title: Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies

acronym: ARCS-Multi

summary:
The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors.

The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.

Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule).

Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.

design_allocation: Non-Randomized

ipd_sharing_description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Italy
United States
Switzerland
Netherlands
France
Singapore
Belgium
Australia
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Washington University School of Medicine

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Clínic i Provincial de Barcelona


design_allocation: Randomized

intervention_type: Drug

status: Completed

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Janssen Research & Development, LLC

enrollment_type: Actual

primary_purpose: Treatment

location_country:
France
Poland
Hungary
Spain
United States

acronym: DARZALEX

study_completion_date_type: Actual

type: EudraCT Number

type: Other Identifier

source: euctr

title: A Phase 1b/2, Open-Label, Randomized Study of Daratumumab Administered in Combination With Atezolizumab Compared With Atezolizumab Alone in Subjects With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer

summary: The purpose of the study is to compare the overall response rate (ORR) in non-small cell lung cancer (NSCLC) participants treated with daratumumab in combination with atezolizumab versus atezolizumab alone.

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: result

ReferenceCitation: Zinman B, Aroda VR, Buse JB, Cariou B, Harris SB, Hoff ST, Pedersen KB, Tarp-Johansen MJ, Araki E; PIONEER 8 Investigators. Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. Diabetes Care. 2019 Dec;42(12):2262-2271. doi: 10.2337/dc19-0898. Epub 2019 Sep 17.

family: Zinman

full_name: Bernard Zinman

given: Bernard

sequence: first

family: Aroda

full_name: Vanita R. Aroda

given: Vanita R.

sequence: additional

family: Buse

full_name: John B. Buse

given: John B.

family: Cariou

full_name: Bertrand Cariou

given: Bertrand

family: Harris

full_name: Stewart B. Harris

given: Stewart B.

family: Hoff

full_name: Søren Tetens Hoff

given: Søren Tetens

family: Pedersen

full_name: Karen Boje Pedersen

given: Karen Boje

family: Tarp-Johansen

full_name: Mads Jeppe Tarp-Johansen

given: Mads Jeppe

family: Araki

full_name: Eiichi Araki

given: Eiichi

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetes Care

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via OAI-PMH title and first author match)

host_type: repository

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

ReferenceType: derived

ReferenceCitation: Pratley RE, Crowley MJ, Gislum M, Hertz CL, Jensen TB, Khunti K, Mosenzon O, Buse JB. Oral Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Diabetes Ther. 2021 Apr;12(4):1099-1116. doi: 10.1007/s13300-020-00994-9. Epub 2021 Mar 4.

family: Pratley

full_name: Richard E. Pratley

given: Richard E.

family: Crowley

full_name: Matthew J. Crowley

given: Matthew J.

family: Gislum

full_name: Mette Gislum

given: Mette

family: Hertz

full_name: Christin L. Hertz

given: Christin L.

family: Jensen

full_name: Thomas B. Jensen

given: Thomas B.

family: Khunti

full_name: Kamlesh Khunti

given: Kamlesh

family: Mosenzon

full_name: Ofri Mosenzon

given: Ofri

journal_name: Diabetes Therapy

oa_colors: green gold

title: Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses

ReferenceCitation: Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

repositories:
PubMed Central
cronfa.swan.ac.uk
localhost

repositories_institution:
Swansea University - Cronfa
University of Toronto - TSpace

ReferenceCitation: Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13. Review.

name: AdventHealth Translational Research Institute Orlando Florida USA

name: Diabetes Centre Bochum‐Hattingen, St Josef‐HospitalRuhr‐University Bochum Bochum Germany

title: Efficacy, safety and cardiovascular outcomes of once‐daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme

ReferenceCitation: Husain M, Bain SC, Jeppesen OK, Lingvay I, Sørrig R, Treppendahl MB, Vilsbøll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

name: Ted Rogers Centre for Heart ResearchToronto General Hospital Research Institute Toronto Canada

name: Swansea University Medical School, Diabetes Research Unit Cymru Swansea UK

name: UT Southwestern Medical Center, Internal Medicine and Population and Data Sciences Dallas Texas

name: Steno Diabetes Center CopenhagenGentofte Hospital, University of Copenhagen Copenhagen Denmark

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
India
Mexico
France
Japan
Greece
Poland
Puerto Rico
Russian Federation
United States
Canada

title: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)

summary: This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated with insulin. All subjects should continue their pre-trial insulin therapy (basal, basal-bolus or premixed regimen including combinations of soluble insulins) throughout the trial. Subjects treated with metformin in addition to insulin treatment must continue their metformin treatment throughout the entire trial.


ReferenceCitation: Paik PK, Felip E, Veillon R, Sakai H, Cortot AB, Garassino MC, Mazieres J, Viteri S, Senellart H, Van Meerbeeck J, Raskin J, Reinmuth N, Conte P, Kowalski D, Cho BC, Patel JD, Horn L, Griesinger F, Han JY, Kim YC, Chang GC, Tsai CL, Yang JC, Chen YM, Smit EF, van der Wekken AJ, Kato T, Juraeva D, Stroh C, Bruns R, Straub J, Johne A, Scheele J, Heymach JV, Le X. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med. 2020 Sep 3;383(10):931-943. doi: 10.1056/NEJMoa2004407. Epub 2020 May 29.

name: From Memorial Sloan Kettering Cancer Center, New York (P.K.P.); the Oncology Department, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (E.F.), and Dr. Rosell Oncology Institute, Dexeus University Hospital, Quirónsalud Group (S.V.), Barcelona; Centre Hospitaliere Universitaire (CHU) Bordeaux, Service des Maladies Respiratoires, Bordeaux (R.V.), Université de Lille, CHU Lille, Thoracic Oncology Department, Centre National de la Recherche Scientifique, INSERM, Institut Pasteur de...

family: Paik

full_name: Paul K. Paik

given: Paul K.

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Veillon

full_name: Remi Veillon

given: Remi

family: Sakai

full_name: Hiroshi Sakai

given: Hiroshi

family: Cortot

full_name: Alexis B. Cortot

given: Alexis B.

family: Garassino

full_name: Marina C. Garassino

given: Marina C.

family: Mazieres

full_name: Julien Mazieres

given: Julien

family: Viteri

full_name: Santiago Viteri

given: Santiago

family: Senellart

full_name: Helene Senellart

given: Helene

family: Van Meerbeeck

full_name: Jan Van Meerbeeck

given: Jan

family: Raskin

full_name: Jo Raskin

given: Jo

family: Reinmuth

full_name: Niels Reinmuth

given: Niels

family: Conte

full_name: Pierfranco Conte

given: Pierfranco

family: Kowalski

full_name: Dariusz Kowalski

given: Dariusz

family: Cho

full_name: Byoung Chul Cho

given: Byoung Chul

family: Patel

full_name: Jyoti D. Patel

given: Jyoti D.

family: Horn

full_name: Leora Horn

given: Leora

family: Griesinger

full_name: Frank Griesinger

given: Frank

family: Han

full_name: Ji-Youn Han

given: Ji-Youn

family: Kim

full_name: Young-Chul Kim

given: Young-Chul

family: Chang

full_name: Gee-Chen Chang

given: Gee-Chen

family: Tsai

full_name: Chen-Liang Tsai

given: Chen-Liang

family: Yang

full_name: James C.-H. Yang

given: James C.-H.

