title: An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

summary: The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC).

sponsor_collaborators:
Gilead Sciences
Merck Sharp & Dohme LLC

location_country:
Germany
Italy
United Kingdom
Hong Kong
Australia
United States
Korea, Republic of
Spain
Malaysia
Taiwan
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kansas City Veterans Affairs Medical Center

location_facility: Hospital Regional Universitario de Malaga-Hospital Civil

location_facility: Asklepios Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirugie

location_facility: Seoul Metropolitan Government - Seoul National University Boramae Medical Center

location_facility: AOU Policlinico Vittorio Emanuele - POG Rodolico

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Wake Forest Baptist Health - High Point Medical Center

location_facility: Weill Cornell Medical/New York-Presbyterian Hospital

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: University Hospital Cleveland Medical Center

location_facility: Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie und Pneumologie

location_facility: Martha-Maria Krankenhaus Halle Dölau gGmbH

location_facility: Sunshine Coast University Private Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

location_facility: Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

location_facility: Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: IRCCS Istituti Fisioterapicic Ospitalieri - Istituto Nazionale Tumori Regina Elena

location_facility: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela CHUS_Hospital Clinico Universitario

location_facility: Northside Hospital Central Research Department

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: Clinica Universidad de Navarra - Pamplona

location_facility: Evangelische Lungenklinik Berlin Krakenhausbetriebs GmBH

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

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Universitatsklinikum Koln, Klinik I fur Innere Medizin

location_facility: Centre Jean Perrin - 58 rue Montalembert

location_facility: Siouxland Regional Cancer Center dba June E. Nylen Cancer Center


type: EudraCT Number

type: Registry Identifier

title: A Phase 2, Open-label, Randomized Controlled Trial of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer

summary: The purpose of this study is to assess the safety, efficacy, tolerability, and toxicity of docetaxel alone, in combination with BMS-986218, or in combination with nivolumab plus BMS-986218 in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy and have not received chemotherapy for mCRPC.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United Kingdom
Argentina
Netherlands
United States
Greece
Canada
France

location_facility: Rocky Mountain Cancer Centers - Littleton

location_facility: Columbia University Medical Center - Herbert Irving Pavilion Location

location_facility: Washington University School of Medicine in St. Louis

location_facility: The University of Chicago Medical Center - Duchossois Center for Advanced Medicine

location_facility: Oncology Hematology Care, Inc. - Eastgate

location_facility: Arizona Oncology - Tucson - Wilmot Road Location

location_facility: Texas Oncology-Beaumont Mamie McFaddin Ward Cancer Center

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer Center

location_facility: Texas Oncology - Fort Worth Cancer Center

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Medical Oncology Hematology Consultants - Newark

location_facility: The Winship Cancer Institute of Emory University

location_facility: University Of Iowa Hospitals And Clinics

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

acronym: CONCLUDE

summary: The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.

status: Terminated

ipd_sharing: No

lead_sponsor: InDex Pharmaceuticals

location_country:
Germany
Poland
Australia
Brazil
Bosnia and Herzegovina
Turkey
Croatia
Canada
Serbia
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
United States
Romania
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Georgia
Israel

location_facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy

location_facility: Accellacare Warwickshire Quality Research Site

location_facility: County Durham and Darlington NHS Foundation Trust (CDDFT) - Darlington Memorial Hospital

location_facility: Twoja Przychodnia - Opolskie Centrum Medyczne

location_facility: Kyung Hee University Hospital - Internal Medicine

location_facility: I.V.A.M. Clinical & Investigational Center LLC

location_facility: Klinikum der Johann Wolfgang Goethe-Universität - Medizinische Klinik I

location_facility: Clinical Center Kragujevac - Center for Gastroenterohepatology

location_facility: CHRU Montpellier-Hopital Saint Eloi - Hepato-gastro-enterologie

location_facility: Centro Hospitalar de Entre o Douro e Vouga (CHEDV)- Hospital São Sebastião

location_facility: Carolina Digestive Health Associates, PA

location_facility: University Clinical Centre of the Republic of Srpska - Gastroenterology

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

location_facility: Ufrj - Hospital Universitario Clementino Fraga Filho

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

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clinicos

location_facility: RecioMed Clinical Research Network, Inc.

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata (P

location_facility: Vilniaus Universiteto ligonines Santariskiu Klinikos

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Digestive Health Associates of Texas, PA

location_facility: CHU de Nice - Hôpital de l'Archet II - Gastro-Entérologie, Hépatologie

location_facility: Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi

location_facility: Baylor College of Medicine - Gastroeneterology

location_facility: Centro Regiomontano de Estudios Clinicos Roma SC

location_facility: Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Universita degli Studi dell'Insubria - Ospedale di Circolo e

location_facility: Policlinico Universitario Campus Biomedico

location_facility: Clinical Hospital Center "Dr. Dragisa Misovic"

location_facility: Ålesund Hospital, Møre & Romsdal Hospital trust, Dept. of Medicine, div of Gastroenterology and the Clinical research unit HMR

location_facility: Hacettepe University Medical Faculty - Hematology

location_facility: CHU Amiens - Hopital Sud - Service Hepato-Gastroenterolog

location_facility: Clinical Center University of Sarajevo - Gastroenterology

location_facility: Northern Care Alliance NHS Foundation Trust-Fairfield General Hospital - Gastroenterology

location_facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-

location_facility: CHU de Saint Etienne, Hôpital Nord - Service de Gastroentérologie

