162TiP A phase I study evaluating BI 765063, a first in class selective myeloid SIRPa inhibitor, as standalone and in combination with BI 754091, a programmed death-1 (PD-1) inhibitor, in patients with advanced solid tumours
This study comprises a dose escalation (step 1) to determine the Dose-Limiting Toxicities, Maximum Tolerated Dose (MTD), and Recommended phase II Dose (RP2Ds) of BI 765063 monotherapy and with BI 754091, and dose-confirmation expansion cohorts (step 2). In Step 1, ascending doses of BI 763063 every 3 weeks intravenously (iv) using a Bayesian approach with overdose control are tested. When MTD determined, BI 763063 will be tested with BI 754091, a PD-1 mAb inhibitor. In step 2, 2 parallel randomized, non-comparative mono and combination cohorts will further confirm the RP2Ds and assess the safety and preliminary efficacy (R...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
LBA3 Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo as first-line (1L) treatment (tx) for advanced non-small cell lung cancer (aNSCLC): CheckMate 227 - part 2 final analysis
ConclusionCheckMate 227 Part 2 did not meet the primary endpoint of OS for NIVO + chemo vs chemo in NSQ NSCLC. Descriptive analyses showed longer OS with NIVO + chemo in all randomized pts and SQ NSCLC. No new safety signals were observed.Clinical trial identificationNCT02477826; Release date: June 23, 2015.Editorial acknowledgementWriting and editorial assistance was provided by Namiko Abe, PhD, of Caudex, funded by Bristol-Myers Squibb.Legal entity responsible for the studyBristol-Myers Squibb.FundingBristol-Myers Squibb.DisclosureL. Paz-Ares: Honoraria (self): Roche, MSD, Lilly, Novartis, Boehringer Ingelheim, AstraZene...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
128TiP VCN-01 plus durvalumab in subjects with recurrent/metastatic head & amp; neck squamous cell carcinoma (R/M HNSCC): Phase I clinical trial
AbstractBackgroundVCN-01 is an oncolytic adenovirus with replication restricted to cells with a nonfunctional retinoblastoma pathway. Upon selective replication VCN-01 expresses the matrix remodeling-enzyme hyaluronidase to enhance virus spreading and tumor uptake of different therapeutics, including immune check-point inhibitors. In a phase I performed in pancreatic carcinoma VCN-01 reached tumors after systemic administration and induced CD8-infiltration, tumor inflammation and PD-1/PD-L1 up-regulation. We hypothesize these intratumor effects may help to overcome the observed resistance to Durvalumab and other PD-(L)-1 c...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
127TiP PROPEL: A phase I/II trial of bempegaldesleukin (NKTR-214) in combination with pembrolizumab (pembro) in patients (pts) with advanced solid tumours
AbstractBackgroundCheckpoint Inhibitors (CPIs), are now part of standard treatment in many advanced solid tumors, including metastatic non-small cell lung cancer (mNSCLC). However, novel, more effective CPI combinations are needed to broaden, deepen, and prolong responses, especially for pts with poor prognostic features or negative predictive clinical factors for CPI benefit, including PD-L1 negative (-) status. Bempegaldesleukin (BEMPEG; NKTR-214) is a CD122-preferential IL-2 pathway agonist designed to provide sustained signaling through the IL-2 βγ receptor. BEMPEG + CPI has demonstrated promising efficacy and can co...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
173TiP PECan study, imaging PD-L1 in cancer: A tool for measuring response to immunotherapy?
This study is now open to recruitment with reporting expected late 2020.Clinical trial identificationUK IRAS ID 256684.Legal entity responsible for the studyKing's College London and Guy's and St Thomas' NHS Foundation Trust.FundingDepartment of Cancer Imaging, King's College London, UK with funding from NanoMab Technology Limited, China.DisclosureG. Chand: Advisory / Consultancy, Shareholder / Stockholder / Stock options: NanoMab Technology Limited. H.H. Ting: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment, Officer / Board of Directors: NanoMab Technology Limited. G. Cook: Research...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
82P Real-world survival with first-line (1L) chemotherapy in patients (pts) with advanced non-small cell lung cancer (aNSCLC)
ConclusionRW OS in broad histology-based populations of 1L chemo pts was similar to meta-analysis estimates from corresponding trial populations. However, RW OS in TPS-based populations, where biomarker information is more commonly available in recent cohorts, was numerically longer than in the corresponding meta-analysis trial populations. Additional analyses are planned to assess IO-chemo in RW and to determine the influence of post-progression immunotherapy and imbalances in prognostic factors on chemo treatment group outcomes.Legal entity responsible for the studyBristol-Myers Squibb.FundingBristol-Myers Squibb.Disclos...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
Uncrewed aircraft systems versus motorcycles to deliver laboratory samples in west Africa: a comparative economic study
Publication date: January 2020Source: The Lancet Global Health, Volume 8, Issue 1Author(s): Walter O Ochieng, Tun Ye, Christina Scheel, Aun Lor, John Saindon, Sue Lin Yee, Martin I Meltzer, Vikas Kapil, Kevin KaremSummaryBackgroundTransportation of laboratory samples in low-income and middle-income countries is often constrained by poor road conditions, difficult geographical terrain, and insecurity. These constraints can lead to long turnaround times for laboratory diagnostic tests and hamper epidemic control or patient treatment efforts. Although uncrewed aircraft systems (UAS)—ie, drones—can mitigate some of these t...