family: Chen

full_name: Yuh-Min Chen

given: Yuh-Min

family: Smit

full_name: Egbert F. Smit

given: Egbert F.

title: Tepotinib in Non–Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
Germany
France
Japan
Poland
Israel
Belgium
China
United States
Korea, Republic of
Taiwan

location_facility: Regional Cancer Care Associates East Brunswick

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: Universitair Medisch Centrum Groningen (UMCG) - Parent

location_facility: The Affiliated Cancer Hospital of Xinjiang Medical university

location_facility: Seconda Università degli Studi di Napoli

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: Memorial Sloan Kettering Cancer Center, West Harrison Regional Outpatient Pavilion

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Wenatchee Valley Hospital & Clinics - ATTN: Jay Johnson

location_facility: Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska

location_facility: Chonnam National University Hwasun Hospital

location_facility: Kyungpook National University Medical Center

location_facility: LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Inselspital - Universitaetsspital Bern - Klinik und Poliklinik für Medizinische Onkologie

location_facility: NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Universitaetsspital Zuerich - Klinik fuer Onkologie

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Hospital General Universitario Santa Lucia

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: Hackensack University Medical Center PARTNER

title: A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION)

summary: This study will look at how effective the study drug (tepotinib) is at stopping the growth and spread of lung cancer. This study will also measure a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug.


intervention_type: Biological

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

primary_purpose: Other

location_country:
United States
Chile
Germany
France
Bulgaria
Czechia
Poland
Argentina
Australia
Russian Federation
Spain
Turkey
Canada
United Kingdom
Ukraine

acronym: MELTEMI

ipd_sharing: Yes

title: A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)

summary: The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).


title: A Biomarker-Directed Phase 2 Trial of SY-1425, a Selective Retinoic Acid Receptor Alpha Agonist, in Adult Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

summary: The purpose of this study is to determine the activity of SY-1425 in relapsed/refractory acute myeloid leukemia (AML) patients (SY-1425 administered as a monotherapy or in combination with azacitidine), relapsed/refractory higher-risk myelodysplastic syndrome (MDS) patients (SY-1425 administered as a monotherapy or in combination with daratumumab), newly diagnosed treatment naïve AML patients who are unlikely to tolerate standard intensive chemotherapy (SY-1425 administered as a monotherapy or in combination with azacitidine), or lower-risk myelodysplastic syndrome (MDS) patients (SY-1425 administered as a monotherapy).

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Syros Pharmaceuticals

location_country:
United States
France

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot

location_facility: Nice Hospital, Archet Hospital 1 Clinical Hematology Service

location_facility: Hôpital Haut Leveque, Centre Francois Magendie

location_facility: Centre Hospitalier Universitiaire Hopital Avicenne

status_simplified: Ongoing


title: A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease

acronym: ExpeditionPRO

summary: The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).

status: Terminated

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
Sweden
Finland
France
Japan
Poland
Puerto Rico
Spain
Germany
United Kingdom
Canada
Taiwan

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Univ of Texas Health Science Center at San Antonio

location_facility: New England Institute for Clinical Research

location_facility: Johns Hopkins University School of Medicine

location_facility: Healthy Perspectives Innovative Mental Health Services, PL

location_facility: Dean Foundation for Health Research and Education

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Metrolina Neurological Research Institute

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Instituto de Neurologia Dra. Ivonne Fraga

location_facility: Premiere Research Institute at Palm Beach Neurology

location_facility: University of Texas Health Services Center - Houston

location_facility: Northeastern Pennsylvania Memory & Alzheimer's Center

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Advanced Memory Research Institute of New Jersey

status_simplified: Unknown


title: A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma

summary: For Groups 1 to 4, the primary objective of this study is to estimate the clinical benefit of cemiplimab monotherapy for patients with: metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC. For Group 6, the primary objective is to provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced. Clinical benefit is measured by overall response rate (ORR) according to central review in each group.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Rischin D, Khushalani NI, Schmults CD, Guminski A, Chang ALS, Lewis KD, Lim AM, Hernandez-Aya L, Hughes BGM, Schadendorf D, Hauschild A, Thai AA, Stankevich E, Booth J, Yoo SY, Li S, Chen Z, Okoye E, Chen CI, Mastey V, Sasane M, Lowy I, Fury MG, Migden MR. Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis. J Immunother Cancer. 2021 Aug;9(8). pii: e002757. doi: 10.1136/jitc-2021-002757.

family: Rischin

full_name: Danny Rischin

given: Danny

family: Khushalani

full_name: Nikhil I Khushalani

given: Nikhil I

family: Schmults

full_name: Chrysalyne D Schmults

given: Chrysalyne D

family: Guminski

full_name: Alexander Guminski

given: Alexander

full_name: Anne Lynn S Chang

given: Anne Lynn S

family: Lewis

full_name: Karl D Lewis

given: Karl D

family: Lim

full_name: Annette M Lim

given: Annette M

family: Hernandez-Aya

full_name: Leonel Hernandez-Aya

given: Leonel

family: Hughes

full_name: Brett G M Hughes

given: Brett G M

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Hauschild

full_name: Axel Hauschild

given: Axel

family: Thai

full_name: Alesha A Thai

given: Alesha A

family: Stankevich

full_name: Elizabeth Stankevich

given: Elizabeth

family: Booth

full_name: Jocelyn Booth

given: Jocelyn

family: Yoo

full_name: Suk-Young Yoo

given: Suk-Young

family: Li

full_name: Siyu Li

given: Siyu

full_name: Zhen Chen

given: Zhen

family: Okoye

full_name: Emmanuel Okoye

given: Emmanuel

full_name: Chieh-I Chen

given: Chieh-I

family: Mastey

full_name: Vera Mastey

given: Vera

family: Sasane

full_name: Medha Sasane

given: Medha

family: Lowy

full_name: Israel Lowy

given: Israel

family: Fury

full_name: Matthew G Fury

given: Matthew G

repository_normalized: University of Melbourne - Minerva Access

ReferenceCitation: Paccaly AJ, Migden MR, Papadopoulos KP, Yang F, Davis JD, Rippley RK, Lowy I, Fury MG, Stankevich E, Rischin D. Fixed Dose of Cemiplimab in Patients with Advanced Malignancies Based on Population Pharmacokinetic Analysis. Adv Ther. 2021 May;38(5):2365-2378. doi: 10.1007/s12325-021-01638-5. Epub 2021 Mar 25.

ReferenceCitation: Rischin D, Migden MR, Lim AM, Schmults CD, Khushalani NI, Hughes BGM, Schadendorf D, Dunn LA, Hernandez-Aya L, Chang ALS, Modi B, Hauschild A, Ulrich C, Eigentler T, Stein B, Pavlick AC, Geiger JL, Gutzmer R, Alam M, Okoye E, Mathias M, Jankovic V, Stankevich E, Booth J, Li S, Lowy I, Fury MG, Guminski A. Phase 2 study of cemiplimab in patients with metastatic cutaneous squamous cell carcinoma: primary analysis of fixed-dosing, long-term outcome of weight-based dosing. J Immunother Cancer. 2020 Jun;8(1). pii: e000775. doi: 10.1136/jitc-2020-000775.

