title: Real-life Effectiveness of Vortioxetine in Patients With Major Depressive Disorder: Non-interventional, Multi-national, Prospective Cohort Study to Assess Real-life Effectiveness of Vortioxetine

acronym: RELIEVE

summary:
Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences.

Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tolerated antidepressant, there is a need to determine the effectiveness of vortioxetine in real life routine practice.

The study aim is to examine the real-life effectiveness of vortioxetine on functioning, depressive symptom relief, cognition and quality of life.

This is an observational, multi-national, study in patients with MDD initiating treatment with vortioxetine. Information will be collected by the physician, from the patient and their medical record at three time points - baseline, week 12 and week 24 (end of follow-up). This study will be conducted in six countries. In total 2,100 patients are planned for enrolment.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Almeida SS, Christensen MC, Simonsen K, Adair M. Effectiveness of vortioxetine in patients with major depressive disorder and co-morbid generalized anxiety disorder in routine clinical practice: A subgroup analysis of the RELIEVE study. J Psychopharmacol. 2023 Mar;37(3):279-288. doi: 10.1177/02698811221132468. Epub 2022 Nov 15.

oa_colors: green hybrid

lead_sponsor: H. Lundbeck A/S

location_country:
United States
Italy
Canada
France

location_facility: Universita Cattolica del Sacro Cuore (University of Sacred Heart Policlinico A. Gemelli) (IT0018)

location_facility: Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana (IT0035)

location_facility: Centre Hospitalier Universitaire de Nimes (FR0018)

location_facility: Centre Hospitalier De Martigues (FR0064)

location_facility: Università degli Studi di Brescia (IT0029)

location_facility: Universita Degli Studi Di Catania - Azienda Policlinico (IT0030)

location_facility: Universita Degli Studi Magna Graecia Di Catanzaro (IT0006)

location_facility: Center For Advanced Improvement (US0011)

location_facility: Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma (IT0032)

location_facility: Azienda Toscana nord ovest zona Apuane (IT0039)

location_facility: Dipartimento Salute Mentale ASL Lecce (IT0009)

location_facility: Policlinico Universitario Di Messina (IT0031)

location_facility: Millenia Psychiatry and Research, Inc. (US0015)

location_facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur - Clinique de Psychiatrie et de Psychologie Medicale (FR0041)

location_facility: Pharmacology Research Institute (US0045)

location_facility: Harmonex Neuroscience Research Inc (US0072)

location_facility: CHU Clermont-Ferrand, Hopital Gabriel Montpied (FR0037)

location_facility: North County Clinical Research (Nccr) (US0071)

location_facility: Hopital Albert Michallon- CHU Grenoble Alpes (FR0021)

location_facility: Casa di Cura Villa San Benedetto Menni, Suore Ospedaliere (IT0025)

location_facility: International Research Associates LLC (US0060)

location_facility: Queen's University-Hotel Dieu Hospital (CA0011)

location_facility: Northwest Behavioral Research Center (US0007)

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga (IT0004)

location_facility: Chatham-Kent Clinical Trials Research Centre (CA0007)

location_facility: University Of Kansas Cancer Center (US0078)

location_facility: Dr. Dominique Januel, MD Office of (FR0044)

location_facility: Dr Lousqui Charles MD, Office of (FR0033)

location_facility: Pneumology Clinic - AO San Gerardo (IT0017)

location_facility: St. Charles Psychiatric Associates - Midwest Research Group (US0039)

location_facility: Quest Therapeutics Of Avon Lake (US0002)

location_facility: Professional Health Care of Pinellas (US0050)

location_facility: Chokka Center For Integrative Health (CA0001)

location_facility: DSM Giulianova - ospedale di Giulianova (IT0019)

location_facility: Dr. Philippe Remaud MD, Office of (FR0010)

location_facility: Dr. Norbert Rigaud Md, Office Of (FR0028)

location_facility: Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0034)

location_facility: Southern Illinois Associates LLC (US0079)

location_facility: Azienda Ospedaliera San Paolo - Universita Degli Studi Di Milano (IT0014)

location_facility: Rochester Center For Behavioral Medicine (US0059)

location_facility: Disturbi Depressivi Ospedale Luigi Sacco Polo Universitario Psichiatria 2 - CTDD (IT0033)

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer - Hôpital Sainte Musse (FR0019)

location_facility: Dr Philippe Marmor, MD, Office of (FR0035)

location_facility: St. Joseph's Health Care London - Parkwood Institute (Regional Mental Health Care London and Parkwood Hospital) (CA0004)

location_facility: Viking Clinical Research Center LLC (US0033)

location_facility: Start Clinic For Mood And Anxiety Disorders (CA0006)


type: EudraCT Number

title: COMBI-APlus: Open-label, Phase IIIb Study of Dabrafenib in COMBInation With Trametinib in the Adjuvant Treatment of Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes of an Adapted Pyrexia AE-management Algorithm (Plus)

acronym: COMBI-APlus

summary:
This is an open-label Phase IIIb study of dabrafenib in combination with trametinib in the adjuvant treatment of melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm, as well as safety, efficacy and health-related outcomes.

Approximately 600 subjects will be enrolled to receive dabrafenib (150 mg BID) and trametinib (2 mg once daily) combination therapy for 12 months. At enrollment, subjects will be instructed on the pyrexia management algorithm.

This study consists of two Periods for Enrolled subjects:

Treatment Period - subjects will receive up to 12 months of treatment.
Follow-up Period - subjects will be followed through 24 months from their first dose date for relapse, and through end of study for overall survival. Follow-up will start once treatment is complete or is prematurely discontinued and continue through the end of the study, regardless of disease recurrence.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Atkinson V, Robert C, Grob JJ, Gogas H, Dutriaux C, Demidov L, Gupta A, Menzies AM, Ryll B, Miranda F, Banerjee H, Lau M, Del Vecchio M. Improved pyrexia-related outcomes associated with an adapted pyrexia adverse event management algorithm in patients treated with adjuvant dabrafenib plus trametinib: Primary results of COMBI-APlus. Eur J Cancer. 2022 Mar;163:79-87. doi: 10.1016/j.ejca.2021.12.015. Epub 2022 Jan 14.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ipd_sharing: Undecided

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Slovenia
Lithuania
Portugal
Slovakia
Hungary
Latvia
Italy
Norway
United Kingdom
Sweden
Greece
Russian Federation
Israel

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: POLAR-A

lead_sponsor: Egetis Therapeutics

summary: This study is to evaluate PledOx for prevention of chronic chemotherapy induced peripheral neuropathy induced by oxaliplatin in patients with Stage III or high-risk Stage II colorectal cancer (CRC).

