lead_sponsor: Janssen Research & Development, LLC

location_country:
Peru
Malaysia
Australia
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Poland
Lithuania
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Chile
Sweden
Netherlands
Vietnam
Bulgaria
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Estonia
Latvia

location_facility: Hospital Nuestra Señora de la Misericordia

location_facility: Inese Petrova General Practitioner Practice

location_facility: Suretech Hospital and Research Centre Limited

location_facility: J. Lewis Research Inc./Jordan River Family Medicine

location_facility: Nemocnica arm. generala L. Svobodu Svidnik, a.s.,

location_facility: Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Detweiler Family Medicine and Associates

location_facility: Powiatowe Centrum Medyczne w Wołowie Sp. z o.o.

location_facility: LLC Outpatient department of Private Security Guards and Detectives

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut

location_facility: Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú

location_facility: Institute Of Epidimiology And Microbiology

location_facility: Paradigm Clinical Research Centers, Inc.

location_facility: Taipei Medical University Shuang-Ho Hospital

location_facility: J. Lewis research Inc./ Foothill Family Care

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA

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

location_facility: Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Odesa City Municipal Institution Polyclinic #20

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: NZOZ Centrum Badań Klinicznych,Piotr Napora,Lekarze Spółka Partnerska

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Inlita, JSC, Lazdynai KTC clinical trial site

location_facility: Hospital Civil de Guadalajara Dr. Juan I. Menchaca

location_facility: CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: California Allergy & Asthma Medical Group Inc.

location_facility: Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.

location_facility: Siauliai Republican Hospital, Public Institution

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'

location_facility: HIRG, LLC dba Health Innovation Research Group

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Limited Liability company 'MSMC' Euromed

location_facility: Rajiv Gandhi Institute of Medical Sciences

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: SMZ Süd - Kaiser Franz Josef Spital Wien

location_facility: Vilnius University Hospital Santaros Klinikos, Public Institution

location_facility: The Catholic university of Korea, ST Vincent Hospital

location_facility: Centro de Estudos Clínicos do Interior Paulista - CECIP

location_facility: Bamrasnaradura Infectious Disease Institute

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF

location_facility: Hospital Interzonal General de Agudos Dr. Jose Penna

location_facility: Fuzhou General Hospital of Nanjing Military Command

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Irmandade Da Santa Casa de Misericordia de Sao Paulo

location_facility: Department for Heart Failure and Valvular Disease

location_facility: Johns Hopkins University School of Medicine

location_facility: San Diego Sports Medicine & Family Health Center

location_facility: J. Lewis research Inc./ Foothill Family Clinic South

location_facility: University Of Texas Medical Branch At Galveston

location_facility: Taipei Medical University-Wan Fang Hospital

location_facility: Preferred Primary Care Physicians Research

location_facility: SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Carolina Institute for Clinical Research

location_facility: Dr. Anil K Gupta Medicine Professional Corporation

location_facility: University of Texas Southwestern Medical Center

title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection Who Are at Risk of Developing Complications

summary: The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.

status_simplified: Unknown


design_allocation: Randomized

intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Hoffmann-La Roche

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Peru
Finland
Cuba
Russian Federation
Morocco
Spain
France
Panama
Poland
Montenegro
Argentina
Korea, Republic of
South Africa
Chile
Singapore
Hungary
Algeria
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Bosnia and Herzegovina
Serbia
Mexico
Egypt
Kazakhstan
Turkey

location_facility: Instituto Nacional de Oncología y Radiología (INOR)

location_facility: Centre hospitalo-univerisitaire de Rouiba;Service d'oncologie médicale

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Cancer Hospital , Chinese Academy of Medical

location_facility: The First Affiliated Hospital, Chongqing Medical University

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

location_facility: Oncocentro Serviços Medicos E Hospitalares Ltda

location_facility: Ankara Oncology Hospital; Medical Oncology Department

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: The First Affiliated Hospital Of Jinzhou Medical University

location_facility: Centre Alexis Vautrin; Oncologie Medicale

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

location_facility: AirForce Specialized Hospital; Clinical Oncology

location_facility: The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Caritas-Krankenhaus St. Josef; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"

location_facility: Clinical Centre Nis, Clinic for Oncology

location_facility: Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe

location_facility: Institut National D'oncologie Sidi Med Benabdellah

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Western General Hospital; Edinburgh Cancer Center

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: James Lind Centro de Investigación Del Cáncer

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: CHU Constantine; Service d'Oncologie Médicale

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The Oncology centre,Durban; Clinical Oncology

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

location_facility: Centro de Oncologia de Santa Catarina LTDA

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

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Medipol University MF; Oncology Department

location_facility: The Affiliated Hospital of Medical College Qingdao University

location_facility: Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: National Cancer Centre; Medical Oncology

location_facility: Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department

location_facility: Clinica San Felipe; Centro de Investigacion Unidad de Oncologia Medica

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Clinique specialise Menara; Oncology Medical

location_facility: Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Hospital de Cruces; Servicio de Oncologia

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

location_facility: Magee-Woman's Hospital; UPMC Pinnacle Cancer Center

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Instituto de Investigaciones Metabolicas (Idim)

location_facility: Instituto de Pesquisa Grupo NotreDame Intermedica

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Hacettepe University Medical Faculty; Department of Internal Medicine

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

location_facility: Świętokrzyskie Centrum Onkologii; Dział Chemioterapii

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: University Clinical Center of the Republic of Srpska

location_facility: the First Affiliated Hospital of Bengbu Medical College

location_facility: Clinical Center of Montenegro; Clinic for Oncology and Radiotherapy

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Centre Hospitalier Universitaire Hassan II

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Harbin Medical University Cancer Hospital

location_facility: Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

location_facility: INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.

location_facility: City Clinical Oncology Dispensary, SPb SBIH CCOD

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale

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

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Pendik Training and Research Hospital; Medical Oncology

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Centre Georges-François Lecler; Ctr de Lutte Contre le Canc

location_facility: Private Healthcare Institution Clinical Hospital RZhD Medicine

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

location_facility: University of Pretoria Oncology Department; Medical Oncology

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Institut Paoli-Calmettes; Oncologie Medicale 1

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Fujian Medical University Union Hospital

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer

summary: This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

lead_sponsor_type: industriel

status_simplified: Ongoing


ReferenceType: derived

ReferenceCitation: Silverberg JI, DeLozier A, Sun L, Thyssen JP, Kim B, Yosipovitch G, Nunes FP, Gugiu PC, Doll HA, Eichenfield LF. Psychometric properties of the itch numeric rating scale, skin pain numeric rating scale, and atopic dermatitis sleep scale in adult patients with moderate-to-severe atopic dermatitis. Health Qual Life Outcomes. 2021 Oct 23;19(1):247. doi: 10.1186/s12955-021-01877-8.

family: Silverberg

full_name: Jonathan I. Silverberg

given: Jonathan I.

sequence: first

family: DeLozier

full_name: Amy DeLozier

given: Amy

sequence: additional

family: Sun

full_name: Luna Sun

given: Luna

family: Thyssen

full_name: Jacob P. Thyssen

given: Jacob P.

family: Kim

full_name: Brian Kim

given: Brian

family: Yosipovitch

full_name: Gil Yosipovitch

given: Gil

family: Nunes

full_name: Fabio P. Nunes

given: Fabio P.

family: Gugiu

full_name: P. Cristian Gugiu

given: P. Cristian

family: Doll

full_name: Helen A. Doll

given: Helen A.

family: Eichenfield

full_name: Lawrence F. Eichenfield

given: Lawrence F.