Source: The Lancet Global Health - December 14, 2019 Category: International Medicine & Public Health Source Type: research
Growing and Nurturing Your Evaluation Business When Your Independent Consultancy Becomes an Employer
AbstractLessons learned from 19 years building an evaluation consulting business can inform other business owners. The Improve Group has grown from a one ‐woman consultancy to an employer of more than thirty people. Staying grounded in a mission and a clear set of values is a guiding principle that has guided and informed growth. Sharing power with staff—to operate democratically while also leveraging their great ideas—has also strengthened The Improve Group's evaluation practice and operations as an organization. Balancing short‐ and long‐term opportunities has helped the organization stay nimble and situate its...
Source: New Directions for Evaluation - December 11, 2019 Category: Universities & Medical Training Authors: Leah Goldstein Moses Tags: Research Article Source Type: research
Standing on the Shoulders of Giants: Applying Business Management Approaches to Independent Evaluation Consulting
AbstractIndependent evaluation consultants frequently discuss “how‐to” strategies to determine ways to start or improve their practices. Mostly this involves sharing advice on a range of topics such as how and when to set up a corporate structure, what accounting software to use, how to develop new business, and where to work. Such advice also should inc lude information about business theory that more broadly orients consultants to business planning. This movement, from the “how” to the “why,” is imperative for long‐term business success. This chapter introduces three widely accepted business books that co...
Source: New Directions for Evaluation - December 11, 2019 Category: Universities & Medical Training Authors: Matthew L. Feldmann Tags: Research Article Source Type: research
Growing and Nurturing Your Evaluation Business When Your Independent Consultancy Becomes an Employer
AbstractLessons learned from 19 years building an evaluation consulting business can inform other business owners. The Improve Group has grown from a one ‐woman consultancy to an employer of more than thirty people. Staying grounded in a mission and a clear set of values is a guiding principle that has guided and informed growth. Sharing power with staff—to operate democratically while also leveraging their great ideas—has also strengthened The Improve Group's evaluation practice and operations as an organization. Balancing short‐ and long‐term opportunities has helped the organization stay nimble and situate its...
Source: New Directions for Evaluation - December 11, 2019 Category: Universities & Medical Training Authors: Leah Goldstein Moses Tags: Research Article Source Type: research
Standing on the Shoulders of Giants: Applying Business Management Approaches to Independent Evaluation Consulting
AbstractIndependent evaluation consultants frequently discuss “how‐to” strategies to determine ways to start or improve their practices. Mostly this involves sharing advice on a range of topics such as how and when to set up a corporate structure, what accounting software to use, how to develop new business, and where to work. Such advice also should inc lude information about business theory that more broadly orients consultants to business planning. This movement, from the “how” to the “why,” is imperative for long‐term business success. This chapter introduces three widely accepted business books that co...
Source: New Directions for Evaluation - December 11, 2019 Category: Universities & Medical Training Authors: Matthew L. Feldmann Tags: Research Article Source Type: research
The Effect of Home Care for Stroke Patients and Education of Caregivers on the Caregiver Burden and Quality of Life.
This study results indicated that home care provided for stroke patients and education of caregivers decreased the caregiver burden and increased their quality of life.
PMID: 31819329 [PubMed - in process] (Source: Acta Clinica Croatica)
Source: Acta Clinica Croatica - December 11, 2019 Category: General Medicine Tags: Acta Clin Croat Source Type: research
The role of university Knowledge Transfer Offices: Not just commercialize research outputs!
This article focuses on the role of university KTO in supporting, facilitating or undertaking Third Mission community engagement activities. Drawing on data from the annual Higher Education Business and Community Interaction survey for the years 2007–2012, this paper empirically explores the relationship between a range of Third Mission activities by university KTO and performance of three key business-community services – provision of consultancy, provision of continuous professional development courses (CPD), and leasing of facilities and equipment (FE). It emerges that the routines of developing strategic plan and c...
Source: Technovation - December 4, 2019 Category: Science Source Type: research
Evaluation for learning and improvement at the right time: an example from the field.
This article describes a way of working where the program management team and an external evaluation consultancy collaboratively designed and implemented an utilisation-focused evaluation, informed by a developmental evaluation approach. Additionally, principles of knowledge translation were embedded in this process, thereby supporting the evaluation to translate knowledge into practice. The lessons learned were that combining external information and practice-based knowledge with local knowledge and experience is invaluable; it is useful to incorporate evaluative information from inception and for the duration of a progra...
Source: Rural and Remote Health - November 26, 2019 Category: Rural Health Tags: Rural Remote Health Source Type: research
[Gambling disorder and imputability: from the nosographic revision to an expanded forensic assessment].
Authors: Anselmi N, Montaldo S, Pomilla A
Abstract
The gambling disorder (GD in the DSM-5) is an example of how the evolution of research has contributed to the nosographic review of complex psychopathological conditions, such as behavioral addictions, likewise other personality pathologies. Recently, the scientific and doctrinal debate has also affected the controversial issue of imputability, to assess in what terms this diagnostic picture can acquire the value of "infirmity" such as to undermine the ability to understand and the will of a subject under evaluation. However, it is always necessary to tran...
Source: Rivista di Psichiatria - October 30, 2019 Category: Psychiatry Tags: Riv Psichiatr Source Type: research