ReferenceCitation: Pfeiffer P, Lustberg M, Nasstrom J, Carlsson S, Persson A, Nagahama F, Cavaletti G, Glimelius B, Muro K. Calmangafodipir for Prevention of Oxaliplatin-Induced Peripheral Neuropathy: Two Placebo-Controlled, Randomized Phase 3 Studies (POLAR-A/POLAR-M). JNCI Cancer Spectr. 2022 Nov 1;6(6):pkac075. doi: 10.1093/jncics/pkac075.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;boa.unimib.it;sdu.dk

unpaywall_oa_status: gold

publisher_dissemination: Oxford University Press

sponsor_collaborators:
Egetis Therapeutics
Solasia Pharma K.K.

location_facility: National Hospital Organization Osaka National Hospital

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Hôpital Nord Franche-Comté Site du Mittan

location_facility: Centre Hospitalier Départemental de Vendée - Unité de recherche clinique

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Mid Essex Hospital Services NHS Trust - Broomfield Hospital

location_facility: Onkodok GmbH / Onkologische Schwerpunktpraxis

location_facility: KMUH: Kaohsiung Medical University Chung-Ho Memorial Hospital

status: Terminated

title: A Phase 3, Double-blind, Multicenter, Placebo-controlled Study of PledOx Used on Top of Modified FOLFOX6 (5-FU/FA and Oxaliplatin) to Prevent Chemotherapy Induced Peripheral Neuropathy (CIPN) in the Adjuvant Treatment of Patients With Stage III or High-risk Stage II Colorectal Cancer

primary_purpose: Prevention

source: euctr

design_allocation: Randomized

location_country:
Germany
Italy
United Kingdom
Japan
Belgium
Korea, Republic of
Spain
Taiwan
Czechia
France

ipd_sharing: No

status_simplified: Unknown


title: Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

summary: to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

lead_sponsor: HighLife SAS

sponsor_collaborators:
HighLife SAS
ICON plc

location_country:
Germany
Poland
United Kingdom
Australia
Belgium
France

location_facility: Heart Center, University Hospital Dresden

location_facility: Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital

location_facility: Centre Hospitalo-Universitaire de Nantes

location_facility: University Hospitals of Leicester NHS Trust

location_facility: University Hospital of Lord's Transfiguration

location_facility: University Heart Center Freiburg - Bad Krozingen

intervention_type: Device

status_simplified: Ongoing


lead_sponsor: Merck Sharp & Dohme LLC

summary:
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are:

Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR).
Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS).

location_facility: Waverly Hematology Oncology ( Site 0054)

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)

location_facility: Hospital Sant Creu i Sant Pau ( Site 1711)

location_facility: CLIMERS Clinical Medical Research ( Site 0306)

location_facility: Birmingham Heartlands Hospital ( Site 1910)

location_facility: Alabama Oncology Bruno Cancer Center ( Site 0001)

location_facility: Aichi Cancer Center Hospital ( Site 0803)

location_facility: Universitaetsmedizin Goettingen ( Site 1557)

location_facility: National Cancer Center Hospital East ( Site 0801)

location_facility: Studienzentrum Aschaffenburg ( Site 1575)

location_facility: SPb Central Clinical Railway Hospital ( Site 2003)

location_facility: Regional Centre of Oncology-Thoracic organs ( Site 2219)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 2225)

location_facility: CISSS de la Monteregie-Centre ( Site 0101)

location_facility: Namik Kemal Universitesi Tip Fakultesi ( Site 2100)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 2223)

location_facility: Ege Universitesi Tip Fakultesi ( Site 2109)

location_facility: Erciyes Universitesi Tip Fakultesi ( Site 2108)

location_facility: Columbus Regional Research Institute ( Site 0099)

location_facility: CIUSSS de la Mauricie et du Centre du Quebec ( Site 0106)

location_facility: Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573)

location_facility: Kanazawa University Hospital ( Site 0811)

location_facility: SPb SBHI City Clinical Oncological Dispensary ( Site 2001)

location_facility: Axis Heilsa S. de R.L. de C.V. ( Site 0301)

location_facility: Hospital Universitario 12 de Octubre ( Site 1716)

location_facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0250)

location_facility: InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1564)

location_facility: Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551)

location_facility: Osaka International Cancer Institute ( Site 0809)

location_facility: Universitaetsklinikum Regensburg ( Site 1562)

location_facility: Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)

location_facility: Townsville General Hospital ( Site 1202)

location_facility: MidCentral DHB Palmerston North Hospital ( Site 1102)

location_facility: Hopital d'Instruction des Armees Begin ( Site 1413)

location_facility: Helios Klinikum Erfurt GmbH ( Site 1552)

location_facility: Hospital Italiano Regional del Sur ( Site 0509)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)

location_facility: Instituto Medico Rio Cuarto ( Site 0501)

location_facility: Chungbuk National University Hospital ( Site 1002)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)

location_facility: Kansai Medical University Hospital ( Site 0804)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)

location_facility: Centre Hospitalier De Chauny ( Site 1411)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0263)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334)

location_facility: Southern Medical Day Care Centre ( Site 1200)

location_facility: Ondokuz Mays Üniversitesi Tp Fakültesi Hastanesi-Oncology ( Site 2106)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 0046)

location_facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516)

location_facility: Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site

location_facility: The Cancer Institute Hospital of JFCR ( Site 0800)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260)

location_facility: Niigata Cancer Center Hospital ( Site 0808)

location_facility: Colchester General Hospital ( Site 1911)

location_facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0903)

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)

location_facility: Social Medical Center - Otto Wagner Hospital ( Site 1301)

location_facility: Hopital Cite de la Sante de Laval ( Site 0105)

location_facility: Southend University Hospital NHS Foundation Trust ( Site 1913)

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0255)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)

location_facility: Universitaetsklinikum Frankfurt ( Site 1563)

location_facility: Capital & Coast District Health Board - Wellington Hospital ( Site 1101)

location_facility: H. Lee Moffitt Cancer Center and Research Institute ( Site 0024)

location_facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)

location_facility: Severance Hospital Yonsei University Health System ( Site 1001)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0805)

location_facility: Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei ( Site 2501)

location_facility: Institut De Cancerologie De Lorraine ( Site 1409)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0253)

location_facility: MI Odessa Regional Oncological Centre ( Site 2222)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)

location_facility: Thompson Cancer Survival Center ( Site 2812)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)

location_facility: China Medical University Hospital ( Site 0904)

location_facility: Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)

location_facility: Investigacion Onco Farmaceutica S de RL de CV ( Site 0300)

location_facility: Korea University Guro Hospital ( Site 1008)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0254)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107)

location_facility: Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 2002)

location_facility: Bozeman Health Deaconness Cancer Center ( Site 0053)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2227)

location_facility: Chelsea and Westminster Hospital ( Site 1901)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2218)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)

location_facility: National Cheng Kung University Hospital ( Site 0905)

location_facility: Nova Scotia Health Authority ( Site 0103)

location_facility: Clínica Universitaria Reina Fabiola ( Site 0505)