ReferenceCitation: Migden MR, Khushalani NI, Chang ALS, Lewis KD, Schmults CD, Hernandez-Aya L, Meier F, Schadendorf D, Guminski A, Hauschild A, Wong DJ, Daniels GA, Berking C, Jankovic V, Stankevich E, Booth J, Li S, Weinreich DM, Yancopoulos GD, Lowy I, Fury MG, Rischin D. Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. Lancet Oncol. 2020 Feb;21(2):294-305. doi: 10.1016/S1470-2045(19)30728-4. Epub 2020 Jan 14.

ReferenceCitation: Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.

name: From the Departments of Dermatology and Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston (M.R.M.), and South Texas Accelerated Research Therapeutics (START), San Antonio (K.P.P.) — both in Texas; the Department of Medical Oncology, Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, VIC (D.R., A.A.T.), the Department of Medical Oncology, Royal North Shore Hospital, St. Leonards, VIC (A.G.), the Department of Medical Oncology, Sir Charles Gairdner Hospital,...

repository_institution: The University of Queensland - Queensland's institutional digital repository

repository_institution: The University of Arizona - UA Campus Repository

location_country:
Italy
Brazil
Germany
France
Greece
Australia
New Zealand
Spain
United States

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

location_facility: Fundação Antônio Prudente - AC Camargo Câncer Center

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Andreas Sygros Hosptial-University of Athen

location_facility: Instituto do Cancer do Estado de São Paulo ICESP

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: St. Luke's Hematology Oncology Specialists

location_facility: Fundação São Francisco Xavier-Hospital Márcio Cunha

location_facility: Dermatology and Laser Center of Charleston

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Fundacion Instituto Valenciano de Oncología

location_facility: Fondazione Policlinico Universitario A Gemelli


title: Efficacy, Safety and Immunogenicity of GSK Biologicals' HZ/su Vaccine GSK1437173A in a Phase IIIb, Open-label, Long-term Follow-up Study (ZOE-LTFU) of Studies 110390/113077 (ZOSTER-006/022) and Assessment of Additional Doses in Older Adults

summary: The purpose of this study is a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1 or 2 additional doses in two subgroups of older adults.

primary_purpose: Prevention

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Brazil
United States
Sweden
Hong Kong
Mexico
Germany
Finland
France
Czechia
Japan
Australia
Spain
Estonia
Canada
United Kingdom
Korea, Republic of
Taiwan


title: An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments

acronym: ASCENT

summary: The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.

ReferenceType: background

ReferenceCitation: Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi: 10.1056/NEJMoa1814213.

ReferenceCitation: Bardia A, Tolaney SM, Punie K, Loirat D, Oliveira M, Kalinsky K, Zelnak A, Aftimos P, Dalenc F, Sardesai S, Hamilton E, Sharma P, Recalde S, Gil EC, Traina T, O'Shaughnessy J, Cortes J, Tsai M, Vahdat L, Diéras V, Carey LA, Rugo HS, Goldenberg DM, Hong Q, Olivo M, Itri LM, Hurvitz SA. Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. Ann Oncol. 2021 Sep;32(9):1148-1156. doi: 10.1016/j.annonc.2021.06.002. Epub 2021 Jun 8.

family: Bardia

full_name: A. Bardia

given: A.

family: Tolaney

full_name: S.M. Tolaney

family: Punie

full_name: K. Punie

given: K.

family: Loirat

full_name: D. Loirat

given: D.

family: Oliveira

full_name: M. Oliveira

given: M.

family: Kalinsky

full_name: K. Kalinsky

family: Zelnak

full_name: A. Zelnak

family: Aftimos

full_name: P. Aftimos

given: P.

family: Dalenc

full_name: F. Dalenc

given: F.

family: Sardesai

full_name: S. Sardesai

given: S.

family: Hamilton

full_name: E. Hamilton

given: E.

family: Sharma

full_name: P. Sharma

family: Recalde

full_name: S. Recalde

family: Gil

full_name: E.C. Gil

family: Traina

full_name: T. Traina

given: T.

family: O’Shaughnessy

full_name: J. O’Shaughnessy

given: J.

family: Cortes

full_name: J. Cortes

family: Tsai

full_name: M. Tsai

family: Vahdat

full_name: L. Vahdat

given: L.

family: Diéras

full_name: V. Diéras

given: V.

family: Carey

full_name: L.A. Carey

family: Rugo

full_name: H.S. Rugo

family: Goldenberg

full_name: D.M. Goldenberg

family: Hong

full_name: Q. Hong

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

ReferenceCitation: Dieras V, Weaver R, Tolaney SM, et al. 2020 SABCS PD13-07. Subgroup analysis of patients with brain metastases from the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.

ReferenceCitation: Rugo HS, Tolaney SM, Loirat D, et al. 2020 SABCS PS11-09. Impact of UGT1A1 status on the safety profile of sacituzumab govitecan in the phase 3 ASCENT study in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.

ReferenceCitation: Bardia A, Tolaney SM, Loirat D, et al. ASCENT: A randomized phase III study of sacituzumab govitecan (SG) vs treatment of physician's choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC). Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

ReferenceCitation: Bardia A, Rugo RS, Horne H, et al. A phase III, randomized trial of sacituzumab govitecan (IMMU-132) vs treatment of physician choice (TPC) for metastatic triple-negative breast cancer (mTNBC). Cancer Res. 2018;78 (4 Supplement): OT2-07-05

ReferenceCitation: Bardia A, Hurvitz SA, Rugo HS, Brufsky A, Cortes J, Loibl S, Piccart M, Cowden J, Spears P, Carey LA. A plain language summary of the ASCENT study: Sacituzumab Govitecan for metastatic triple-negative breast cancer. Future Oncol. 2021 Oct 1;17(30):3911-3924. doi: 10.2217/fon-2021-0868. Epub 2021 Sep 1.

name: Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA

name: University of California, Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA

name: University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA

name: Magee-Women’s Hospital and the Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA

name: International Breast Cancer Center (IBCC), Quiron Group, Barcelona, Spain

name: Department of Medicine and Research, Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus, Frankfurt, Germany

name: Institut Jules Bordet, Université libre de Bruxelles, Brussels, Belgium

name: Department of Medicine – Division of Hematology/Oncology, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA

ReferenceCitation: Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Sardesai SD, Kalinsky K, Zelnak AB, Weaver R, Traina T, Dalenc F, Aftimos P, Lynce F, Diab S, Cortés J, O'Shaughnessy J, Diéras V, Ferrario C, Schmid P, Carey LA, Gianni L, Piccart MJ, Loibl S, Goldenberg DM, Hong Q, Olivo MS, Itri LM, Rugo HS; ASCENT Clinical Trial Investigators. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021 Apr 22;384(16):1529-1541. doi: 10.1056/NEJMoa2028485.

name: From the Division of Medical Oncology, Massachusetts General Hospital Cancer Center (A. Bardia), and the Department of Medical Oncology, Dana–Farber Cancer Institute (S.M.T.) — both in Boston; the University of California, Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); the Medical Oncology Department and the Department of Drug Development and Innovation, Institut Curie, Paris (D.L.), Institut Claudius Regaud, Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse (F.D.),...

title: Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer

ReferenceCitation: McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671. Review.

journal_name: Current Opinion in Obstetrics & Gynecology

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Seligson JM, Patron AM, Berger MJ, Harvey RD, Seligson ND. Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Ann Pharmacother. 2021 Jul;55(7):921-931. doi: 10.1177/1060028020966548. Epub 2020 Oct 17. Review.