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Health and Quality of Life Outcomes

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Thyssen JP, Buhl T, Fernández-Peñas P, Kabashima K, Chen S, Lu N, DeLozier AM, Casillas M, Ständer S. Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7. Dermatol Ther (Heidelb). 2021 Oct;11(5):1599-1611. doi: 10.1007/s13555-021-00577-x. Epub 2021 Jul 18.

family: Buhl

full_name: Timo Buhl

given: Timo

family: Fernández-Peñas

full_name: Pablo Fernández-Peñas

given: Pablo

family: Kabashima

full_name: Kenji Kabashima

given: Kenji

family: Chen

full_name: Sherry Chen

given: Sherry

family: Lu

full_name: Na Lu

full_name: Amy M. DeLozier

given: Amy M.

family: Casillas

full_name: Marta Casillas

given: Marta

family: Ständer

full_name: Sonja Ständer

given: Sonja

ReferenceCitation: King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.

journal_name: American Journal of Clinical Dermatology

ReferenceCitation: Reich K, DeLozier AM, Nunes FP, Thyssen JP, Eichenfield LF, Wollenberg A, Ross Terres JA, Watts SD, Chen YF, Simpson EL, Silverberg JI. Baricitinib improves symptoms in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: patient-reported outcomes from two randomized monotherapy phase III trials. J Dermatolog Treat. 2020 Nov 22:1-10. doi: 10.1080/09546634.2020.1839008. [Epub ahead of print]

name: Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Skinflammation® Center, Hamburg and Dermatologikum Berlin, Berlin, Germany

name: Eli Lilly and Company, Indianapolis, IN, USA

name: Department of Dermatology and Allergy, Herlev and Gentofte Hospital and University of Copenhagen, Copenhagen, Denmark

name: Departments of Dermatology and Pediatrics, University of California, San Diego and Rady Children’s Hospital, San Diego, CA, USA

name: Department of Dermatology and Allergology, Ludwig Maximilian University, Munich, Germany

name: Department of Dermatology, Oregon Health and Science University, Portland, OR, USA

name: Department of Dermatology, George Washington University School of Medicine, Washington, DC, USA

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.

location_country:
Italy
India
Mexico
France
Czechia
Japan
Russian Federation
Denmark
Germany
Taiwan

location_facility: Chennai Meenakshi Multispeciality Hospital

location_facility: Clínica Enfermedades Crónicas y Procedimientos Especiales SC

location_facility: Queen's Square Dermatology and Allergology

location_facility: SPb SBHI Skin-venerologic dispensary #10

location_facility: CRI Centro Regiomontano de Investigacion S.C.

location_facility: Universität Leipzig - Universitätsklinikum

location_facility: Hospital Univ. Dr. Jose Eleuterio Gonzalez

location_facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

location_facility: Praxis für Ganzheitliche Dermatologie im Ärztehaus

location_facility: GBUZ Clinical dermatology and venereological dispensary

location_facility: Azienda Ospedaliera - Universitaria Pisana

location_facility: Kyoto Prefectural University of Medicine

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Russian state medical-stomatological university n.a. Evdokimov

location_facility: All India Institue of Medical Sciences (AIIMS)

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Taipei Medical University- Shuang Ho Hospital

location_facility: Aarhus Universitehospital Marselisborg Centret

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: State scientific centre for dermatovenerology and cosmetolog

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Byramjee Jeejeebhoy Medical College & Civil Hospital

location_facility: Dr. D. Y. Patil Medical College & Hospital

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

summary: The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.


title: A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults Who Are Virologically Suppressed

summary: This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required.

status: Active, not recruiting

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Overton ET, Richmond G, Rizzardini G, Jaeger H, Orrell C, Nagimova F, Bredeek F, García Deltoro M, Swindells S, Andrade-Villanueva JF, Wong A, Khuong-Josses MA, Van Solingen-Ristea R, van Eygen V, Crauwels H, Ford S, Talarico C, Benn P, Wang Y, Hudson KJ, Chounta V, Cutrell A, Patel P, Shaefer M, Margolis DA, Smith KY, Vanveggel S, Spreen W. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021 Dec 19;396(10267):1994-2005. doi: 10.1016/S0140-6736(20)32666-0. Epub 2020 Dec 9.

ReferenceCitation: Jaeger H, Overton ET, Richmond G, Rizzardini G, Andrade-Villanueva JF, Mngqibisa R, Hermida AO, Thalme A, Belonosova E, Ajana F, Benn PD, Wang Y, Hudson KJ, Español CM, Ford SL, Crauwels H, Margolis DA, Talarico CL, Smith KY, van Eygen V, Van Solingen-Ristea R, Vanveggel S, Spreen WR. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet HIV. 2021 Nov;8(11):e679-e689. doi: 10.1016/S2352-3018(21)00185-5. Epub 2021 Oct 11.

family: Jaeger

full_name: Hans Jaeger

given: Hans

family: Overton

full_name: Edgar T Overton

given: Edgar T

family: Richmond

full_name: Gary Richmond

given: Gary

family: Rizzardini

full_name: Giuliano Rizzardini

given: Giuliano

family: Andrade-Villanueva

full_name: Jaime Federico Andrade-Villanueva

given: Jaime Federico

family: Mngqibisa

full_name: Rosie Mngqibisa

given: Rosie

family: Hermida

full_name: Antonio Ocampo Hermida

given: Antonio Ocampo

family: Thalme

full_name: Anders Thalme

given: Anders

family: Belonosova

full_name: Elena Belonosova

given: Elena

family: Ajana

full_name: Faïza Ajana

given: Faïza

family: Benn

full_name: Paul D Benn

given: Paul D

family: Wang

full_name: Yuanyuan Wang

given: Yuanyuan

family: Hudson

full_name: Krischan J Hudson

given: Krischan J

family: Español

full_name: Carlos Martín Español

given: Carlos Martín

family: Ford

full_name: Susan L Ford

given: Susan L

family: Crauwels

full_name: Herta Crauwels

given: Herta

family: Margolis

full_name: David A Margolis

given: David A

family: Talarico

full_name: Christine L Talarico

given: Christine L

family: Smith

full_name: Kimberly Y Smith

given: Kimberly Y

family: van Eygen

full_name: Veerle van Eygen

given: Veerle

family: Van Solingen-Ristea

full_name: Rodica Van Solingen-Ristea

given: Rodica

family: Vanveggel

full_name: Simon Vanveggel

given: Simon

family: Spreen

full_name: William R Spreen

ReferenceCitation: Chounta V, Overton ET, Mills A, Swindells S, Benn PD, Vanveggel S, van Solingen-Ristea R, Wang Y, Hudson KJ, Shaefer MS, Margolis DA, Smith KY, Spreen WR. Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M). Patient. 2021 Nov;14(6):849-862. doi: 10.1007/s40271-021-00524-0. Epub 2021 May 31.