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 1572)

location_facility: West Suffolk Hospitals NHS Trust ( Site 1919)

location_facility: City Clinical Hosp.4 of DCC ( Site 2215)

location_facility: MedStar Franklin Square Medical Center ( Site 0044)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0806)

location_facility: Boca Raton Regional Hospital ( Site 0018)

location_facility: Sanatorio Privado San Geronimo S.R.L ( Site 0510)

location_facility: National Taiwan University Hospital ( Site 0900)

location_facility: Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)

location_facility: Disney Family Cancer Center ( Site 0005)

location_facility: Medical Center Asklepion LLC ( Site 2243)

location_facility: Gyeongsang National University Hospital ( Site 1005)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2224)

location_facility: Western General Hospital, Edinburgh ( Site 1924)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0252)

location_facility: Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 2104)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2226)

location_facility: Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)

location_facility: Klinikum Wuerzburg Mitte gGmbH ( Site 1559)

location_facility: Hospital Universitario Virgen Macarena ( Site 1712)

location_facility: Complejo Hospitalario de Malaga ( Site 1714)

location_facility: Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)

location_facility: Centro Oncológico de Rosario ( Site 0507)

location_facility: Stronach Regional Cancer Centre ( Site 0100)

location_facility: Seoul National University Hospital ( Site 1000)

location_facility: Kingston Health Sciences Centre ( Site 0102)

location_facility: Hospital Britanico de Buenos Aires ( Site 0500)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 1003)

location_facility: Complejo Hospitalario de Jaen ( Site 1713)

location_facility: Central City Clinical Hospital ( Site 2221)

location_facility: Moscow Regional Oncological Dispensary ( Site 2028)

location_facility: Instituto do Cancer do Ceara ( Site 0251)

location_facility: Hospital Italiano de Buenos Aires ( Site 0511)

location_facility: Okayama University Hospital ( Site 0810)

location_facility: Mount Sinai Hospital Medical Center ( Site 0035)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)

status: Active, not recruiting

title: A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

type: Other Identifier

type: Registry Identifier

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
United States
Ukraine
Romania
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation

ipd_sharing: Yes


summary: The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs pembrolizumab plus maintenance pemetrexed for the treatment of nonsquamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)

location_facility: Instituto do Cancer do Ceara ( Site 0201)

location_facility: Birmingham Heartlands Hospital ( Site 1910)

location_facility: Alabama Oncology Bruno Cancer Center ( Site 0001)

location_facility: Aichi Cancer Center Hospital ( Site 0803)

location_facility: Hospital Clinico Lozano Blesa ( Site 1700)

location_facility: Samsun Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2106)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0200)

location_facility: National Cancer Center Hospital East ( Site 0801)

location_facility: SPb Central Clinical Railway Hospital ( Site 2003)

location_facility: Namik Kemal Universitesi Tip Fakultesi ( Site 2100)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2204)

location_facility: Ege Universitesi Tip Fakultesi ( Site 2109)

location_facility: Waverly Hematology Oncology ( Site 0081)

location_facility: Erciyes Universitesi Tip Fakultesi ( Site 2108)

location_facility: Kanazawa University Hospital ( Site 0811)

location_facility: SPb SBHI City Clinical Oncological Dispensary ( Site 2001)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0207)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)

location_facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)

location_facility: Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1523)

location_facility: Central City Clinical Hospital ( Site 2207)

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0604)

location_facility: Osaka International Cancer Institute ( Site 0809)

location_facility: Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)

location_facility: Townsville General Hospital ( Site 1202)

location_facility: MidCentral DHB Palmerston North Hospital ( Site 1102)

location_facility: Hopital d'Instruction des Armees Begin ( Site 1413)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 2211)

location_facility: Hospital Italiano Regional del Sur ( Site 0509)

location_facility: Klinikum Wuerzburg Mitte gGmbH ( Site 1509)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)

location_facility: Instituto Medico Rio Cuarto ( Site 0501)

location_facility: Queen Elizabeth II Health Sciences Centre ( Site 0107)

location_facility: Chungbuk National University Hospital ( Site 1002)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 2209)

location_facility: Mount Sinai Hospital Medical Center ( Site 0032)

location_facility: Saint Gallen Instituto de Oncologia ( Site 0206)

location_facility: Kansai Medical University Hospital ( Site 0804)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)

location_facility: Centre Hospitalier De Chauny ( Site 1411)

location_facility: Regional Centre of Oncology-Thoracic organs ( Site 2205)

location_facility: Universitaetsmedizin Goettingen ( Site 1507)

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 1522)

location_facility: Southern Medical Day Care Centre ( Site 1200)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)

location_facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)

location_facility: MI Odessa Regional Oncological Centre ( Site 2208)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0601)

location_facility: Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site

location_facility: The Cancer Institute Hospital of JFCR ( Site 0800)

location_facility: Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036)

location_facility: Niigata Cancer Center Hospital ( Site 0808)

location_facility: Colchester General Hospital ( Site 1911)

location_facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0903)

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)

location_facility: Social Medical Center - Otto Wagner Hospital ( Site 1301)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2212)

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0209)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)

location_facility: Capital & Coast District Health Board - Wellington Hospital ( Site 1101)

location_facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)

location_facility: City Clinical Hosp.4 of DCC ( Site 2201)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2213)

location_facility: Stronach Regional Cancer Centre ( Site 0101)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0805)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0203)

location_facility: Institut De Cancerologie De Lorraine ( Site 1409)

location_facility: Studienzentrum Aschaffenburg ( Site 1525)

location_facility: Health Sciences North Research Institute ( Site 0115)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)

location_facility: Thompson Cancer Survival Center ( Site 2812)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)

location_facility: China Medical University Hospital ( Site 0904)

location_facility: Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)

location_facility: Korea University Guro Hospital ( Site 1008)

location_facility: Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 2002)

location_facility: Chelsea and Westminster Hospital ( Site 1901)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)

location_facility: National Cheng Kung University Hospital ( Site 0905)

location_facility: Clínica Universitaria Reina Fabiola ( Site 0505)

location_facility: Medstar Good Samaritan Hospital ( Site 0040)

location_facility: West Suffolk Hospitals NHS Trust ( Site 1919)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0204)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 0041)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0806)

location_facility: National Taiwan University Hospital ( Site 0900)

location_facility: Boca Raton Regional Hospital ( Site 0018)

location_facility: Sanatorio Privado San Geronimo S.R.L ( Site 0510)

location_facility: Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)

location_facility: InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1514)

location_facility: Disney Family Cancer Center ( Site 0005)

location_facility: Universitaetsklinikum Frankfurt ( Site 1513)

location_facility: CISSS de la Monteregie-Centre ( Site 0114)

location_facility: Gyeongsang National University Hospital ( Site 1005)