name: Nova Southeastern University, Clearwater, FL, USA

name: University of Florida, Jacksonville, FL, USA

name: The Ohio State University, Columbus, OH, USA

name: Emory University School of Medicine, Atlanta, GA, USA

name: Nemours Children’s Specialty Care, Jacksonville, FL, USA

location_country:
United States
Germany
France
Belgium
Spain
Canada
United Kingdom

location_facility: Rocky Mountain Cancer Centers, 4715 Arapahoe Ave

location_facility: Rocky Mountain Cancer Centers, 1700 South Potomac Street

location_facility: Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400

location_facility: University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street

location_facility: The County Hospital, Wye Valley NHS Trust

location_facility: Souther Cancer Center, 3719 Dauphin St., 5 Floor

location_facility: Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard

location_facility: The Royal Surrey County Hospital NHS Foundation Trust

location_facility: University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion

location_facility: Southern Cancer Center, 29653 Anchor Cross Blvd

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: Rocky Mountain Cancer Centers, 8820 Huron Street

location_facility: Nebraska Cancer Specialists - Midwest Cancer Center - Papillion

location_facility: Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing

location_facility: Sarah Cannon Cancer Institute/Tennessee Oncology

location_facility: Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital

location_facility: UPMC Hillman Cancer Center Upper Saint Clair

location_facility: Hospital Quirón Barcelona, Plaza Alfonso Comín 5

location_facility: UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard

location_facility: UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion

location_facility: Institut für Versorgungsforschung in der Onkologie

location_facility: The Arden Cancer Centre- University Hospital Coventry

location_facility: Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive

location_facility: Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Florida Cancer Specialists & Research Institute - 3730 7th Terrace

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Florida Cancer Specialists & Research Institute - 325 Clyde Morris

location_facility: Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level

location_facility: Southern Cancer Center, 3 Mobile Infirmary Circle

location_facility: Washington University School of Medicine in St. Louis

location_facility: Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203

location_facility: University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd

location_facility: Florida Cancer Specialists & Research Institute, 560 Jackson St

location_facility: MidAmerica Division Inc. c/o Menorah Medical Center

location_facility: Florida Cancer Specialists & Research Institute, 1400 US highway 441 N

location_facility: UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza

location_facility: Florida Cancer Specialists & Research Institute1309 N Flagler Dr

location_facility: Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd

location_facility: Praxis für Hämatologie und Internistische Onkologie

location_facility: Praxis für interdisziplinäre Onkologie & Hämatologie GbR

location_facility: West Cancer Center, 7945 Wolf River Blvd

location_facility: Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450

location_facility: Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100

location_facility: The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway

location_facility: UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200

location_facility: Florida Cancer Specialists & Research Institute, 100 Highland Avenue

location_facility: Rocky Mountain Cancer Centers, 1800 Williams St.

location_facility: Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01

location_facility: Cross Cancer Institute, 11560 University Avenue

location_facility: Tennessee Oncology - Chattanooga Oncology & Hematology Associates

location_facility: Texas Oncology- Medical City Dallas Building D

location_facility: Florida Cancer Specialists & Research Institute, 403 S. King Ave

location_facility: The Ohio State University Wexner Medical Center, 460 W 10th Ave

location_facility: County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinco Universaitario

location_facility: Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive

location_facility: Houston Methodist Hospital - 6565 Fannin St

location_facility: The Royal Free London NHS Foundation Trust - The Royal Free Hospital, Pond Street Oncology & Haematology Clinical Trials Unit Dept. of Academic Oncology

location_facility: University Cancer & Blood Center, 3320 Old Jefferson Rd

location_facility: Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B

location_facility: Virginia G. Piper Cancer Center at HonorHealth

location_facility: Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road

location_facility: Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway

location_facility: Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road

location_facility: Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210

location_facility: Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421

location_facility: Jewish General Hospital, 3755 Côte-Sainte-Catherine

location_facility: UPMC Hillman Cancer Center UPMC Passavant

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Florida Cancer Specialists & Research Institute, 765 Image Way

location_facility: Mass General - North Shore Cancer Center ( NSCC )

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court

location_facility: Baptist Health Medical Group Oncology, LLC

location_facility: Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin

location_facility: Nebraska Cancer Specialists- Midwest Cancer Center- Papillion

location_facility: The Ohio State University Wexner Medical Center, 1145 Olentangy River Road

location_facility: Florida Cancer Specialists & Research Institute, 1630 SE 18th ST

location_facility: UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road

location_facility: Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400

location_facility: Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90

location_facility: Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North

location_facility: Allegheny-Singer Research Institute, 320 East North Avenue

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16

location_facility: Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Rocky Mountain Cancer Centers, 22 West Dry Creek Circle

location_facility: Nebraska Cancer Specialists - Midwest Cancer Center - Paillion

location_facility: Florida Cancer Specialists & Research Institute, 70 W Gore Street

location_facility: University of Chicago Medical Center 5841 S. Maryland Ave

location_facility: Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000

location_facility: Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350

location_facility: Georgetown Lombardi Comprehensive Cancer Center

location_facility: UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320

location_facility: Florida Cancer Specialists & Research Institute, 4100 Waterman Way


publications_result: Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

ReferenceCitation: Garcia-Manero G, Fenaux P, Al-Kali A, Baer MR, Sekeres MA, Roboz GJ, Gaidano G, Scott BL, Greenberg P, Platzbecker U, Steensma DP, Kambhampati S, Kreuzer KA, Godley LA, Atallah E, Collins R Jr, Kantarjian H, Jabbour E, Wilhelm FE, Azarnia N, Silverman LR; ONTIME study investigators. Rigosertib versus best supportive care for patients with high-risk myelodysplastic syndromes after failure of hypomethylating drugs (ONTIME): a randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Apr;17(4):496-508. doi: 10.1016/S1470-2045(16)00009-7. Epub 2016 Mar 9.

family: Garcia-Manero

full_name: Guillermo Garcia-Manero

given: Guillermo

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

family: Al-Kali

full_name: Aref Al-Kali

given: Aref

family: Baer

full_name: Maria R Baer

given: Maria R

family: Sekeres

full_name: Mikkael A Sekeres

given: Mikkael A

family: Roboz

full_name: Gail J Roboz

given: Gail J

family: Gaidano

full_name: Gianluca Gaidano

given: Gianluca

family: Scott

full_name: Bart L Scott

given: Bart L

family: Greenberg

full_name: Peter Greenberg

given: Peter

family: Platzbecker

full_name: Uwe Platzbecker

given: Uwe

family: Steensma

full_name: David P Steensma

given: David P

family: Kambhampati

full_name: Suman Kambhampati

given: Suman

family: Kreuzer

full_name: Karl-Anton Kreuzer

given: Karl-Anton

family: Godley

full_name: Lucy A Godley

given: Lucy A

family: Atallah

full_name: Ehab Atallah

given: Ehab

family: Collins

full_name: Robert Collins

given: Robert

suffix: Jr

family: Kantarjian

full_name: Hagop Kantarjian

given: Hagop

family: Jabbour

full_name: Elias Jabbour

given: Elias

family: Wilhelm

full_name: Francois E Wilhelm

given: Francois E

family: Azarnia

full_name: Nozar Azarnia

given: Nozar

family: Silverman

full_name: Lewis R Silverman

given: Lewis R

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Athuluri-Divakar SK, Vasquez-Del Carpio R, Dutta K, Baker SJ, Cosenza SC, Basu I, Gupta YK, Reddy MV, Ueno L, Hart JR, Vogt PK, Mulholland D, Guha C, Aggarwal AK, Reddy EP. A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling. Cell. 2016 Apr 21;165(3):643-55. doi: 10.1016/j.cell.2016.03.045.