journal_name: The Patient - Patient-Centered Outcomes Research

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

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Italy
United States
South Africa
Sweden
Mexico
Germany
France
Argentina
Australia
Russian Federation
Spain
Canada
Korea, Republic of


status: Terminated

lead_sponsor: AstraZeneca

location_country:
United States
Germany
France
Japan
Poland
Romania
Hungary
Belgium
Australia
Puerto Rico
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Centro de Atencion Especializada (CAE) OROITU

location_facility: Quillen College of Medicine, East TN State University

location_facility: Hospital Universitario La Fe de Valencia

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska

location_facility: Gemeinschaftspraxis für Neurologie und Psychiatrie

location_facility: Institute for Neurodegenerative Disorders

location_facility: Australian Alzheimer's Research Foundation

location_facility: Fundacion ACE-Institut Catala de Neurociences Aplicades

location_facility: True North Clinical Research Halifax, LLC

location_facility: National Institute for Longevity Sciences NCGG

location_facility: The Multiple Sclerosis Center of Atlanta

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Memory Enhancement Center of America, Inc.

location_facility: The Florey Institute of Neuroscience and Mental Health

location_facility: University of Rochester School of Medicine

location_facility: Territory Neurology & Research Institute

location_facility: Centrum Zdrowia Psychicznego Biomed - Jan Latala

location_facility: Premiere Research Institute at Palm Beach Neurology

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

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Advanced Memory Research Institute of New Jersey

location_facility: Centre Hospitalier Universitaire La Timone

location_facility: Tokyo Women's Medical University Hospital

ipd_sharing: Yes

study_completion_date_type: Actual

type: Other Identifier

title: A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)

summary: This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in participants with early Alzheimer's disease dementia at the time of entry into study I8D-MC-AZES.


ReferenceType: result

ReferenceCitation: Newsome PN, Buchholtz K, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal AJ, Sejling AS, Harrison SA; NN9931-4296 Investigators. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. N Engl J Med. 2021 Mar 25;384(12):1113-1124. doi: 10.1056/NEJMoa2028395. Epub 2020 Nov 13.

name: From the National Institute for Health Research Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, University of Birmingham, and the Liver Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham (P.N.N.), and the Radcliffe Department of Medicine, University of Oxford, Oxford (S.A.H.) — all in the United Kingdom; Novo Nordisk, Søborg, Denmark (K.B., M.L., A.-S.S...

family: Newsome

full_name: Philip N. Newsome

given: Philip N.

family: Buchholtz

full_name: Kristine Buchholtz

given: Kristine

family: Cusi

full_name: Kenneth Cusi

given: Kenneth

family: Linder

full_name: Martin Linder

given: Martin

family: Okanoue

full_name: Takeshi Okanoue

given: Takeshi

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

family: Sanyal

full_name: Arun J. Sanyal

given: Arun J.

family: Sejling

full_name: Anne-Sophie Sejling

given: Anne-Sophie

family: Harrison

full_name: Stephen A. Harrison

given: Stephen A.

journal_name: New England Journal of Medicine

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Harrison SA, Calanna S, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal A, Sejling AS, Newsome PN. Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers. Contemp Clin Trials. 2020 Oct;97:106174. doi: 10.1016/j.cct.2020.106174. Epub 2020 Oct 8.

family: Calanna

full_name: Salvatore Calanna

given: Salvatore

full_name: Arun Sanyal

given: Arun

journal_name: Contemporary Clinical Trials

oa_host_type: publisher

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

location_country:
Austria
Sweden
Netherlands
Spain
Finland
France
Bulgaria
Greece
Japan
Australia
Belgium
Puerto Rico
Russian Federation
Denmark
United States
United Kingdom
Canada

title: This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis

summary: Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis


title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Subjects Hospitalized With Respiratory Syncytial Virus

summary: The purpose of this study is to characterize the Pharmacokinetic and to confirm the popPK model derived from healthy volunteers in hospitalized adults who are infected with respiratory syncytial virus (RSV) and to determine in adults who are hospitalized with respiratory syncytial virus (RSV) infection the dose response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

location_country:
Brazil
Sweden
Mexico
Netherlands
Germany
France
Bulgaria
Japan
Korea, Republic of
Malaysia
Poland
Belgium
Argentina
Australia
Spain
United States
United Kingdom
Canada
Taiwan


ReferenceCitation: Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4.

family: Sun

full_name: Jong-Mu Sun

given: Jong-Mu

family: Shen

full_name: Lin Shen

given: Lin

family: Shah

full_name: Manish A Shah

given: Manish A

family: Enzinger

full_name: Peter Enzinger

given: Peter

family: Adenis

full_name: Antoine Adenis

given: Antoine

family: Doi

full_name: Toshihiko Doi

given: Toshihiko

family: Kojima

full_name: Takashi Kojima

given: Takashi

family: Metges

full_name: Jean-Philippe Metges

given: Jean-Philippe

family: Li

full_name: Zhigang Li

given: Zhigang

family: Kim

full_name: Sung-Bae Kim

given: Sung-Bae

family: Cho

full_name: Byoung Chul Cho

given: Byoung Chul

family: Mansoor

full_name: Wasat Mansoor

given: Wasat

full_name: Shau-Hsuan Li

given: Shau-Hsuan

family: Sunpaweravong

full_name: Patrapim Sunpaweravong

given: Patrapim

family: Maqueda

full_name: Maria Alsina Maqueda

given: Maria Alsina

family: Goekkurt

full_name: Eray Goekkurt

given: Eray

family: Hara

full_name: Hiroki Hara

given: Hiroki

family: Antunes

full_name: Luis Antunes

given: Luis

family: Fountzilas

full_name: Christos Fountzilas

given: Christos

family: Tsuji

full_name: Akihito Tsuji

given: Akihito

family: Oliden

full_name: Victor Castro Oliden

given: Victor Castro

family: Liu

full_name: Qi Liu

given: Qi

full_name: Sukrut Shah

given: Sukrut

family: Bhagia

full_name: Pooja Bhagia

given: Pooja

family: Kato

full_name: Ken Kato

given: Ken

ReferenceCitation: Kato K, Shah MA, Enzinger P, Bennouna J, Shen L, Adenis A, Sun JM, Cho BC, Özgüroğlu M, Kojima T, Kostorov V, Hierro C, Zhu Y, McLean LA, Shah S, Doi T. KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer. Future Oncol. 2019 Apr;15(10):1057-1066. doi: 10.2217/fon-2018-0609. Epub 2019 Feb 8.

name: National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

name: Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York Avenue, Room Y1247, New York, NY 10065, USA

name: Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215-5450, USA

name: University Hospital of Nantes, Digestive Oncology, 1 Place Alexis Ricordeau, Nantes, 44000, France

name: Peking University Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing, 100142, PR China

name: Institut du Cancer de Montpellier, 208 Avenue des Apothicaries, Montpellier, 34298, France

name: Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Seoul, Republic of Korea

name: Severance Hospital, Yonsei University Health System, 50-1 Yonsei-ro, Seoul, Republic of Korea

name: Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Koca Mustafa Paşa Mahallesi, Cerrahpaşa Caddesi No. 53, Istanbul, 34096, Turkey

name: National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan

name: Leningrad Regional Oncology Dispensary, Ulitsa Savushkina, 126, Saint Petersburg, 197374, Russian Federation

name: Vall d'Hebron University Hospital & Vall d'Hebron Institute of Oncology (VHIO), 119-129 Pg vall d'Hebron, Barcelona, 08035, Spain

name: Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA

location_country:
Peru
Guatemala
Malaysia
Romania
Australia
Russian Federation
Denmark
Taiwan
Costa Rica
France
Japan
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Hong Kong
China
United States
Germany
United Kingdom
Brazil
Spain
Turkey

acronym: First-line Esophageal Carcinoma Study with Chemo vs. Chemo + Pembrolizumab