location_facility: Western General Hospital, Edinburgh ( Site 1924)

location_facility: Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 2104)

location_facility: Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0202)

location_facility: Administradora Country S.A. ( Site 0603)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2210)

location_facility: Universitaetsklinikum Regensburg ( Site 1512)

location_facility: University of Tennessee Medical Center Knoxville ( Site 0060)

location_facility: Hospital Clinico Universitario de Valencia ( Site 1706)

location_facility: Medical Center Asklepion LLC ( Site 2234)

location_facility: Centro de Hematologia e Oncologia ( Site 0205)

location_facility: Bozeman Health Deaconness Cancer Center ( Site 0046)

location_facility: Hospital Universitario Quiron Madrid ( Site 1701)

location_facility: Northwest Alabama Cancer Center, PC ( Site 0002)

location_facility: Hospital Universitario Nuestra Senora de Valme ( Site 1703)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0214)

location_facility: Helios Klinikum Erfurt GmbH ( Site 1502)

location_facility: Pneumologische Lehrklinik Universitaet Goettingen ( Site 1501)

location_facility: Columbus Regional Research Institute ( Site 0098)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0105)

location_facility: Centre de Sante et des Services Sociaux de Rimouski-Neigette ( Site 0104)

title: A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Nonsquamous Non-Small-Cell Lung Cancer

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Colombia
United States
Ukraine
Romania
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation


title: A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

ReferenceCitation: Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.

oa_host_type: closed

publisher_dissemination: Informa

lead_sponsor: Hoffmann-La Roche

collaborators: Institut Jules Bordet/Clinical Trials Support Unit (IJB/CTSU)

collaborators: Frontier Science & Technology Research Foundation, Inc.

sponsor_collaborators: Institut Jules Bordet/Clinical Trials Support Unit (IJB/CTSU)

sponsor_collaborators: Frontier Science & Technology Research Foundation, Inc.

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Czechia
France
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
China
Peru
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Hospital Mutua de Terrassa; Servicio de Oncologia

location_facility: University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

location_facility: Hospital General De Catalunya; Servicio de Oncologia

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Klinikum Kreuzschwestern Wels; Iv. Interne Abt.

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

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

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie

location_facility: Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi

location_facility: The 900th Hospital of PLA joint service support force

location_facility: St. Luke's Internat. Hospital, Breast Surgical Oncology

location_facility: Advocate Illinois Masonic Outpatient Center for Advanced Care

location_facility: John Muir Health Clinical Research Center

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz

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

location_facility: Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University

location_facility: Beijing Hospital; Internal Medicine-Oncology

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Austin Hospital Olivia Newton John Cancer Centre

location_facility: Hadassah Med Org Kiryat; Oncology Institute

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

location_facility: Sumy Reg. Clin. Oncological Dispensary; Thoracall Department

location_facility: Ospedale Santa Maria Annunziata; Oncologia

location_facility: CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO

location_facility: Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Medical University Innsbruck; Frauenklinik Innsbruck, Dept Gyn

location_facility: Hirslanden Medical Center - Tumorzentrum

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Transkarpathian Regional Oncology Clinic; Chemotherapy

location_facility: Harbin Medical University Cancer Hospital

location_facility: Ege Universitesi Hastanesi (Saglik Uygulama ve Arastirma Merkezi)

location_facility: Icon Cancer Foundation; Icon Cancer Care Chermside

location_facility: Izmir Ekonomi Universitesi Medical Park Hastanesi

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Severance Hospital; Yonsei University Health System

location_facility: Icon Cancer Foundation; Icon Cancer Care Southport

location_facility: General Hospital Hietzing, KLI; Dept. Obstet&Gynecol

location_facility: Calderdale and Huddersfield NHS Foundation Trust

location_facility: Mackay Memorial Hospital - Taipei Branch

location_facility: King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University

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

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie

location_facility: Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard

location_facility: NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: Nemocnice Horovice, NH Hospital a.s.; Oncology Department

location_facility: Siriraj Hospital; Clinical Research Center, Pharmacy Department

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Box Hill Hospital; Eastern Clinical Research Unit

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Queen Elizabeth Hospital Department of Clinical Oncology

location_facility: Private Healthcare Institution Clinical Hospital RZhD Medicine

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: CCCH City Oncological Center SHEI Uzhgorod NU

location_facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

location_facility: U.O Medicina Oncologica Ospedale di Carpi

location_facility: CH Annecy Genevois site Annecy; Oncologie

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

location_facility: Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

location_facility: E-Da Cancer Hospital; Hematology- Oncology Department

location_facility: Rochester General Hospital; Lipson Cancer and Blood Center

location_facility: LCC Center of Palliative Medicine - Devita

location_facility: Princess Alexandra Hospital; Cancer Trials Unit

location_facility: "Filantropia" Clinical Hospital; Gynecological Oncology

location_facility: CRLCC-Francois Baclesse; Oncologie Médicale

location_facility: The Affiliated Hospital of Medical College Qingdao University

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: National Medical Research Center for Oncology

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Municipal Institution Odesa Regional Oncology Dispensary

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: The First Affiliated Hospital of Xian Jiao Tong University

location_facility: Chi De Cornouaille; Oncologie Hospitalisation

location_facility: Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica

location_facility: Instituto Brasileiro de Controle Do Câncer ? São Camilo Oncologia

location_facility: Centro Integral Oncológico Clara Campal Ensayos Clínicos START

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Municipal Institution Kirovograd Regional Oncology Dispensary

location_facility: Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy; Klinika Onkologii

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: SHI Volgograd Regional Clinical Oncological Dispensary#1

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Sun yat-sen University Cancer Center; Internal Medicine of Oncology

location_facility: Nizhny Novgorod Regional Clinical Oncology Center

location_facility: Intermountain Precision Genomics Cancer Research Clinic-Dixie

location_facility: GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe

location_facility: Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: Des Moines Oncology Research Association