ReferenceCitation: Navada SC, Silverman LR. The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes. Expert Rev Anticancer Ther. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Epub 2016 Jul 15. Review.

family: Navada

full_name: Shyamala C. Navada

given: Shyamala C.

location_country:
Australia
Belgium
Russian Federation
India
Croatia
France
Japan
Poland
Canada
Sweden
Switzerland
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Austria
Czechia
Israel
Spain
Estonia

location_facility: Tokai Central Hospital of the Mutual Aid Association of Public School Teachers

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Somogy County Kaposi Mór Teaching Hospital

location_facility: Albert Einstein Medical Center, Cancer Center

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: FSBI "Russian Scientific Research Hematology and Tranfusiology Institute of the Federal Biomedical Agency"

location_facility: Independent Public Health Care Facility of the Ministry of Internal Affairs with Warmia and Mazury Oncology Centre in Olsztyn

location_facility: Cittá della Salute e della Scienza di Torino

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Hospital Duran i Reynals - Instituto Catalán de Oncología

location_facility: Hospital of the University of Pennsylvania

location_facility: University Hospital Leuven, Campus Gasthuisberg

location_facility: Institute Of Hematology And Transfusion Medicine

location_facility: University Hospital and University of Bern; Inselspital Bern

location_facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital

location_facility: Greenville Health System (GHS) Cancer Institute

location_facility: A.O.U. Pisana, Divisione di Ematologia - University Hospital of Pisa

location_facility: Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Sahyadri Clinical Research and Development Center

location_facility: Ospedale S. Eugenio - S. Eugenio Hospital

location_facility: University Hospital Ostrava, Department of Hematooncology

location_facility: University of Wisconsin Clinical Science Center

location_facility: Independent Public University Hospital No. 1 in Wroclaw, Department of Hematology, Blood Cancers and Bone Marrow

location_facility: Adelaide and Meath Hospital, Incorporating the National Children's Hospital

location_facility: University of Pécs 1st Department of Internal Medicine

location_facility: Skåne University Hospital, Department of Hematology

location_facility: Institute of Hematology and Blood Transfusion

location_facility: Loyola University Chicago at Loyola University Medical Center

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Mid Florida Hematology and Oncology Centers

location_facility: King's College Hospital NHS Foundation Trust

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: St Bartholomew's Hospital, Barts Health NHS Trust

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Independent Public Healthcare Facility University Hospital in Cracow, Clinical Department of Hematology

location_facility: Klinički bolnicki centar Sestre milosrdnice

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Niigata University Medical and Dental Hospital

location_facility: State Budgetary Healthcare Institution of Moscow City

location_facility: State Autonomous Healthcare Institution of Kemerovo region "Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev",

location_facility: University of Minnesota Physicians Bone Marrow Transplant Clinic

location_facility: Ludwik Rydygier Provinicial Hospital in Suwalki, Department of Clinical Oncology and Hematology

title: A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent

summary: The study's primary objective [in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.


title: A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)

summary: The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.

status: Withdrawn

lead_sponsor: Bristol-Myers Squibb

location_country: Canada France


ReferenceCitation: Brightling CE, Gaga M, Inoue H, Li J, Maspero J, Wenzel S, Maitra S, Lawrence D, Brockhaus F, Lehmann T, Brindicci C, Knorr B, Bleecker ER. Effectiveness of fevipiprant in reducing exacerbations in patients with severe asthma (LUSTER-1 and LUSTER-2): two phase 3 randomised controlled trials. Lancet Respir Med. 2021 Jan;9(1):43-56. doi: 10.1016/S2213-2600(20)30412-4. Epub 2020 Sep 24.

family: Brightling

full_name: Christopher E Brightling

given: Christopher E

family: Gaga

full_name: Mina Gaga

given: Mina

family: Inoue

full_name: Hiromasa Inoue

given: Hiromasa

family: Li

full_name: Jing Li

given: Jing

family: Maspero

full_name: Jorge Maspero

given: Jorge

family: Wenzel

full_name: Sally Wenzel

given: Sally

family: Maitra

full_name: Samopriyo Maitra

given: Samopriyo

family: Lawrence

full_name: David Lawrence

given: David

family: Brockhaus

full_name: Florian Brockhaus

given: Florian

family: Lehmann

full_name: Thomas Lehmann

given: Thomas

family: Brindicci

full_name: Caterina Brindicci

given: Caterina

family: Knorr

full_name: Barbara Knorr

given: Barbara

family: Bleecker

full_name: Eugene R Bleecker

given: Eugene R

journal_name: The Lancet Respiratory Medicine

lead_sponsor: Novartis Pharmaceuticals

location_country:
Guatemala
Finland
Greece
Romania
Australia
Belgium
Denmark
Iceland
France
Poland
Lithuania
Argentina
Switzerland
Vietnam
Philippines
Singapore
Hungary
Ireland
China
Germany
United States
United Kingdom
Austria
Brazil
Spain
Estonia
Latvia

title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.

summary:
This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:

patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)
patients with inadequately controlled severe asthma (overall study population)

Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).


title: A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)

acronym: CheckMate 451

summary: In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

ReferenceCitation: Owonikoko TK, Park K, Govindan R, Ready N, Reck M, Peters S, Dakhil SR, Navarro A, Rodríguez-Cid J, Schenker M, Lee JS, Gutierrez V, Percent I, Morgensztern D, Barrios CH, Greillier L, Baka S, Patel M, Lin WH, Selvaggi G, Baudelet C, Baden J, Pandya D, Doshi P, Kim HR. Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451. J Clin Oncol. 2021 Apr 20;39(12):1349-1359. doi: 10.1200/JCO.20.02212. Epub 2021 Mar 8.

name: Winship Cancer Institute of Emory University, Atlanta, GA

family: Owonikoko

full_name: Taofeek K. Owonikoko

given: Taofeek K.

name: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

family: Park

full_name: Keunchil Park

given: Keunchil

name: Alvin J Siteman Cancer Center at Washington University School of Medicine, St Louis, MO

family: Govindan

full_name: Ramaswamy Govindan

given: Ramaswamy

name: Duke University Medical Center, Durham, NC

family: Ready

full_name: Neal Ready

given: Neal

name: Department of Thoracic Oncology, Airway Research Center North, German Center for Lung Research, LungClinic, Grosshansdorf, Germany

family: Reck

full_name: Martin Reck

given: Martin

name: Oncology Department, Lausanne University Hospital, Lausanne, Switzerland

family: Peters

full_name: Solange Peters

given: Solange

family: Dakhil

full_name: Shaker R. Dakhil

given: Shaker R.