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto. ( Site 0203)

location_facility: Humanity Health Research Centre ( Site 1603)

location_facility: Ibaraki Prefectural Central Hospital ( Site 0918)

location_facility: St. Marianna University School of Medicine Hospital ( Site 0903)

location_facility: Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0210)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 1403)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 1701)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0901)

location_facility: National Cancer Center Hospital East ( Site 0908)

location_facility: Chang Gung Med Foundation. Kaohsiung Branch ( Site 1906)

location_facility: ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 2601)

location_facility: Washington University School of Medicine ( Site 0031)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0904)

location_facility: Princess Alexandra Hospital ( Site 2005)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0209)

location_facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0603)

location_facility: Kaiser Permanente Southern California ( Site 0003)

location_facility: Outeniqua Cancercare Oncology Unit ( Site 2504)

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0114)

location_facility: University of Tsukuba Hospital ( Site 0910)

location_facility: Leningrad Regional Oncology Center ( Site 0405)

location_facility: National Cheng Kung University Hospital ( Site 1905)

location_facility: Universitaetsklinikum Leipzig ( Site 1501)

location_facility: Centro de Investigacion Oncologica ( Site 1402)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0406)

location_facility: Hospital Regional de Concepcion Dr. Guillermo Grant Benavente ( Site 1003)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0120)

location_facility: Hospital Alemao Oswaldo Cruz ( Site 0207)

location_facility: CETUS Hospital Dia Oncologia ( Site 0208)

location_facility: The Christie NHS Foundation Trust ( Site 1100)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 1903)

location_facility: Odense Universitetshospital ( Site 2300)

location_facility: Hospital Privado Centro Medico Cordoba ( Site 0601)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2407)

location_facility: Sanatorio Allende - Cordoba ( Site 0604)

location_facility: Hokkaido University Hospital ( Site 0916)

location_facility: Kansai Medical University Hospital ( Site 0931)

location_facility: China Medical University Hospital ( Site 1904)

location_facility: Kuang Tien General Hospital ( Site 1909)

location_facility: Chi Mei Medical Center Liuying ( Site 1907)

location_facility: Osaka International Cancer Institute ( Site 0923)

location_facility: Weill Cornell Medical College ( Site 0024)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0801)

location_facility: Kobe City Medical Center General Hospital ( Site 0929)

location_facility: The Medical Oncology Centre of Rosebank ( Site 2506)

location_facility: CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0305)

location_facility: Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1502)

location_facility: Lothian University Hospitals NHS Trust ( Site 1101)

location_facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0602)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0914)

location_facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2402)

location_facility: Taipei Medical University Shuang Ho Hospital ( Site 1908)

location_facility: Clinica de Hematologia e Oncologia Viver Ltda ( Site 0211)

location_facility: Klinik fuer Haematologie. Onkologie und Gastroenterologie ( Site 1508)

location_facility: St Petersburg City Clinical Oncology Dispensary ( Site 0409)

location_facility: Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0701)

location_facility: Kumamoto University Hospital ( Site 0919)

location_facility: Zhongda Hospital Southeast University ( Site 0125)

location_facility: Staedtisches Klinikum Dresden ( Site 1507)

location_facility: Hospital Universitari Vall d Hebron ( Site 0702)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0906)

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 0803)

location_facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0206)

location_facility: Istanbul Medeniyet Universitesi Goztepe EAH ( Site 0807)

location_facility: Severance Hospital Yonsei University Health System ( Site 1302)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 0403)

location_facility: Chonnam National University Hwasun Hospital ( Site 1305)

location_facility: Niigata Cancer Center Hospital ( Site 0924)

location_facility: Pamela Youde Nethersole Eastern Hospital ( Site 1601)

location_facility: Universitatsklinikum Mannheim GmbH ( Site 1504)

location_facility: National Taiwan University Hospital ( Site 1900)

location_facility: Fudan University Shanghai Cancer Center ( Site 0108)

location_facility: Pontificia Universidad Catolica de Chile ( Site 1001)

location_facility: CIMCA Centro de Investigacion y Manejo del Cancer ( Site 2600)

location_facility: Hospital Universitario Reina Sofia ( Site 0706)

location_facility: Hospital Clinico Universidad de Chile ( Site 1002)

location_facility: National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0402)

location_facility: The Affiliated Tumour Hospital of Harbin Medical University ( Site 0102)

location_facility: III. Medizinische Klinik Klinikum rechts der Isar ( Site 1506)

location_facility: The First Affiliated Hospital of Anhui Medical University ( Site 0112)

location_facility: Hospital Sao Vicente de Paulo ( Site 0204)

location_facility: Roswell Park Cancer Institute ( Site 0004)

location_facility: PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0110)

location_facility: Hospital Universitario Central de Asturias ( Site 0708)

location_facility: Medical Park Izmir Hastanesi ( Site 0800)

location_facility: University Malaya Medical Centre ( Site 1802)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 1902)

location_facility: The Ottawa Hospital - Cancer Care ( Site 0501)

location_facility: Seoul National University Cancer Hospital ( Site 1301)

location_facility: Beacon International Specialist Centre ( Site 1803)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 2501)

location_facility: WITS Clinical Research CMJAH Clinical Trial Site ( Site 2500)

location_facility: Bumrungrad International Hospital ( Site 2203)

location_facility: Institut Mutualiste Montsouris ( Site 0300)

location_facility: University Hospitals Cleveland Medical Center ( Site 0002)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 2508)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 0119)

location_facility: CHU de Saint Etienne Hopital Nord ( Site 0309)

location_facility: Complejo Hospitalario Virgen De La Victoria ( Site 0705)

location_facility: Tongji Medical College Huazhong University of Science and Technology ( Site 0109)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0201)

location_facility: National Cancer Center Hospital ( Site 0907)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2404)

location_facility: Osaka General Medical Center ( Site 0912)

location_facility: University of Tennessee Medical Center Knoxville ( Site 0017)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0804)

location_facility: Peking Union Medical College Hospital ( Site 0123)

location_facility: Hospital Universitario La Paz ( Site 0700)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0200)

location_facility: Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 1702)

location_facility: Osaka Medical College Hospital ( Site 0925)

location_facility: Aichi Cancer Center Hospital ( Site 0902)

location_facility: Fujian Provincial Cancer Hospital ( Site 0104)

location_facility: University of Maryland Medical Center ( Site 0013)

location_facility: Princess Margaret Cancer Centre ( Site 0505)

location_facility: Princess Margaret Hospital. ( Site 1602)

location_facility: Peter MacCallum Cancer Centre ( Site 2003)

location_facility: Institut du Cancer de Montpellier ( Site 0306)

location_facility: The University of Chicago Medical Center ( Site 0001)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 1705)

location_facility: UPMC Cancer Center/Hillman Cancer Center ( Site 0015)

location_facility: CISSS de la Monteregie-Centre ( Site 0504)

location_facility: S C Oncocenter Oncologie Medicala S R L ( Site 2405)

title: A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)

summary:
The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin and 5-FU as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma.