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: BIH at Omsk Region "Clinical Oncology Dispensary", Outpatient clinic

location_facility: Municipal Institution Odesa Regional Clinical Hospital

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Fujian Medical University Union Hospital

location_facility: Hospital Infanta Sofia; Servico de Oncologia

location_facility: Centro Oncologico de Galicia COG; Medical Oncology

location_facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi

location_facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

location_facility: Saitama Medical University International Medical Center

location_facility: University of Maryland Greenebaum Comprehensive Cancer Center

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department

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

location_facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hopital Prive Drome Ardeche; Hopital De Jour

location_facility: Fairview Southdale Medical Oncology Clinic

location_facility: Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

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

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

location_facility: Hospital Universitario de Fuenlabrada; Servicio de Oncologia

location_facility: Albertinen-Krankenhaus Klinik f.Gynäkologie und Geburtshilfe

location_facility: Sun Yat-Sen University Cancer Center - Huangpu Campus

location_facility: CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie

location_facility: National University Hospital; Medical Oncology

location_facility: ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

location_facility: Hospital Universitari Sant Joan de Reus; Planta baja, color lila

location_facility: Regional Oncology Center; Department of Mammology

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: The Second Affiliated Hospital of Zhejiang University College

location_facility: INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology

location_facility: Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología

location_facility: Klinikum der Universität München; Frauenklinik - Onkologie II

location_facility: Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

location_facility: Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

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

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

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

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

location_facility: Beaumont Hospital; Cancer Clinical Trials Unit

location_facility: Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira

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

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

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Seoul National University Bundang Hospital

location_facility: The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Centro de Oncologia e; Investigacion Buenos Aires - COIBA

location_facility: AKH - Medizinische Universität Wien; Department of Oncology

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: Chernivtsi Regional Clinical Oncology Dispensary

location_facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

location_facility: Regional Oncology Dispensary; Dept of Chemotherapy

location_facility: Vinnytsya Regional Clinical Oncology Dispensary

location_facility: Ospedale Degli Infermi - Faenza; Oncologia Medica


title: A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Treated With Gemcitabine Followed by Brentuximab Vedotin Maintenance

summary: This study is an open label, multicenter phase 2 study. The primary objective of the study is to determine the efficacy of brentuximab vedotin in patients treated by gemcitabine for relapsed or refractory peripheral T-cell lymphoma in term of overall response rate assessed after 4 cycles of treatment according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response).

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Centre François Magendie - Hôpital du Haut Lévêque


summary:
The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).

The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution).

location_facility: St. Luke's University Health Network ( Site 3006)

location_facility: McGill University Health Centre ( Site 0113)

location_facility: Taipei Veterans General Hospital ( Site 3301)

location_facility: Banner MD Anderson Cancer Center ( Site 3029)

location_facility: University College London Hospital NHS Foundation Trust ( Site 1806)

location_facility: Hospital Britanico de Buenos Aires ( Site 0204)

location_facility: I.E.U. Medical Point Hastanesi ( Site 2115)

location_facility: Clatterbridge Cancer Center NHS FT ( Site 1800)

location_facility: Universitaetsklinikum Heidelberg. ( Site 1204)

location_facility: A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114)

location_facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2310)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3304)

location_facility: Oxford University Hospitals NHS Foundation Trust ( Site 1812)

location_facility: Royal Brisbane and Women s Hospital ( Site 2502)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2200)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 2306)

location_facility: University of Massachusetts ( Site 0029)

location_facility: Universitaetsklinikum Erlangen ( Site 1209)

location_facility: Mid Florida Hematology and Oncology Center ( Site 0067)

location_facility: Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105)

location_facility: Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 3060)

location_facility: Hospital e Maternidade Celso Pierro ( Site 0313)

location_facility: Trillium Health Partners - Credit Valley Hospital ( Site 0102)

location_facility: Clínica de Oncologia Reichow ( Site 0319)

location_facility: Franciscan Health Indianapolis ( Site 0024)

location_facility: Kingston Health Sciences Centre ( Site 0100)

location_facility: William E. Kahlert Regional Cancer Center ( Site 3031)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1706)

location_facility: Kansai Medical University Hospital ( Site 2808)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 0053)

location_facility: USC Norris Comprehensive Cancer Center ( Site 0007)

location_facility: Social Medical Center - Otto Wagner Hospital ( Site 0801)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 2813)

location_facility: GUZ Lipetsk Regional Oncology Dispensary ( Site 2010)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 2304)

location_facility: Vanderbilt University Medical Center ( Site 0075)

location_facility: Medical Center Asklepion LLC ( Site 2208)

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402)

location_facility: Meander Medisch Centrum-Studie Team Oncologie ( Site 1403)

location_facility: Niigata Cancer Center Hospital ( Site 2801)

location_facility: H. Lee Moffitt Cancer Center and Research Institute ( Site 0016)

location_facility: Veterans Affairs Palo Alto Health Care System ( Site 3039)

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014)

location_facility: Instituto Medico Especializado Alexander Fleming ( Site 0203)

location_facility: Törökbálinti Tüdőgyógyintézet ( Site 2302)

location_facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0206)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 3012)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036)

location_facility: Institutul Oncologic-Oncologie Medicala ( Site 3202)

location_facility: Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804)

location_facility: Darlington Memorial Hospital NHS Trust ( Site 1810)

location_facility: Mass General / North Shore Center for Outpatient Care ( Site 3040)

location_facility: Ospedale Santissima Annunziata ( Site 1303)

location_facility: National Cancer Center Hospital East ( Site 2800)

location_facility: Amethyst Radiotherapy Center-Oncologie Medicala ( Site 3201)

location_facility: University of Yamanashi Hospital ( Site 2807)

location_facility: Sanford Health Roger Maris Cancer Center ( Site 0079)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 2606)

location_facility: Taipei Medical University Hospital ( Site 3303)

location_facility: Medical institute named after Berezin Sergey ( Site 2009)

location_facility: Hospital Provincial del Centenario ( Site 0205)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0110)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 1802)

location_facility: Hospital Universitario Quiron Madrid ( Site 1601)

location_facility: Kartal Training and Research Hospital ( Site 2102)

location_facility: Institut Regional du Cancer de Montpellier - ICM ( Site 1108)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2116)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2816)

location_facility: Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007)

location_facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404)

location_facility: Sinai Hospital of Baltimore ( Site 3011)

location_facility: Farkasgyepui Tudogyogyintezet ( Site 2313)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203)

location_facility: Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305)

location_facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207)

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1602)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0105)

location_facility: N.N.Blokhin Russian Cancer Research center ( Site 2013)

location_facility: Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114)

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208)

location_facility: Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500)

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0316)

location_facility: Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2205)

location_facility: Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1309)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300)

location_facility: Evangelisches Krankenhaus Hamm gGmbH ( Site 1205)

location_facility: Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1208)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 2301)

location_facility: Universitaetsspital Zuerich ( Site 1700)

location_facility: Port Macquarie Base Hospital ( Site 2500)

location_facility: Hematology-Oncology Associates of CNY ( Site 3055)

location_facility: Seoul National University Hospital ( Site 2600)

location_facility: Orszagos Onkologiai Intezet ( Site 2308)

location_facility: Alaska Oncology and Hematology ( Site 3063)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301)

location_facility: Goshen Center for Cancer Care ( Site 0022)

location_facility: Chungbuk National University Hospital ( Site 2605)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400)

location_facility: Health Sciences North Research Institute ( Site 0107)

location_facility: Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808)

location_facility: Hospital Universitario La Fe ( Site 1603)

location_facility: Mountain States Health Alliance ( Site 3054)

location_facility: Policlinico Agostino Gemelli ( Site 1302)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 2012)

