkpoint inhibitors (ICI) in cancer patients is not fully understood and predictive biomarkers are lacking. MELANFα (NCT03348891) is an open-label, prospective, multicenter cohort of 60 patients with advanced melanoma receiving ICI (bitherapy: ipilimumab + nivolumab; monotherapy: pembrolizumab or nivolumab). In this study we collected blood from patients taken at baseline (week0) and 6 weeks after treatment initiation (week6), isolated peripheral blood monuclear cells and assessed the impact of treatment systemic immune responses to identify potential markers of response/resistance.
Project description:We conducted a multicenter, open-label, single-arm phase II trial (SCan Study) to evaluate the efficacy and safety of canakinumab in 5 Japanese patients with Schnitzler syndrome (SchS), based on a similar study conducted in Germany. In this trial, single-cell RNA sequencing (scRNA-seq) of peripheral blood were performed in 2 cases to identify IL1B-expressing cells, using 10x Genomics scRNA-seq.
Project description:In the current study, we used exon arrays and clinical samples from a previous trial (SAKK 19/05) to investigate the expression variations at the exon-level of 3 genes potentially playing a key role in modulating treatment response (EGFR, KRAS, VEGFA). Exon-level biomarkers for the response to targeted therapy bevacizumab/erlotinib were identified in patients with metastatic non-small cell lung cancer Multicenter, prospective, open-label, single-arm, phase II trial.
Project description:We conducted a multicenter, open-label, single-arm phase II trial (SCan Study) to evaluate the efficacy and safety of canakinumab in 5 Japanese patients with Schnitzler syndrome (SchS), based on a similar study conducted in Germany. As part of this study, spatial transcriptomics of urticarial rash skin lesions were performed before treatment in 2 cases to identify IL1B-expressing cells. The spatial transcriptomics analysis was conducted using the 10x Genomics Xenium platform.
Project description:Afatinib is a pan-HER inhibitor that improved progression-free-survival (PFS) in recurrent HNSCC versus methotrexate: median PFS 2.6 versus 1.7 months (LUX H&N 1 trial). This study is a translational research linked to EORTC 90111 afatinib trial, an open-label, randomized, multicenter, phase II window of opportunity trial. Treatment-naïve HNSCC patients selected for primary curative surgery were randomized (5:1 ratio) to receive Afatinib during 14 days (day -15 until day -1) before surgery (day 0) or no treatment. Tumour biopsies, FDG/PET, and MRI were performed at diagnosis and at surgery. The primary end point was metabolic FDG-PET/CT response, defined according to EORTC guidelines.
Project description:PROgECT (ClinicalTrials.gov Identifier: NCT01988961) was a multicenter, open-label study evaluating the accuracy of a probe-set panel in predicting response to golimumab treatment in participants with moderately to severely active ulcerative colitis (UC). Biopsy samples (collected 15 to 20 cm from the anal verge) were taken at screening from 84 patients and used for RNA extraction and profiling by microarrays. All patients enrolled in the study received the approved induction dose regimen of subcutaneous (SC) golimumab.