The overall primary efficacy hypotheses are as follows:

In participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive (defined as combined positive score [CPS] ≥10), ESCC participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, overall survival (OS) is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.
In participants with ESCC, participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.


title: A Phase 3 Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC).

summary: This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).

status: Completed

lead_sponsor: Sumitomo Dainippon Pharma Oncology, Inc

location_country:
Italy
United States
Hong Kong
Netherlands
Spain
Germany
France
Czechia
Japan
Israel
Singapore
Belgium
Australia
China
Canada
Korea, Republic of

location_facility: Suburban Hematology-Oncology Associates, PC - Lawrenceville

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Elizabeth Tweesteden Ziekenhuis locatie Tilburg

location_facility: Hôpital Morvan - CHRU de Brest - cancérologie et d'hématolog

location_facility: The Barzilai Medical Center - Oncology Institute

location_facility: Emory University/Winship Cancer Institute

location_facility: Hôpital Privé des Côtes d'Armor - Service oncologie

location_facility: Charite - Campus Benjamin Franklin (Cbf)

location_facility: The Chaim Sheba Medical Centre - Division of Oncology

location_facility: Florida Cancer Specialists & Research Institute Fort Myers

location_facility: Tel Aviv Sourasky Medical Center - Oncology

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: University of California-San Diego/Moores UCSD Cancer Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: AOU Città della Salute e della Scienza di Torino - Molinette

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Texas Oncology - Wichita Falls Texoma Cancer Center

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Schwerpunkpraxis für Hämatologie und Onkologie

location_facility: The cancer insitute hospital of JFCR (Japanese Foundation For Cancer Research)

location_facility: Hospital Universitario Central de Asturias

location_facility: Cancer Research Network of Nebraska / Oncology Associates PC

location_facility: US Oncology - Virginia Cancer Specialists, PC

location_facility: Medical Hospital, Tokyo Medical and Dental University

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Missouri Baptist Medical Center ACCRU Network Site

location_facility: Saint Michael's Hospital Li Ka Shing Knowledge Institute

location_facility: University of Toronto - Sunnybrook Health Sciences Centre

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Memorial Cancer Institute at Memorial Hospital

location_facility: Complexo Hospital Universitario A Coruña

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: North Shore Hematology Oncology Associates

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Sunshine Coast Hospital and Health Service

location_facility: Hôpital Européen Georges Pompidou - Digestive Oncology

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: AOU Ospedali Riuniti Umberto I - GM.Lanc

location_facility: ST. Marianna University School of Medicine

location_facility: Ziv Medical Center (The Rebecca Sieff Hospital)

location_facility: Università degli studi della Campania "L.Vanvitelli"

location_facility: Baptist Health Medical Group Oncology, LLC

location_facility: Indiana University Health Goshen Center for Cancer Care

location_facility: AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan

location_facility: MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Kobe City Medical Center General Hospital

location_facility: St Mary's Hospital & Regional Med Center

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: Hospital Universitario Fundacion Alcorcon (HUFA)

location_facility: Consorci Hospital General Universitari Valencia (CHGUV)

location_facility: Ospedale Guglielmo da Saliceto, AUSL Piacenza

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol

status_simplified: Completed


title: A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation

summary: This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.

design_allocation: Non-Randomized

lead_sponsor: Forma Therapeutics, Inc.

location_country:
Italy
United States
Germany
France
Australia
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Box Hill Hospital, Monash University and Eastern Health Clinical School

location_facility: Universitätsklinikum Münster Medizinische Klinik A, Hämatologie, Hämostaseologi

location_facility: Severance Hospital, Yonsei Health System

location_facility: Klinikum Chemnitz gGmbH - Klinik fuer Innere Medizin III

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin

location_facility: Ospedale Mazzoni - UOC Ematologia Ascoli Piceno

location_facility: Institut Català d'Oncologia-Hospital Duran i Reynals

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Landeszentrum fuer Zell- und Gentherapie

location_facility: Cornell University Weill Medical College

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Seoul National University Bundang Hospital

location_facility: Northwestern University Feinberg School of Medicine

location_facility: START - Hospital Universitario Fundación Jiménez Díaz

location_facility: Dipartimento di Oncologia Medica - IRST IRCC

location_facility: Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris

location_facility: Robert-Bosch-Krankenhaus (RBK) Onkologisches Zentrum

location_facility: Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord

location_facility: Hopitaux Universitaires Est Parisien Hopital Saint-Antoine

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital Brabois

location_facility: Indiana Blood and Marrow Transplantation Research, LLC

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: Sarah Cannon Research Institute - Tennessee Oncology

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Rimini Hematology, Department of Oncology and Hematoloy


lead_sponsor: Ipsen

location_country:
Brazil
Chile
Peru
Mexico
Spain
France
Lithuania
Israel
Belgium
Argentina
Australia
Russian Federation
Germany
United Kingdom
Colombia
Ukraine

location_facility: Ministry of healthcare of the Russian Federation

location_facility: Penza Regional Clinical Hospital n.a. N.N.Burdenko

location_facility: Municipal Healthcare Institution "Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval", Urology Department

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Centro de Investigaciones Clinicas - CIC

location_facility: National Hospital for Neurology and Neurosurgery - UCL

location_facility: Groupe Hospitalo-Universitaire Pierre Caremau

location_facility: Hospital Privado - Centro Médico de Córdoba

location_facility: Kliniken Maria Hilf GmbH - Krankenhaus St. Franziskus

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Royal National Orthopaedic Hospital Trust

location_facility: Universidade Estadual de Campinas - Cidade Universitária Zeferino Vaz

location_facility: Solano & Terront Servicios Medicos LTDA- Unidad Integral de Endocrinologia

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Asociacion IPS Medicos Internistas de Caldas

location_facility: St. Petersburg Research Institute of Phthisiopulmonology

location_facility: Universitätsklinikum Bonn Klinik und Poliklinik für Urologie

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Hospital de Clinicas, Federal University of Paraná

location_facility: Hospital Universitario "Dr. José Eleuterio González"

location_facility: Unidad de Investigación de la Clínica Internacional Sede San Borja

location_facility: The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Scientific research institute of urology and interventional radiology n. a. N. A. Lopatkin

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

location_facility: Santa Casa de Misericórdia de Porto Alegre - Hospital Santa Clara

title: A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units Of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis

summary: The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).


title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo for the Treatment of Anemia Due to the IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions.

acronym: MEDALIST

summary:
The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions.

ReferenceCitation: Porter J. Beyond transfusion therapy: new therapies in thalassemia including drugs, alternate donor transplant, and gene therapy. Hematology Am Soc Hematol Educ Program. 2018 Nov 30;2018(1):361-370. doi: 10.1182/asheducation-2018.1.361. Review.

name: University College London, London, United Kingdom

family: Porter

full_name: John Porter

given: John

journal_name: Hematology

oa_colors: green other

evidence: open (via free article)

repository_institution: PubMed Central - Europe PMC

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Piga A, Perrotta S, Gamberini MR, Voskaridou E, Melpignano A, Filosa A, Caruso V, Pietrangelo A, Longo F, Tartaglione I, Borgna-Pignatti C, Zhang X, Laadem A, Sherman ML, Attie KM. Luspatercept improves hemoglobin levels and blood transfusion requirements in a study of patients with β-thalassemia. Blood. 2019 Mar 21;133(12):1279-1289. doi: 10.1182/blood-2018-10-879247. Epub 2019 Jan 7.