location_facility: UKGM Gießen/Marburg-Medical Clinic V ( Site 1210)

location_facility: University of Missouri Hospital ( Site 3058)

location_facility: Tri-Service General Hospital ( Site 3300)

location_facility: Lehigh Valley Hospital- Cedar Crest ( Site 3005)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000)

location_facility: Centrum Onkologii im. prof. Franciszka ukaszczyka-Ambulatorium Chemioterapii ( Site 2407)

location_facility: Royal Free London NHS Foundation Trust ( Site 1813)

location_facility: Penn State University Milton S. Hershey Medical Center ( Site 0064)

location_facility: Universitaetsklinikum Essen ( Site 1201)

location_facility: Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 2305)

location_facility: Norfolk and Norwich University Foundation NHS Trust ( Site 1805)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403)

location_facility: Erciyes University Medical Faculty ( Site 2109)

location_facility: Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407)

location_facility: Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2311)

location_facility: University of Tsukuba Hospital ( Site 2809)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307)

location_facility: Regional Centre of Oncology-Thoracic organs ( Site 2202)

location_facility: University of Tennessee Medical Center Knoxville ( Site 3010)

location_facility: Helse Bergen HF Haukeland Universitetssykehus ( Site 1502)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0043)

location_facility: Universitatsklinik LKH Innsbruck ( Site 0802)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001)

location_facility: Hacettepe University Medical Faculty ( Site 2100)

location_facility: Osaka International Cancer Institute ( Site 2812)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 1100)

location_facility: Hiroshima University Hospital ( Site 2810)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2803)

location_facility: Keppler Universitatsklinikum ( Site 0806)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 2011)

location_facility: Kobe Minimally Invasive Cancer Center ( Site 2811)

location_facility: University of Kentucky School of Medicine & Hospitals ( Site 0026)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1604)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 2802)

location_facility: Aichi Cancer Center Hospital ( Site 2804)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1207)

location_facility: Ukrainian Center of Tomotherapy ( Site 2206)

title: A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Hungary
Switzerland
United States
Ukraine
Romania
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation


acronym: TD-1473 LTS UC Study

lead_sponsor: Theravance Biopharma

summary: A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157

location_facility: Theravance Biopharma Investigational Site #2

title: A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)

ipd_sharing_description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

location_country:
Germany
Poland
Australia
Japan
Canada
Serbia
France
Portugal
Slovakia
Hungary
United States
Ukraine
Romania
Italy
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Georgia
Israel


lead_sponsor: AstraZeneca

summary:
This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

title: A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation

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

location_country:
Germany
Poland
Australia
Brazil
Japan
Turkey
Canada
France
United States
Belgium
China
Puerto Rico
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Russian Federation
Israel


summary:
The purpose of this study is to assess the safety and efficacy of pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer.

The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_facility: Fujian Provincial Cancer Hospital ( Site 0102)

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0403)

location_facility: Christie NHS Foundation Trust ( Site 0275)

location_facility: Hopital Cardiologique Louis Pradel ( Site 0141)

location_facility: Niigata Cancer Center Hospital ( Site 0019)

location_facility: UT Southwestern Medical Center ( Site 0558)

location_facility: Hospital Clinico San Carlos ( Site 0235)

location_facility: West Cancer Center - East Campus ( Site 0544)

location_facility: Universitaetsklinikum des Saarlandes ( Site 0165)

location_facility: Port Macquarie Base Hospital ( Site 0001)

location_facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0123)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 0318)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0286)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0017)

location_facility: North Middlesex University Hospital NHS Trust ( Site 0291)

location_facility: L'hopital Nord-Ouest - Centre Hospitalier de Villefranche sur Saone ( Site 0149)

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0372)

location_facility: Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0380)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0410)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0244)

location_facility: Leeds Teaching Hospital NHS Trust. St. James University Hospital ( Site 0276)

location_facility: Complejo Hospitalario de Malaga ( Site 0238)

location_facility: CIUSSS de la Mauricie et du Centre du Quebec ( Site 0408)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0110)

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 0613)

location_facility: El Camino Hospital Cancer Center ( Site 0529)

location_facility: Mercy Health-Paducah Medical Oncology and Hematology ( Site 0570)

location_facility: Osaka Habikino Medical Center ( Site 0020)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0602)

location_facility: Blacktown Hospital Western Sydney Local Health District ( Site 0008)

location_facility: Hospital General Universitario de Valencia ( Site 0231)

location_facility: National Medical Research Radiology Centre ( Site 0260)

location_facility: Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0314)

location_facility: Good Samaritan Hospital Corvallis ( Site 0521)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0367)

location_facility: St Georges University Hospitals NHS Foundation Trust. ( Site 0292)

location_facility: Hospital General Universitario de Alicante ( Site 0240)

location_facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0601)

location_facility: Guys and St Thomas NHS Foundation Trust ( Site 0280)

location_facility: Instituto Medico Especializado Alexander Fleming ( Site 0369)

location_facility: Krankenhaus Martha Maria Halle-Doelau ( Site 0166)

location_facility: Kanazawa University Hospital ( Site 0018)

location_facility: Kingston Health Sciences Centre ( Site 0414)

location_facility: The Second Hospital Affiliated to AMU ( Site 0119)

location_facility: Abington Hospital - Asplundh Cancer Center ( Site 0575)

location_facility: First Affiliated Hospital of The Third Military Medical University ( Site 0118)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 0064)

location_facility: Central Clinical Hospital with outpatient Clinic ( Site 0262)

location_facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 0371)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 0142)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0383)

location_facility: Parkland Health & Hospital System ( Site 0576)

location_facility: Moscow Regional Oncological Dispensary ( Site 0274)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0603)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0316)

location_facility: The First Affiliated Hospital Zhejiang University ( Site 0109)

location_facility: Leningrad Regional Oncology Center ( Site 0271)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0382)

location_facility: Fujita Health University Hospital ( Site 0016)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0269)

location_facility: Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 0615)

location_facility: Peking Union Medical College Hospital ( Site 0108)

location_facility: Kansai Medical University Hospital ( Site 0022)

location_facility: The Prince Charles Hospital ( Site 0010)

location_facility: Hamato-Onkologie Hamburg Prof. Laack und Partner ( Site 0161)

location_facility: Wakayama Medical University Hospital ( Site 0025)

location_facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0264)

location_facility: Saint Lukes Cancer Institute ( Site 0541)

location_facility: City Clinical Hospital 1 na. NI. Pirogov ( Site 0270)

location_facility: Hospital Universitario La Paz ( Site 0236)

location_facility: First Pavlov State Medical University of Saint Petersburg-Department of Oncology ( Site 0273)

location_facility: The Third Affiliated Hospital of Harbin Medical University ( Site 0100)

location_facility: Shanghai Pulmonary Hospital ( Site 0101)