name: Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain

family: Navarro

full_name: Alejandro Navarro

given: Alejandro

name: Centro Oncológico, Médica Sur—Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico

family: Rodríguez-Cid

full_name: Jerónimo Rodríguez-Cid

given: Jerónimo

name: Centrul de Oncologie Sf Nectarie, Craiova, Romania

family: Schenker

full_name: Michael Schenker

given: Michael

name: Seoul National University Bundang Hospital, Seongnam, South Korea

family: Lee

full_name: Jong-Seok Lee

given: Jong-Seok

name: Hospital Regional Universitario de Málaga, Málaga, Spain

family: Gutierrez

full_name: Vanesa Gutierrez

given: Vanesa

name: Florida Cancer Specialists, Punta Gorda, FL

family: Percent

full_name: Ivor Percent

given: Ivor

family: Morgensztern

full_name: Daniel Morgensztern

given: Daniel

name: Oncology Research Center, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, Brazil

family: Barrios

full_name: Carlos H. Barrios

given: Carlos H.

name: Aix Marseille Univ, APHM, INSERM, CNRS, CRCM, Hôpital Nord, Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille, France

family: Greillier

full_name: Laurent Greillier

given: Laurent

name: Interbalkan European Medical Center, Thessaloniki, Greece

family: Baka

full_name: Sofia Baka

given: Sofia

name: Cancer Specialists of North Florida, Jacksonville, FL

family: Patel

full_name: Miten Patel

given: Miten

family: Lin

full_name: Wen Hong Lin

given: Wen Hong

family: Selvaggi

full_name: Giovanni Selvaggi

given: Giovanni

family: Baudelet

full_name: Christine Baudelet

given: Christine

family: Baden

full_name: Jonathan Baden

given: Jonathan

family: Pandya

full_name: Dimple Pandya

name: Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea

publisher: American Society of Clinical Oncology (ASCO)

location_country:
Peru
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

location_facility: University of Kansas Clinical Research Center

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: General Oncology Hospital of Kifissia Agioi Anargyroi


ReferenceCitation: Salloway S, Chalkias S, Barkhof F, Burkett P, Barakos J, Purcell D, Suhy J, Forrestal F, Tian Y, Umans K, Wang G, Singhal P, Budd Haeberlein S, Smirnakis K. Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease. JAMA Neurol. 2021 Nov 22. doi: 10.1001/jamaneurol.2021.4161. [Epub ahead of print]

name: Warren Alpert Medical School, Brown University, Providence, Rhode Island

family: Salloway

full_name: Stephen Salloway

given: Stephen

family: Chalkias

full_name: Spyros Chalkias

given: Spyros

name: Institutes of Healthcare Engineering and Neurology, University College London, London, United Kingdom

name: Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, the Netherlands

family: Barkhof

full_name: Frederik Barkhof

given: Frederik

family: Burkett

full_name: Patrick Burkett

given: Patrick

name: California Pacific Medical Center, San Francisco

family: Barakos

full_name: Jerome Barakos

given: Jerome

family: Purcell

full_name: Derk Purcell

given: Derk

family: Suhy

full_name: Joyce Suhy

given: Joyce

family: Forrestal

full_name: Fiona Forrestal

given: Fiona

family: Tian

full_name: Ying Tian

given: Ying

family: Umans

full_name: Kimberly Umans

given: Kimberly

family: Wang

full_name: Guanfang Wang

given: Guanfang

family: Singhal

full_name: Priya Singhal

given: Priya

family: Budd Haeberlein

full_name: Samantha Budd Haeberlein

given: Samantha

family: Smirnakis

full_name: Karen Smirnakis

given: Karen

journal_name: JAMA Neurology

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Biogen

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
Germany
Finland
France
Japan
Poland
Belgium
Spain
Canada

acronym: EMERGE

location_facility: Institut fuer Regenerative Medizin (IREM) der Universitaet Zuerich, Zentrum fuer Praevention und Demenztherapie

location_facility: Associated Neurologists of Southern Connecticut, PC

location_facility: NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.

location_facility: True North Clinical Research Kentville, Inc

location_facility: Clinical Neuroscience Research Association, Inc

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

location_facility: Centrum Diagnostyczno - Terapeutyczne "MEDICUS" Sp.z o.o.

location_facility: University of California San Diego Medical Center

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Emory University Cognitive Neurology Clinic & ADRC

location_facility: Schwerpunktpraxis fuer Neurologie, Psychiatrie und Klinische Studien

location_facility: Institut fuer Schlaganfall- und Demenzforschung (ISD)

location_facility: Universitären Psychiatrischen Kliniken Basel (UPK)

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre de Recherche Clinique du Gérontopôle - Cité de la Santé

location_facility: University of Utah Health Sciences Center

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Josephson, Wallack, Munshower Neurology, PC

location_facility: Medical Research Health and Education Foundation, Inc

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: SPZOZ Centralny Szpital Kliniczny UM w Lodzi

location_facility: Lehigh Center for Clinical Research, LLC

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: The Methodist Hospital Research Institute

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

location_facility: Centre Neurologique & de Réadaptation Fonctionnelle

location_facility: NZOZ "SENIOR" Poradnia Psychogeriatryczna

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit

location_facility: True North Clinical Research - Halifax Inc.

location_facility: Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

summary: The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].


title: A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

summary: This is a Phase 3, multicenter, open-label, 3-part rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in studies VX13-661-103 (Study 103, NCT02070744), VX14-661-106 (Study 106, NCT02347657), VX14-661-107 (Study 107, NCT02516410), VX14-661-108 (Study 108, NCT02392234), VX14-661-109 (Study 109, NCT02412111), and VX14-661-111 (Study 111, NCT02508207). The study is designed to evaluate the safety and efficacy of long-term treatment of VX-661 in combination with ivacaftor.

ReferenceCitation: Flume PA, Biner RF, Downey DG, Brown C, Jain M, Fischer R, De Boeck K, Sawicki GS, Chang P, Paz-Diaz H, Rubin JL, Yang Y, Hu X, Pasta DJ, Millar SJ, Campbell D, Wang X, Ahluwalia N, Owen CA, Wainwright CE; VX14-661-110 study group. Long-term safety and efficacy of tezacaftor-ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study. Lancet Respir Med. 2021 Jul;9(7):733-746. doi: 10.1016/S2213-2600(20)30510-5. Epub 2021 Feb 10. Erratum in: Lancet Respir Med. 2021 Apr;9(4):e38.

family: Flume

full_name: Patrick A Flume

given: Patrick A

family: Biner

full_name: Reta Fischer Biner

given: Reta Fischer

family: Downey

full_name: Damian G Downey

given: Damian G

family: Brown

full_name: Cynthia Brown

given: Cynthia

family: Jain

full_name: Manu Jain

given: Manu

family: Fischer

full_name: Rainald Fischer

given: Rainald

family: De Boeck

full_name: Kris De Boeck

given: Kris

family: Sawicki

full_name: Gregory S Sawicki

given: Gregory S

family: Chang

full_name: Philip Chang

given: Philip

family: Paz-Diaz

full_name: Hildegarde Paz-Diaz

given: Hildegarde

family: Rubin

full_name: Jaime L Rubin

given: Jaime L

family: Yang

full_name: Yoojung Yang

given: Yoojung

family: Hu

full_name: Xingdi Hu

given: Xingdi

family: Pasta

full_name: David J Pasta

given: David J

family: Millar

full_name: Stefanie J Millar

given: Stefanie J

family: Campbell

full_name: Daniel Campbell

given: Daniel

full_name: Xin Wang

given: Xin

family: Ahluwalia

full_name: Neil Ahluwalia

given: Neil

family: Owen

full_name: Caroline A Owen

given: Caroline A

family: Wainwright

full_name: Claire E Wainwright

given: Claire E

family: Gibson

full_name: Ronald L. Gibson

given: Ronald L.

suffix: Jr.

family: Rowe

full_name: Steven M. Rowe

given: Steven M.

family: Lechtzin

full_name: Noah Lechtzin

title: Long-term safety and efficacy of tezacaftor–ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
France
Israel
Ireland
Australia
Belgium
Spain
Denmark
Canada
United Kingdom


ReferenceCitation: Felip E, Altorki N, Zhou C, Csőszi T, Vynnychenko I, Goloborodko O, Luft A, Akopov A, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Voong D, Wu F, Yi J, Deng Y, McCleland M, Bennett E, Gitlitz B, Wakelee H; IMpower010 Investigators. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021 Oct 9;398(10308):1344-1357. doi: 10.1016/S0140-6736(21)02098-5. Epub 2021 Sep 20. Erratum in: Lancet. 2021 Sep 23;:.