name: Department of Clinical and Biological Sciences, Turin University, Turin, Italy;

family: Piga

full_name: Antonio Piga

given: Antonio

name: Dipartimento della Donna, del Bambino e della Chirurgia Generale e Specialistica, Università degli Studi della Campania “Luigi Vanvitelli,” Naples, Italy;

family: Perrotta

full_name: Silverio Perrotta

given: Silverio

name: Thalassemia Unit, Arcispedale S. Anna, Ferrara, Italy;

family: Gamberini

full_name: Maria Rita Gamberini

given: Maria Rita

family: Voskaridou

full_name: Ersi Voskaridou

given: Ersi

family: Melpignano

full_name: Angela Melpignano

given: Angela

name: Rare Red Blood Cell Disease Unit, Cardarelli Hospital, Naples, Italy;

family: Filosa

full_name: Aldo Filosa

given: Aldo

name: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi, Catania, Italy;

family: Caruso

full_name: Vincenzo Caruso

given: Vincenzo

name: Centro Emocromatosi e Malattie Eredometaboliche del Fegato, Medicina 2, Modena, Italy;

family: Pietrangelo

full_name: Antonello Pietrangelo

given: Antonello

family: Longo

full_name: Filomena Longo

given: Filomena

family: Tartaglione

full_name: Immacolata Tartaglione

given: Immacolata

name: Section of Pediatrics, Department of Medical Sciences, University of Ferrara, Ferrara, Italy;

family: Borgna-Pignatti

full_name: Caterina Borgna-Pignatti

given: Caterina

family: Zhang

full_name: Xiaosha Zhang

given: Xiaosha

family: Laadem

full_name: Abderrahmane Laadem

given: Abderrahmane

family: Sherman

full_name: Matthew L. Sherman

given: Matthew L.

family: Attie

full_name: Kenneth M. Attie

given: Kenneth M.

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Fenaux P, Platzbecker U, Mufti GJ, Garcia-Manero G, Buckstein R, Santini V, Díez-Campelo M, Finelli C, Cazzola M, Ilhan O, Sekeres MA, Falantes JF, Arrizabalaga B, Salvi F, Giai V, Vyas P, Bowen D, Selleslag D, DeZern AE, Jurcic JG, Germing U, Götze KS, Quesnel B, Beyne-Rauzy O, Cluzeau T, Voso MT, Mazure D, Vellenga E, Greenberg PL, Hellström-Lindberg E, Zeidan AM, Adès L, Verma A, Savona MR, Laadem A, Benzohra A, Zhang J, Rampersad A, Dunshee DR, Linde PG, Sherman ML, Komrokji RS, List AF. Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes. N Engl J Med. 2020 Jan 9;382(2):140-151. doi: 10.1056/NEJMoa1908892.

name: From Service d’Hématologie Séniors, Hôpital Saint-Louis, Assistance Publique–Hôpitaux de Paris and Université Paris 7, Paris (P.F., L.A.), Service des Maladies du Sang, Hôpital Huriez, Centre Hospitalier Universitaire (CHU) de Lille, Lille (B.Q.), the Department of Internal Medicine, CHU Toulouse, Institut Universitaire du Cancer de Toulouse, Toulouse (O.B.-R.), and Université Cote d’Azur, Département d’Hématologie Clinique, CHU Nice, Nice (T.C.) — all in France; Medical Clinic and Policlinic 1,...

repository_institution: Tor Vergata University - Cineca Institutional Research Information System

repository_institution: University of Florence - Florence Research

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

ReferenceCitation: Komrokji RS. Luspatercept in Myelodysplastic Syndromes: Who and When? Hematol Oncol Clin North Am. 2020 Apr;34(2):393-400. doi: 10.1016/j.hoc.2019.10.004. Epub 2020 Jan 21. Review.

journal_name: Hematology/Oncology Clinics of North America

ReferenceCitation: Fenaux P, Kiladjian JJ, Platzbecker U. Luspatercept for the treatment of anemia in myelodysplastic syndromes and primary myelofibrosis. Blood. 2019 Feb 21;133(8):790-794. doi: 10.1182/blood-2018-11-876888. Epub 2019 Jan 2. Review.

name: Service Hématologie Séniors, Hôpital St Louis, Assistance Publique–Hôpitaux de Paris, Paris, France;

name: Department of Hematology, Université Paris Diderot, Paris, France;

name: Centre d’Investigations Cliniques, Assistance Publique–Hôpitaux de Paris, Paris, France; and

name: Policlinic 1, Hematology and Cellular Therapy, Leipzig University Hospital, Leipzig, Germany

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Belgium
Spain
Turkey
Canada
United Kingdom

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Instituto Catalan de Oncologia-Hospital Duran i Reynals

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

location_facility: Montefiore Medical Center Albert Einstein Cancer Center

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Cleveland Clinic Taussig Cancer Institute

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital Universitario Central de Asturias

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi


ReferenceCitation: Moore KN, Bookman M, Sehouli J, Miller A, Anderson C, Scambia G, Myers T, Taskiran C, Robison K, Mäenpää J, Willmott L, Colombo N, Thomes-Pepin J, Liontos M, Gold MA, Garcia Y, Sharma SK, Darus CJ, Aghajanian C, Okamoto A, Wu X, Safin R, Wu F, Molinero L, Maiya V, Khor VK, Lin YG, Pignata S. Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG 3015/ENGOT-OV39). J Clin Oncol. 2021 Jun 10;39(17):1842-1855. doi: 10.1200/JCO.21.00306. Epub 2021 Apr 23. Erratum in: J Clin Oncol. 2021 Jul 20;39(21):2420.

name: Gynecologic Oncology Group Foundation (GOG-F) and Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, Oklahoma City, OK

name: Sarah Cannon Research Institute, Nashville, TN

family: Moore

full_name: Kathleen N. Moore

given: Kathleen N.

name: GOG-F and Kaiser Permanente Northern California, San Francisco, CA

family: Bookman

full_name: Michael Bookman

given: Michael

name: Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie (North-Eastern German Society of Gynaecologic Oncology; NOGGO), Berlin, Germany and Charité-Medical University of Berlin (Campus Virchow Klinikum), Berlin, Germany

family: Sehouli

full_name: Jalid Sehouli

given: Jalid

name: GOG-F and Roswell Park Comprehensive Cancer Center, Buffalo, NY

family: Miller

full_name: Austin Miller

given: Austin

name: GOG-F and Willamette Valley Cancer Institute, Eugene, OR

family: Anderson

full_name: Charles Anderson

given: Charles

name: Mario Negri Gynecologic Oncology (MaNGO) and Fondazione Policlinico Universitario Gemelli Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Rome, Italy

family: Scambia

full_name: Giovanni Scambia

given: Giovanni

name: GOG-F and Baystate Medical Center, Springfield, MA

family: Myers

full_name: Tashanna Myers

given: Tashanna

name: Turkish Society of Gynecologic Oncology (TRSGO) and Koç University School of Medicine, Istanbul, Turkey

name: Vehbi Koç Vakfı American Hospital, Istanbul, Turkey

family: Taskiran

full_name: Cagatay Taskiran

given: Cagatay

name: GOG-F and Women and Infants Hospital, Providence, RI

family: Robison

full_name: Katina Robison

given: Katina

name: Nordic Society of Gynaecological Oncology (NSGO) and Tampere University and University Hospital, Tampere, Finland

family: Mäenpää

full_name: Johanna Mäenpää

given: Johanna

name: GOG-F and Arizona Oncology Associates, PC, Phoenix, AZ

family: Willmott

full_name: Lyndsay Willmott

given: Lyndsay

name: European Institute of Oncology, IRCCS, and University of Milan-Bicocca, Milan, Italy