location_facility: Shaare Zedek Medical Center-Oncology ( Site 0229)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0310)

location_facility: Centro Oncologico Antofagasta ( Site 0386)

location_facility: Hospital Santa Creu i Sant Pau ( Site 0241)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0267)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0111)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0412)

location_facility: National Cancer Center Hospital ( Site 0026)

location_facility: Shamir Medical Center-Assaf Harofeh ( Site 0227)

location_facility: Ankara Universitesi Tip Fakultesi. ( Site 0317)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0021)

location_facility: Thomas Jefferson University Hospital ( Site 0548)

location_facility: Complejo Hospitalario Universitario A Coruna ( Site 0239)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0312)

location_facility: Severance Hospital Yonsei University Health System ( Site 0063)

location_facility: Zhongshan Hospital Fudan University ( Site 0103)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0237)

location_facility: National Cancer Center Hospital East ( Site 0024)

location_facility: Nottingham City Hospital Campus ( Site 0287)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0015)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0171)

location_facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 0124)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 0272)

location_facility: Hospital Universitario La Fe ( Site 0233)

location_facility: Hopital Cite de la Sante de Laval ( Site 0400)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0293)

location_facility: SAHI Republican Clinical Oncological Dispensary of the MoH of RT ( Site 0261)

location_facility: Southern Medical University Nanfang Hospital ( Site 0121)

location_facility: Cancer Hospital Chinese Academy of Medical Science ( Site 0117)

location_facility: Bradford Hill Centro de Investigaciones Clinicas ( Site 0387)

location_facility: Sanford Health Roger Maris Cancer Center ( Site 0533)

location_facility: Clinica Universidad Catolica del Maule ( Site 0385)

location_facility: Hospital Universitario Miguel Servet ( Site 0242)

location_facility: Chungbuk National University Hospital ( Site 0062)

location_facility: Ege Universitesi Tip Fakultesi ( Site 0313)

title: A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)

location_country:
Germany
Poland
New Zealand
Israel
Argentina
United Kingdom
Australia
Japan
United States
China
Korea, Republic of
Spain
Turkey
Chile
Canada
Russian Federation
France


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (LUCERNE)

summary: This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

ReferenceCitation: Khanani AM, Guymer RH, Basu K, Boston H, Heier JS, Korobelnik JF, Kotecha A, Lin H, Silverman D, Swaminathan B, Willis JR, Yoon YH, Quezada-Ruiz C. TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2021 Nov 17;1(4):100076. doi: 10.1016/j.xops.2021.100076. eCollection 2021 Dec.

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories_concat: PubMed Central;oskar-bordeaux.fr

ReferenceCitation: Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.

oa_host_type: repository

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

version: acceptedVersion

unpaywall_oa_status: green

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
France
Portugal
Hungary
Hong Kong
Denmark
United States
China
Italy
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Specialized Hospital for Active Treatment of Eye Diseases Zora

location_facility: Queen Mary Hospital; Department of Ophthalmology

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

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

location_facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

location_facility: "Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch

location_facility: Daping Hospital of Third Military Medical University

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

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

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

location_facility: Eye Hospital, Wenzhou Medical University

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: Hospital de Braga; Servico de Oftalmologia

location_facility: VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

location_facility: The Second Affiliated Hospital of Harbin Medical University; ophthalmology department

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: Centre Ophtalmologique; Imagerie et laser

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Southwest Hospital , Third Military Medical University; Ophthalmology

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Hospital Universitario Miguel Servet; Servicio de Oftalmologia

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: University Retina and Macula Associates, PC

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: Seoul National University Bundang Hospital

location_facility: "Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

location_facility: Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning

location_facility: The Ohio State University Havener Eye Institute

location_facility: Gazi University Faculty of Medicine; Department Of Ophthalmology

location_facility: Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: Northern California Retina Vitreous Associates

location_facility: Southeastern Retina Associates Chattanooga

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: National University Hospital; Ophthalmology Department

location_facility: The Affiliated Eye Hospital of Nanjing Medical University

location_facility: The Second Hospital of Jilin University; ophthalmology department

location_facility: Hospital de Sao Joao; Servico de Oftalmologia

location_facility: Zhongshan Ophthalmic Center, Sun Yat-sen University

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály

location_facility: Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia

location_facility: Pentagram Eye Hospital (Medical Center "Pentagram")

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: Centre Odeon; Exploration Ophtalmologique


acronym: AMALEE

summary:
QT interval prolongation and neutropenia are considered to be important identified risks for ribociclib. The approved dosing regimen of ribociclib is 600 mg daily (QD) on a 3 weeks on/1 week off schedule.

The purpose of the study is to explore whether a reduced dosing regimen of 400 mg ribociclib orally QD 3 weeks on/1 week off may decrease the risk of QTc prolongation without compromising the efficacy of ribociclib in combination with an NSAI in pre- and postmenopausal women with HR-positive, HER2-negative aBC who have received no prior therapy for advanced disease. The risks of other AEs of special interest, such as neutropenia and hepatobiliary toxicity will be evaluated in this study as well.

Approximately 350 patients will be randomly assigned to one of the below treatment arms in a 1:1 ratio: Experimental arm (Arm 1) - Ribociclib 400 mg QD 3 weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Control arm (Arm 2) - Ribociclib 600 mg QD 3 weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Randomization will be stratified by the presence of lung and/or liver metastases (yes versus no).

location_facility: Northwest Medical Specialties Dept.ofNW Med. Specialties

location_facility: Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)

location_facility: Weinberg Cancer Institute at Franklin Square Hospital

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)

location_facility: Nebraska Cancer Specialists Oncology Hematology West

location_facility: Mount Sinai School of Medicine CFTY720D2306

title: A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Finland
Germany
Argentina
Brazil
Costa Rica
Thailand
Czechia
Canada
France
Lithuania
Colombia
Portugal
Hungary
United States
India
Belgium
Peru
Austria
South Africa
Jordan
Bulgaria
Russian Federation
Sweden


title: A Randomized Double-blind Placebo-controlled Multicenter Phase 3 Study of Efficacy and Safety of AR-301 as Adjunct Therapy to Antibiotics in the Treatment of Ventilator-Associated Pneumonia (VAP) Caused by S. Aureus

summary: AR-301 is being evaluated as an adjunctive treatment of ventilator-associated pneumonia (VAP) due to Staphylococcus aureus (S. aureus) in combination with standard of care (SOC) antibiotic therapy in patients with confirmed S. aureus infection.

lead_sponsor: Aridis Pharmaceuticals, Inc.

location_country:
Belarus
Israel
Brazil
Mexico
Belgium
China
Latvia
Georgia
South Africa
Spain
Turkey
Ukraine
Estonia
Russian Federation
France


title: A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients With p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination With Avelumab in MCC Patients Who Are Anti-PD-1 or Anti-PD-L1 Treatment Naïve

summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy or in combination with avelumab in MCC patients who are anti-PD-1 or anti-PD-L1 treatment naïve. Inhibition of MDM2 is a novel mechanism of action in MCC.

lead_sponsor: Kartos Therapeutics, Inc.