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

family: Altorki

full_name: Nasser Altorki

given: Nasser

family: Zhou

full_name: Caicun Zhou

given: Caicun

family: Csőszi

full_name: Tibor Csőszi

given: Tibor

family: Vynnychenko

full_name: Ihor Vynnychenko

given: Ihor

family: Goloborodko

full_name: Oleksandr Goloborodko

given: Oleksandr

family: Luft

full_name: Alexander Luft

given: Alexander

family: Akopov

full_name: Andrey Akopov

given: Andrey

family: Martinez-Marti

full_name: Alex Martinez-Marti

given: Alex

family: Kenmotsu

full_name: Hirotsugu Kenmotsu

given: Hirotsugu

family: Chen

full_name: Yuh-Min Chen

given: Yuh-Min

family: Chella

full_name: Antonio Chella

given: Antonio

family: Sugawara

full_name: Shunichi Sugawara

given: Shunichi

family: Voong

full_name: David Voong

given: David

family: Wu

full_name: Fan Wu

given: Fan

family: Yi

full_name: Jing Yi

given: Jing

family: Deng

full_name: Yu Deng

given: Yu

family: McCleland

full_name: Mark McCleland

given: Mark

family: Bennett

full_name: Elizabeth Bennett

given: Elizabeth

family: Gitlitz

full_name: Barbara Gitlitz

given: Barbara

family: Wakelee

full_name: Heather Wakelee

given: Heather

journal_name: The Lancet

title: Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB–IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial

lead_sponsor: Hoffmann-La Roche

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Canada
Korea, Republic of
Hong Kong
Netherlands
Hungary
China
Portugal
United States
Germany
United Kingdom
Italy
Israel
Spain

location_facility: Kaohsiung Medical University Hospital; Department of Urology

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia

location_facility: Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway

location_facility: MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology

location_facility: Southern California Permanente Medical Group Bellflower

location_facility: Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique

location_facility: Hematology Oncology Associates of Fredericksburg, Inc.

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Florida Cancer Specialists-Broadway, Fort Myers

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Centro Oncologico de Galicia COG; Medical Oncology

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz

location_facility: First Hospital of China Medical University

location_facility: Centre Hospitalier de Saint-Quentin; Pharmacie-URCC

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Hematology and Oncology Associates at Bridgepoint

location_facility: MultiCare Regional Cancer Center - Auburn

location_facility: Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: Overlook Medical Center; Medical Diagnostic Associates

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

location_facility: Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)

location_facility: Hematology Oncology Associates of Northern New Jersey

location_facility: Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Centre Hospitalier de Mont de Marsan - Hopital Layne

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Scientific Research Institute of Oncology n.a. N.N. Petrov; Department of Oncogynecology

location_facility: University of Miami School of Medicine - Sylvester at Deerfield

location_facility: SCRI Florida Cancer Specialists North; Research Office North Region.

location_facility: Krankenhaus Martha-Maria; Halle-Dolau gGmbH

location_facility: Municipal Institution Odesa Regional Oncology Dispensary

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Chonnam National University Hwasun Hospital

location_facility: St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research

location_facility: Praxair Cancer Center at Danbury Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

location_facility: Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy

location_facility: Southern Illinois University, Simmons Cancer Institute

location_facility: University of Pecs, I st Dept of Internal Medicine

location_facility: City Clinical Hospital #1; Dpt of Oncology

location_facility: Centro Hospitalar de Lisboa Norte E.P.E - Hospital Pulido Valente

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale; S.C. Oncologia Pordenone

location_facility: Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Private Enterprise Private Manufacturing Company Acinus

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

location_facility: Affiliated Hospital of Guangdong Medical University

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: First Affiliated Hospital of Soochow University

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)

location_facility: Hospital de Sao Joao; Servico de Pneumologia

location_facility: MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Hospital of the University of Occupational and Environmental Health,Japan

location_facility: California Cancer Associates for Research & Excellence, Inc.

location_facility: Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica

location_facility: Principal Military Clinical Hospital n.a. N.N. Burdenko

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Municipal Institution SubCarpathian ClinicalOncological Centre; Chemotherapy department

location_facility: Hopital d Instruction des Armees de Sainte Anne

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Praxis fur Hamatologie und internistische Onkologie

location_facility: Quincy Medical Group; Canc Ctr at Blessing Hosp

location_facility: Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie

location_facility: Cancer Institute and Hospital Chinese Academy of Medical Sciences

location_facility: Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Compassionate Cancer Care Medical Group, Inc

location_facility: Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia

title: A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer

summary: This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.


ReferenceCitation: Wang H, Ma H, Sové RJ, Emens LA, Popel AS. Quantitative systems pharmacology model predictions for efficacy of atezolizumab and nab-paclitaxel in triple-negative breast cancer. J Immunother Cancer. 2021 Feb;9(2). pii: e002100. doi: 10.1136/jitc-2020-002100. Erratum in: J Immunother Cancer. 2021 Oct;9(10):.

family: Wang

full_name: Hanwen Wang

given: Hanwen

family: Ma

full_name: Huilin Ma

given: Huilin

family: Sové

full_name: Richard J Sové

given: Richard J

family: Emens

full_name: Leisha A Emens

given: Leisha A

family: Popel

full_name: Aleksander S Popel

given: Aleksander S

bso_classification: Chemistry

currency_apc_doaj: USD

journal_name: Journal for ImmunoTherapy of Cancer

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Adams S, Diéras V, Barrios CH, Winer EP, Schneeweiss A, Iwata H, Loi S, Patel S, Henschel V, Chui SY, Rugo HS, Emens LA, Schmid P. Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer. Ann Oncol. 2020 May;31(5):582-589. doi: 10.1016/j.annonc.2020.02.003. Epub 2020 Feb 20.

family: Adams

full_name: S. Adams

given: S.

family: Diéras

full_name: V. Diéras

given: V.

family: Barrios

full_name: C.H. Barrios

family: Winer

full_name: E.P. Winer

family: Schneeweiss

full_name: A. Schneeweiss

given: A.

family: Iwata

full_name: H. Iwata

given: H.

family: Loi

full_name: S. Loi

family: Patel

full_name: S. Patel

family: Henschel

full_name: V. Henschel

family: Chui

full_name: S.Y. Chui

family: Rugo

full_name: H.S. Rugo

full_name: L.A. Emens

family: Schmid

full_name: P. Schmid

given: P.

journal_name: Annals of Oncology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

ReferenceCitation: Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Investigators. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):44-59. doi: 10.1016/S1470-2045(19)30689-8. Epub 2019 Nov 27.