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

name: GOG-F and Minnesota Oncology, Maplewood, MN

family: Thomes-Pepin

full_name: Jessica Thomes-Pepin

given: Jessica

name: Hellenic Cooperative Oncology Group (HeCOG) and National & Kapodistrian University of Athens, Athens, Greece

family: Liontos

full_name: Michalis Liontos

given: Michalis

name: GOG-F and Oklahoma Cancer Specialists, Tulsa, OK

family: Gold

full_name: Michael A. Gold

given: Michael A.

name: Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Parc Taulí University Hospital, Universitat Autònoma de Barcelona, Sabadell, Spain

family: Garcia

full_name: Yolanda Garcia

given: Yolanda

name: GOG-F and Department of Obstetrics/Gynecology, Amita Adventist Hinsdale Hospital, Hinsdale, IL

family: Sharma

full_name: Sudarshan K. Sharma

given: Sudarshan K.

name: GOG-F and Maine Medical Center, Scarborough, ME; Current Affiliation: Earle A. Chiles Research Institute at Providence Cancer Institute, Portland, OR

family: Darus

full_name: Christopher J. Darus

given: Christopher J.

name: GOG-F and Memorial Sloan Kettering Cancer Center, New York, NY

family: Aghajanian

full_name: Carol Aghajanian

given: Carol

name: The Jikei University School of Medicine, Tokyo, Japan

family: Okamoto

full_name: Aikou Okamoto

given: Aikou

name: Department of Gynecological Oncology, Fudan University Shanghai Cancer Center, Shanghai, China

family: Wu

full_name: Xiaohua Wu

given: Xiaohua

name: Republican Clinical Oncology Dispensary of the Ministry of Health of Republic of Tatarstan, Kazan, Russian Federation

family: Safin

full_name: Rustem Safin

given: Rustem

name: Biostatistics, Roche (China) Holding Ltd, Shanghai, China

full_name: Fan Wu

given: Fan

family: Molinero

full_name: Luciana Molinero

given: Luciana

family: Maiya

full_name: Vidya Maiya

given: Vidya

name: Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) and Istituto Nazionale Tumori IRCCS Fondazione G Pascale, Napoli, Italy

repository_institution: Koç University - Digital Collections portal

repositories_institution: Koç University - Digital Collections portal

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Moore KN, Pignata S. Trials in progress: IMagyn050/GOG 3015/ENGOT-OV39. A Phase III, multicenter, randomized study of atezolizumab versus placebo administered in combination with paclitaxel, carboplatin, and bevacizumab to patients with newly-diagnosed stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer. Int J Gynecol Cancer. 2019 Jan 10. pii: ijgc-2018-000071. doi: 10.1136/ijgc-2018-000071. [Epub ahead of print]

journal_name: International Journal of Gynecologic Cancer

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
France
Japan
Poland
Norway
Korea, Republic of
Sweden
China
Germany
United States
Italy
Austria
Brazil
Czechia
Israel
Spain
Turkey

location_facility: St.Vincent Health System; Gynecologic Oncology

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Monument Health Rapid City Hospital, Inc.

location_facility: Arcispedale Santa Maria Nuova; Oncologia

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

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

location_facility: University of Kentucky; Gynecologic Oncology

location_facility: Universitätsklinikum Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT)

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: Texas Oncology, P.A. - Tyler; Tyler Cancer Center

location_facility: Turku Uni Central Hospital; Gynaecology Dept

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: University Hospital of Patras Medical Oncology

location_facility: Cooper Health System; MD Anderson Cancer Center

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Onkologicka klinika UK 2.LF a FN v Motole

location_facility: Texas Oncology San Antonio Medical Center

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Chaim Sheba Medical Center; Obstetrics and Gynecology

location_facility: Dell Seton Medical Center at UT-Seton Infusion Center; Research Department

location_facility: Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii

location_facility: The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: DN Greenwald Center; DN Greenwald Center

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: California Pacific Medical Center Research Institute

location_facility: University of Pennsylvania Health System; Cancer Center

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: Koc University Medical Faculty; Department of Gynecology & Obstetrics

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: A.O.Spedali Civili; Ostetricia e Ginecologia

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: University of Iowa Hospital & Clinic; Division of Hematology/Oncology

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

location_facility: Clinique Sainte Catherine; Hopital De Semaine

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: IRCCS S. Raffaele; Ginecologia Oncologica

location_facility: St. Elizabeth Edgewood; Cancer Care Center" for Account St. Elizabeth Edgewood

location_facility: Ohio State University, Arthur James Cancer Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Ospedale Mauriziano Umberto 1; Ginecologia - Oncologia

location_facility: St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: Meir Medical Center; Obstetrics and Gynecology

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Szpital Kliniczny Przemienienia Panskiego; Oddział Ginekologii Onkologicznej

location_facility: Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie

location_facility: Ankara University Medical Faculty; Medikal Onkoloji

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Metro-Minnesota Community Oncology Research Consortium

location_facility: Policlinico A. Gemelli e C.I.C.; Area Salute della Donna

location_facility: Oklahoma Cancer Specialists and Research Institute

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Memorial Sloan Kettering Cancer Center; MSK Monmouth

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: University of California San Francisco Cancer Center

location_facility: A. O. Città della Salute e della Scienza; Unità di Oncologia Ginecologica

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Southwest Gynecologic Oncology Associates, Inc.

location_facility: The Royal North Shore Hospital; Northern Sydney Cancer Centre

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH

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

location_facility: Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

location_facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

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

location_facility: Ospedale Degli Infermi - Faenza; Oncologia Medica

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

location_facility: Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins

location_facility: University Hospital Ostrava; Fakultní nemocnice

location_facility: Niigata University Medical & Dental Hospital

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: Arizona Oncology Associates, PC - HAL; Arizona Oncology Associates, PC - HAL

location_facility: New York Univ Medical Center; Obstetrics & Gynecolog

location_facility: Uni Hospital of Ioannina; Oncology Dept.

location_facility: Maine Medical Partners Women's Health; Gyn-Oncology

location_facility: Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Harbin Medical University Cancer Hospital

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: Fundacion Hospital de Alcorcon; Servicio de Oncologia

location_facility: Women's hospital school of medicine Zhejiang University

location_facility: University of Oklahoma; Stephenson Oklahoma Canc Ctr

location_facility: Northeast Georgia Medical Center; Oncology Research Dept-5C

location_facility: Moores Cancer Center at UC San Diego Health

location_facility: Istanbul University Cerrahpasa Medical Faculty; Obstetrics and Gynecology

location_facility: Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej

location_facility: Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd

location_facility: Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Tianjin Central Hospital of Gynecology Obstetrics.

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Krankenhaus Der Barmherzigen Brüder Graz; Gynäkologie

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

location_facility: Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute

location_facility: Sarasota Memorial Health Care System; Cancer Research Program

location_facility: UT Southwestern Medical Center at Dallas; Department of Pathology

location_facility: Universitätsklinikum Dresden; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: EUROMEDICA General Clinic of Thessaloniki; Medical Oncology Dept - Oncomedicare

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

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

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Ospedale Silvestrini; Oncologia ed Ematologia

location_facility: Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie

location_facility: Novant Health Presbyterain Medical Center

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

title: A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

summary: This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.