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

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Centro Catarinense de Pesquisa (CECAP) - Hospital Santa Catarina de Blumenau

location_facility: Institute for Cancer Research and Treatment

location_facility: Fundacio Investigao Hospital General Universitario de Valencia

location_facility: Hôpital de la Timone. Aix-Marseille Université

location_facility: Nationales Centrum für Tumorerkrankungen NCT

location_facility: Vivantes Network for Health Gmb, Neukölln Clinic

location_facility: Hospital General Universitario Gregorio Marañn (Madrid)

location_facility: Severance Hospital Yonsei University Health System

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale


title: Phase 3 Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Reltecimod as Compared to Placebo in Addition to Standard of Care in Patients With Sepsis-associated Acute Kidney Injury (SA-AKI)

summary: Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.

lead_sponsor: Atox Bio Ltd

location_country:
United States
France

location_facility: University of Minnesota Medical Center-Fairview

location_facility: University of California, Davis Medical Center

location_facility: Erie County Medical Center-Affliate of SUNYat Buffalo

location_facility: University of Texas Health Science Center at San Antonio

location_facility: University of Arkansas for Medical Sciences

location_facility: The Pennsylvania State University and The Milton S. Hershey Medical Center

location_facility: University of Cincinnati Medical Center (UCMC)


acronym: RHEA

summary: A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

location_facility: Theravance Biopharma Investigational Site #2

location_facility: Theravance Biopharma Investigational Site (2)

title: A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis


acronym: AGENT

lead_sponsor: Isofol Medical AB

summary: This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

location_facility: 276-12 - Charité - Universitätsmedizin Berlin

location_facility: 276-02 - Universitätsklinikum Carl Gustav Carus

location_facility: 840-13 - UCH-MHS d/b/a Memorial Health System

location_facility: 124-04 - CISSS de l'Outaouais - Hôpital de Gatineau

location_facility: 392-01 - National Cancer Center Hospital East

location_facility: 392-11 - National Hospital Organization Osaka National Hospital

location_facility: 724-06 - Hospital Universitario Reina Sofia

location_facility: 392-09 - National Hospital Organization Shikoku Cancer Center

location_facility: 840-14 - University of Michigan Cancer Center

location_facility: 840-30 - Joliet Oncology-Hematology Associates

location_facility: 840-04 - St. Vincent Frontier Cancer Center

location_facility: 724-01 - Vall d'Hebron Institute of Oncology

location_facility: 840-27 - Charleston Hematology Oncology Associates

location_facility: 276-04 - MVZ Mitte - Onkologische Schwerpunktpraxis

location_facility: 724-07 - Hospital del la Santa Creu i Sant Pau

location_facility: 840-19 - University of Louisville Research Foundation Inc. (ULRF)

location_facility: 124-01 - Montreal University Health Center

location_facility: 724-05 - Hospital Universitario Virgen del Rocío

location_facility: 840-34 - Banner MD Anderson Cancer Center

location_facility: 250-06 - Centre Georges Francois Leclerc

location_facility: 276-01 - Klinikum der Universität München - Campus Grosshadern

location_facility: 036-09 - Southern Medical Day Care Center

location_facility: 840-02 - The University of Texas Health Science Center

location_facility: 840-29 - Ashland-Bellefonte Cancer Center

location_facility: 124-03 - William Osler Health System - Brampton Civi Hospital

location_facility: 036-04 - Peninsula Health - Frankston Hospital

location_facility: 300-06 - University General Hospital of Larissa

location_facility: 036-01 - Western Health - Sunshine Hospital

location_facility: 036-07 - Northern Health - Epping Hospital

location_facility: 276-10 - Universitärers Cancer Center Hamburg (UCCH)

location_facility: 840-22 - University of Oklahoma Stephenson Cancer Center

location_facility: 124-10 - Thunder Bay Regional Health Research Institute

location_facility: 724-02 - Hospital Regional Universitario Carlos Haya

location_facility: 392-08 - St.Marianna University School of Medicine Hospital

location_facility: 840-15 - University of Southern California

location_facility: 040-01 - Allgemeines Krankenhaus der Stadt Wien

location_facility: 036-10 - Border Medical Oncology Research Unit

location_facility: 724-09 - Hospital Universitario HM Sanchinarro

location_facility: 276-08 - Carl von Basedow Klinikum Saalekrei GmbH

location_facility: 040-06 - Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: 392-12 - Saitama Medical University International Medical Center

location_facility: 250-01 - Institute Hospitalier Franco-Britannique

location_facility: 392-06 - National Cancer Center Hospital

location_facility: 724-03 - Instituto Oncologico Baselga - Hospital Quiron

location_facility: 840-10 - Oregon Health and Science University-Knight Cancer Institute

location_facility: 724-04 - Hospital Unviersitario 12 de Octubre

location_facility: 840-12 - Rutgers Cancer Institute of New Jersey

location_facility: 300-02 - University General Hospital Attikon

location_facility: 276-13 - Universitäres Krebszentrum Leipzig (UCCL)

location_facility: 124-05 - Ottawa Hospital Research Institute

location_facility: 392-14 - Kansai Medical University Hospital

location_facility: 040-02 - Klinikum Klagenfurt am Wörthersee

title: A Randomized, Multicenter, Parallel-group, Phase III Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

location_country:
Germany
Australia
Japan
Sweden
Austria
United States
Spain
Greece
Canada
France


title: A Prospective, Multi-national, Non-interventional Study in Haemophilia A and B Patients With or Without Inhibitors Treated According to Routine Clinical Treatment Practice (Explorer™6)

summary: This study will collect data on bleeds and data related to quality of life in people with severe congenital (a disease existing from birth) haemophilia A and B, with or without inhibitors. The aim for the study is to look at the number of bleeds when on usual treatment for haemophilia. Participants will be asked to keep an electronic diary to track the number of bleeds and the treatment of their bleeds. Participants will be asked to wear an activity tracker on their wrist to capture their level of activity every day for up to 12 weeks. While taking part in this study, participants will keep getting their usual treatment as given to them by their doctor. All study visits at the clinic are done in the same way as the participants are used to. In the time between the participants' visits to the clinic, the study staff at the clinic may call or email the participant. The study will last for about 2½ years.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Germany
Poland
Algeria
Australia
Japan
Bosnia and Herzegovina
Turkey
Croatia
Canada
Serbia
France
Lithuania
Portugal
Slovakia
Hungary
Switzerland
United States
Ukraine
India
Malaysia
Estonia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel

intervention_type: Other