ReferenceCitation: Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Hegg R, Im SA, Shaw Wright G, Henschel V, Molinero L, Chui SY, Funke R, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Trial Investigators. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018 Nov 29;379(22):2108-2121. doi: 10.1056/NEJMoa1809615. Epub 2018 Oct 20.

name: From the Barts Cancer Institute, Queen Mary University of London, London (P.S.); Perlmutter Cancer Center, New York University School of Medicine, New York (S.A.); the Department of Medicine, University of California, San Francisco, San Francisco (H.S.R.), and Genentech, South San Francisco (L.M., S.Y.C., R.F.) — both in California; University Hospital Heidelberg, Heidelberg, Germany (A.S.); Centro de Pesquisa em Oncologia, Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Porto...

location_country:
Guatemala
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
Costa Rica
France
Japan
Panama
Poland
Thailand
Norway
Argentina
Canada
Slovenia
Korea, Republic of
Turkey
Colombia
Chile
Sweden
Hong Kong
Switzerland
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Brazil
Mexico
Czechia
Spain
Estonia
Latvia

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: St John of God Hospital; Bendat Cancer Centre

location_facility: Centro de Cancer Pontificie Universidad Catolica de Chile

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Univ of Calif, San Francisco; Breast Cancer Center

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: The Mount Siani Comprehensive Cancer Center

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: University Hospital of Patras Medical Oncology

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

location_facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Kaiser Permanente of Northern California

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)

location_facility: China Medical University Hospital; Surgery

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Texas;M.D. Anderson Cancer Center

location_facility: Institut De Cancerologie De L'Ouest; Medical Oncology

location_facility: Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie

location_facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Greenville Health System (GHS) Cancer Institute

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Medipol University MF; Oncology Department

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Saitama Medical University International Medical Center

location_facility: Cukurova Uni Faculty of Medicine; Medical Oncology

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Western General Hospital; Clinical Oncology

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Princess Alexandra Hospital; Division of Cancer Services

location_facility: Washington University School of Medicine

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

location_facility: MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Texas Oncology- El Paso Cancer Treatment Center Gateway

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii

location_facility: Centro de Oncologia e Investigacion Buenos Aires (COIBA)

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

location_facility: St. Johannes Hospital; Abt. für Hämatologie und Onkologie

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: North Estonia Medical Centre Foundation; Oncology Centre

location_facility: Wellmont Bristol Regional Medical Center

location_facility: Rush University Medical Center - Chicago

location_facility: Universitätsklinik Tübingen; Frauenklinik & Poliklinik

location_facility: Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Universitätsklinikum Schleswig-Holstein; Campus Lübeck

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Florida Cancer Specialists - SCRI; Pharmacy

location_facility: Fövárosi Önkormányzat uzsoki utcai Kórház

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: HOPITAL MICHALLON - CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE, Service d'oncologie Médicale

location_facility: St. Marianna University School of Medicine Hospital

location_facility: A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie

location_facility: Treatment and Prevention Institution Volyn Regional Oncology Dispensary

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

location_facility: Barbara Ann Karmanos Cancer Institute; Oncology

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Centre

location_facility: Instituto Estatal de Cancerologia Colima

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer

summary: This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.


title: A Multicenter, Prospective Epidemiologic Study of the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

summary: This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study also will generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 200 participants with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 60 months.

study_type: Observational

location_country:
Italy
Brazil
United States
Germany
France
Poland
Hungary
Argentina
Australia
Spain
Canada
United Kingdom

location_facility: Hospital Universitari de Bellvitge; Servicio de Oftalmologia

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: CHU Poitiers - CHR La Miletrie; Ophtalmologie

location_facility: University Health Network Toronto Western Hospital

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: Centre Odeon; Exploration Ophtalmologique

location_facility: Semmelweis Egyetem AOK, Szemeszeti Klinika

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Centre Paradis Monticelli; Ophtalmologie

intervention_type: Other


ReferenceCitation: Billings LK, Doshi A, Gouet D, Oviedo A, Rodbard HW, Tentolouris N, Grøn R, Halladin N, Jodar E. Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial. Diabetes Care. 2018 May;41(5):1009-1016. doi: 10.2337/dc17-1114. Epub 2018 Feb 26.

family: Billings

full_name: Liana K. Billings

given: Liana K.

family: Doshi

full_name: Ankur Doshi

given: Ankur

family: Gouet

full_name: Didier Gouet

given: Didier

family: Oviedo

full_name: Alejandra Oviedo

given: Alejandra

family: Rodbard

full_name: Helena W. Rodbard

given: Helena W.

family: Tentolouris

full_name: Nikolaos Tentolouris

given: Nikolaos

family: Grøn

full_name: Randi Grøn

given: Randi

family: Halladin

full_name: Natalie Halladin

given: Natalie

family: Jodar

full_name: Esteban Jodar

given: Esteban

ReferenceCitation: Billings LK, Agner BFR, Altuntas Y, Grøn R, Halladin N, Klonoff DC, Tentolouris N, Jódar E. The Benefit of Insulin Degludec/Liraglutide (IDegLira) Compared With Basal-Bolus Insulin Therapy is Consistent Across Participant Subgroups With Type 2 Diabetes in the DUAL VII Randomized Trial. J Diabetes Sci Technol. 2021 May;15(3):636-645. doi: 10.1177/1932296820906888. Epub 2020 Feb 28.

name: Department of Medicine, NorthShore University HealthSystem/University of Chicago Pritzker School of Medicine, Evanston, IL, USA

family: Agner

full_name: Bue F. Ross Agner

given: Bue F. Ross

name: Endocrinology and Metabolism Clinic, University of Health Sciences, Şişli Hamidiye Etfal Teaching and Research Hospital, Istanbul, Turkey

family: Altuntas

full_name: Yuksel Altuntas

given: Yuksel

name: Mills-Peninsula Medical Center, San Mateo, CA, USA

family: Klonoff

full_name: David C. Klonoff

given: David C.

name: 1st Department of Propaedeutic Internal Medicine, Laiko General Hospital, National and Kapodistrian University of Athens, Medical School, Greece

name: Department of Endocrinology and Clinical Nutrition, University Hospital Quirónsalud Madrid & Ruber Juan Bravo, Universidad Europea de Madrid, Spain

family: Jódar

full_name: Esteban Jódar

journal_name: Journal of Diabetes Science and Technology

oa_host_type: repository

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Meneghini L, Doshi A, Gouet D, Vilsbøll T, Begtrup K, Őrsy P, Ranthe MF, Lingvay I. Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin. Diabet Med. 2020 Feb;37(2):267-276. doi: 10.1111/dme.14178. Epub 2019 Nov 28.

name: University of Texas Southwestern Medical Center and Parkland Health & Hospital System Dallas TX USA

family: Meneghini

name: Steno Diabetes Center Copenhagen University of Copenhagen Copenhagen Denmark

repository_institution: University of Copenhagen - Research at the University of Copenhagen

title: Insulin degludec/liraglutide ( ID egLira) maintains glycaemic control and improves clinical outcomes, regardless of pre‐trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin

location_country:
Mexico
France
Czechia
Greece
Israel
Slovakia
Hungary
Argentina
Russian Federation
Spain
Turkey
United States

title: A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

summary: This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.