ReferenceCitation: Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.

family: Marconi

full_name: Lorenzo Marconi

given: Lorenzo

family: Sun

full_name: Maxine Sun

given: Maxine

family: Beisland

full_name: Christian Beisland

given: Christian

family: Klatte

full_name: Tobias Klatte

given: Tobias

family: Ljungberg

full_name: Boerje Ljungberg

given: Boerje

family: Stewart

full_name: Grant D. Stewart

given: Grant D.

family: Dabestani

full_name: Saeed Dabestani

given: Saeed

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

family: Bex

full_name: Axel Bex

given: Axel

journal_name: Clinical Genitourinary Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

intervention_type: Other

location_country:
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Chile
Netherlands
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Czechia
Israel
Spain
Turkey

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Cleveland Clinic Foundation; Hematology and Oncology

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: New York Oncology Hematology at Albany Medical Center

location_facility: Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction

location_facility: Sint Franciscus Gasthuis; Inwendige Geneeskunde

location_facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: Florida Cancer Specialists-Broadway, Fort Myers

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Chang Gung Medical Foundation-Linkou, Urinary Oncology

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU

location_facility: McGill University Health Centre - Glen Site

location_facility: Division of Urological surgery; Department of surgery, Chulalongkorn University

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

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

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology

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

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

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: National Taiwan University Hospital, Department of Urology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Ankara Uni School of Medicine; Medical Oncology

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Tokyo Women's Medical University Medical Center East

location_facility: Fondazione IRCCS Policlinico San Matteo, Oncologia

location_facility: University of Rochester Medical Center; Urology

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: Nouvel Hopital Civil - CHU Strasbourg; Urologie

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: North York General Hospital; Inpatient Pharmacy

location_facility: Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Sourasky Medical Center; Oncology Department

location_facility: Belinson Medical Center, Division of Oncology

location_facility: VU Medisch Centrum; VU University Medical Center

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: General University Hospital; CLINIC OF ONCOLOGY

location_facility: TAIPEI VETERANS GENERAL HOSPITAL, Urology

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: Narodowy Inst.Onkol.im.Skłodowskiej-Curie Państw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: University of North Carolina at Chapel Hill

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

location_facility: Chaim Sheba medical center, Oncology division

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

location_facility: University of Utah; Huntsman Cancer Hospital

location_facility: University of California Irvine Medical Center

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Tokyo Medical And Dental University, Medical Hospital

location_facility: Niigata University Medical & Dental Hospital

location_facility: CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

location_facility: Clinic for Urology, Clinical Center of Serbia; Clinic for Urology

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: Hillcrest Hospital; Hirsch Cancer Center

location_facility: University of Oklahoma; Stephenson Oklahoma Canc Ctr

location_facility: Institut Mutualiste Montsouris; Oncologie

location_facility: China Medical University Hospital; Urology

location_facility: Vanderbilt University Medical Center; Vanderbilt University

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

location_facility: Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec

location_facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

location_facility: Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome

location_facility: Royal Brisbane & Women's Hosp; Cancer Care Serv

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: Emory Uni - Winship Cancer Center; Hematology/Oncology

location_facility: Clinic for Urology; Military Medical Academy

location_facility: Altai Region Oncology Dispensory; Oncology

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

location_facility: Gazi University Medical Faculty; Department of İnternal Medicine

location_facility: Fox Chase Cancer Center; Hematology/Oncology

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Loyola University Medical Center, Cardinal Bernardin Cancer Center

location_facility: University of Texas Southwestern Medical Center

title: A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy

summary: This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.


title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients With Heart Failure and Impaired Systolic Function

acronym: STANDUP AHF

summary: A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function

ReferenceCitation: Felker GM, McMurray JJV, Cleland JG, O'Connor CM, Teerlink JR, Voors AA, Belohlavek J, Böhm M, Borentain M, Bueno H, Cole RT, DeSouza MM, Ezekowitz JA, Filippatos G, Lang NN, Kessler PD, Martinez FA, Mebazaa A, Metra M, Mosterd A, Pang PS, Ponikowski P, Sato N, Seiffert D, Ye J. Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study. JACC Heart Fail. 2021 Feb;9(2):146-157. doi: 10.1016/j.jchf.2020.10.012. Epub 2020 Nov 25.

family: Felker

full_name: G. Michael Felker

given: G. Michael

family: McMurray

full_name: John J.V. McMurray

given: John J.V.

family: Cleland

full_name: John G. Cleland

given: John G.

family: O’Connor

full_name: Christopher M. O’Connor

given: Christopher M.

family: Teerlink

full_name: John R. Teerlink

given: John R.

family: Voors

full_name: Adriaan A. Voors

given: Adriaan A.

family: Belohlavek

full_name: Jan Belohlavek

given: Jan

family: Böhm

full_name: Michael Böhm

given: Michael

family: Borentain

full_name: Maria Borentain

given: Maria

family: Bueno

full_name: Hector Bueno

given: Hector

family: Cole

full_name: Robert T. Cole

given: Robert T.

family: DeSouza

full_name: Mary M. DeSouza

given: Mary M.

family: Ezekowitz

full_name: Justin A. Ezekowitz

given: Justin A.

family: Filippatos

full_name: Gerasimos Filippatos

given: Gerasimos

family: Lang

full_name: Ninian N. Lang

given: Ninian N.

family: Kessler

full_name: Paul D. Kessler

given: Paul D.

family: Martinez

full_name: Felipe A. Martinez

given: Felipe A.

family: Mebazaa

full_name: Alex Mebazaa

given: Alex

family: Metra

full_name: Marco Metra

given: Marco

family: Mosterd

full_name: Arend Mosterd

given: Arend

family: Pang

full_name: Peter S. Pang

given: Peter S.

family: Ponikowski

full_name: Piotr Ponikowski

given: Piotr

family: Sato

full_name: Naoki Sato

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Cowart D, Venuti RP, Lynch K, Guptill JT, Noveck RJ, Foo SY. A Phase 1 Randomized Study of Single Intravenous Infusions of the Novel Nitroxyl Donor BMS-986231 in Healthy Volunteers. J Clin Pharmacol. 2019 May;59(5):717-730. doi: 10.1002/jcph.1364. Epub 2019 Jan 31.

name: Cardioxyl Pharmaceuticals, Inc. Chapel Hill NC USA

name: Duke Early Phase Clinical Research Unit Durham NC USA

title: A Phase 1 Randomized Study of Single Intravenous Infusions of the Novel Nitroxyl Donor BMS‐986231 in Healthy Volunteers

location_country:
Italy
United States
Netherlands
Germany
France
Czechia
Greece
Japan
Poland
Argentina
Spain
Canada
United Kingdom

location_facility: Medical University of South Carolina - PPDS

location_facility: University of North Carolina at Chapel Hill

location_facility: Indiana University Health Methodist Hospital

location_facility: Wexner Medical Center at The Ohio State University

location_facility: University of Arizona Sarver Heart Center


title: Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

acronym: CheckMate 816

summary:
The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.

This study has multiple primary endpoints.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Brazil
United States
Spain
France
Japan
Greece
Romania
Hungary
Argentina
China
Turkey
Canada
Korea, Republic of
Taiwan

location_facility: Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha

location_facility: Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: PERSONAL Oncologia de Precisao e Personalizada

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Prof. Dr. Ion Chiricuta Institute Of Oncology Day Care Dep

location_facility: UNC Regional Physicians Hematology & Oncology

location_facility: Charleston Hematology Oncology Associates, Pa

location_facility: Los Angeles Hematology/Oncology Medical Group

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Texas Oncology, PA - South Austin Cancer Center

location_facility: Hematology-Oncology Associates Of Fredricksburg, Inc