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Universitetssykehuset Nord-Norge Tromsø, Gastrolab, Medisinsk poliklinikk, B8

location_facility: Gastroenterology Outpatient Clinic Prof. Dr. med. Ehehalt

location_facility: Karolinska Universitetssjukhuset - Gastroenterology

location_facility: Accellacare Limited/Accellacare of South London

location_facility: Seoul National University Bundang Hospital

location_facility: Clinical Research Solution: Digestive Health Associates

location_facility: Clinexpert Egészségügyi Szolgáltató És Kereskedelmi Kft.

location_facility: General Hospital "Prim.dr.Abdulah Nakas"

location_facility: Charité - Universitätsmedizin Berlin KöR

location_facility: Yonsei University, Wonju Severance Christian Hospital

location_facility: Alliance Clinical Research - Gastroenterology

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

location_facility: Galilee Medical Center (Western Galilee Hospital)

location_facility: Gastroenterology Associates of Northern Virginia

location_facility: Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca

location_facility: Klinika Badawcza Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Medical Professionals Clinical Research Center

location_facility: ASST Papa Giovanni XXIII - Cardiologia - Bergamo

location_facility: Hospital Prof. Doutor Fernando Fonseca (HFF) (Hospital Amadora Sintra)

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika

location_facility: LTD Israel-Georgian Medical Research Clinic Helsicore

location_facility: GASTROMED Kopoń, Zmudziński i Wspólnicy spółka jawna, Specjalistyczne Centrum Gastrologii i Endoskopii, Specjalistyczne Gabinety Lekarskie

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Universita degli Studi di Firenze - Azienda Ospedaliero - Un

status_simplified: Unknown


title: An Interventional, Phase III, Double-blind, Randomized, Controlled, Parallel-group, Multi-site, Clinical Trial Evaluating the Efficacy and Safety of Qutenza® in Subjects With Post-surgical Neuropathic Pain

summary: This is an interventional, Phase III, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated topical application of Qutenza (capsaicin 8% topical system) versus low-dose capsaicin control (capsaicin 0.04% topical system) in subjects with moderate to severe postsurgical neuropathic pain (PSNP).

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Averitas Pharma, Inc.

location_country:
Poland
United Kingdom
Netherlands
United States
Spain
France

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: University Clinical Research - DeLand Clinical Research Unit

location_facility: MeDiNova South London Quality Research Site

location_facility: Leeds General Infirmary - Leeds Teaching Hospitals NHS Trust

location_facility: Centre Regional De Lutte Contre Le Cancer (Crlcc) -Centre Paul Papin

location_facility: Hospital General Universitario de Alicante

location_facility: Centre Hospitalier Departemental Vendee - Centre d'evaluation et de Traitement de la Douleur

location_facility: Accellacare - (MeDiNova Limited) - Northamptonshire

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Cochin Hospital-Paris Descartes University

location_facility: Accellacare - (MeDiNova Limited) - North London

location_facility: International Spine, Pain, and Performance Center

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: Aberdeen Royal Infirmary (ARI) - NHS Grampian

location_facility: Accellacare - (MeDiNova Limited) - Yorkshire

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez

status_simplified: Ongoing


intervention_type: Other

lead_sponsor: Novartis Pharmaceuticals

summary: This is a phase III study of efficacy and safety of secukinumab versus placebo, in combination with glucocorticoid taper regimen, in patients with giant cell arteritis (GCA)

title: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Investigate the Efficacy and Safety of Secukinumab 300 mg and 150 mg Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA) (GCAptAIN)

source: euctr

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

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Estonia
Italy
Guatemala
Norway
United Kingdom
Sweden
Austria
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel

ipd_sharing: Yes


title: Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines With AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Two Monovalent and One Bivalent)

summary:
The primary objectives of the study are:

To assess the safety profile of the study vaccines in each study intervention group.

To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults.

To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster.

The secondary objectives of the study are:

To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study.

To assess the neutralizing and binding antibody responses of booster vaccination.

To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination.

To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.

status: Active, not recruiting

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Sridhar S, Joaquin A, Bonaparte MI, Bueso A, Chabanon AL, Chen A, Chicz RM, Diemert D, Essink BJ, Fu B, Grunenberg NA, Janosczyk H, Keefer MC, Rivera M DM, Meng Y, Michael NL, Munsiff SS, Ogbuagu O, Raabe VN, Severance R, Rivas E, Romanyak N, Rouphael NG, Schuerman L, Sher LD, Walsh SR, White J, von Barbier D, de Bruyn G, Canter R, Grillet MH, Keshtkar-Jahromi M, Koutsoukos M, Lopez D, Masotti R, Mendoza S, Moreau C, Ceregido MA, Ramirez S, Said A, Tavares-Da-Silva F, Shi J, Tong T, Treanor J, Diazgranados CA, Savarino S. Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study. Lancet Infect Dis. 2022 May;22(5):636-648. doi: 10.1016/S1473-3099(21)00764-7. Epub 2022 Jan 25.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via free pdf)

repository_normalized: medRxiv

version: submittedVersion

repositories:
PubMed Central
medRxiv

repositories_concat: PubMed Central;medRxiv

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi Pasteur, a Sanofi Company

sponsor_collaborators:
Sanofi Pasteur, a Sanofi Company
GlaxoSmithKline

location_country:
New Zealand
United Kingdom
Australia
Mexico
United States
Honduras
Spain
Panama
Kenya
France

location_facility: Chicago Clinical Research Institute, Inc.-Site Number:8400269

location_facility: Synexus - Clinical Research Advantage, Inc.-Site Number:8400271

location_facility: Charles R. Drew University of Medicine and Science-Site Number:8400220

location_facility: Synexus Clinical Research US, Inc. - Orlando-Site Number:8400179

location_facility: Coastal Carolina Research Center-Site Number:8400097

location_facility: Meridian Clinical Research-Site Number:8400030

location_facility: Columbia University Irving Medical Center-Site Number:8400203

location_facility: Optimal Research, LLC Rockville-Site Number:8400048

location_facility: New York University Langone Vaccine Center-Site Number:8400230

location_facility: Optimal Research, LLC-Site Number:8400057

location_facility: Synexus - Clinical Research Advantage, Inc.-Site Number:8400270

location_facility: Black Hills Center for American Indian Health, Inc.-Site Number:8400204

location_facility: University of Rochester-Site Number:8400207

location_facility: Emory University Decatur-Site Number:8400201

location_facility: Optimal Research Texas-Site Number:8400191

location_facility: Baptist Health Center for Clinical Research-Site Number:8400077

location_facility: Research Centers of America-Site Number:8400089

location_facility: The George Washington University-Site Number:8400212

location_facility: Peninsula Research Associates, Inc.-Site Number:8400094

location_facility: Holy Name Medical Center-Site Number:8400072

location_facility: Brigham and Women's Hospital-Site Number:8400199

location_facility: Synexus Clinical Research Evansville-Site Number:8400272

location_facility: University of Pittsburgh-Site Number:8400233

intervention_type: Biological

lead_sponsor_type: academique


title: Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation

acronym: Tailored-AF

summary:
Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI).

The hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.

ReferenceType: background

ReferenceCitation: Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

oa_host_type: repository

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

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

unpaywall_oa_status: green

ReferenceCitation: Seitz J, Durdez TM, Albenque JP, Pisapia A, Gitenay E, Durand C, Monteau J, Moubarak G, Theodore G, Lepillier A, Zhao A, Bremondy M, Maluski A, Cauchemez B, Combes S, Guyomar Y, Heuls S, Thomas O, Penaranda G, Siame S, Appetiti A, Milpied P, Bars C, Kalifa J. Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2022 Nov;33(11):2250-2260. doi: 10.1111/jce.15657. Epub 2022 Sep 18.

lead_sponsor: Volta Medical

collaborators: Covance CardiaBase

sponsor_collaborators:
Volta Medical
Covance
CardiaBase

location_country:
Germany
Netherlands
Belgium
United States
France

location_facility: Hôpital Louis Pradel - Hospices Civils de Lyon

intervention_type: Procedure


title: A Phase 2b/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Clonidine Mucoadhesive Buccal Tablet to Placebo to Prevent Chemoradiotherapy-induced Severe Oral Mucositis in Patients With Oropharyngeal Cancer

acronym: VOICE

summary: This study is being performed to evaluate the effectiveness of a new drug, clonidine HCl MBT, to prevent the onset of severe oral mucositis (SOM) in patients with oropharyngeal cancer (OPC) who are being treated with chemoradiotherapy. OPC occurs on the back of the tongue or throat and is often treated by the use of chemoradiotherapy, where radiation is localized to these areas. Radiation to the OPC affected tissues causes the release of small proteins called cytokines that cause damage to the area surrounding the tumor including the oral cavity. This damage is characterized by the formation of mucositis which includes redness, pain and ulcers in the mouth and back of the throat. In addition, as more chemoradiation is administered to treat OPC, the inability to eat a solid diet (a Grade 3 mucositis) or to consume anything at all by mouth (a Grade 4 mucositis) occurs in many patients. Collectively, Grade 3 and Grade 4 mucositis is referred to as SOM. It is a frequent, debilitating side effect of chemoradiation in OPC that may cause patients to stop or interrupt their treatment, develop other side effects like the inability to swallow, or require the increased use of pain medications. OPC survivors who have successful treatment of their tumors often develop permanent swallowing, speaking and range of motion issues that may be linked back to the inability to eat and/or drink caused by SOM during their chemoradiotherapy treatment. Clonidine may inhibit the production of cytokines that cause SOM and clonidine HCl mucoadhesive buccal tablet (MBT) has been designed to deliver sustained high levels of clonidine in the oral cavity, potentially decreasing cytokine production and leading to a decrease in the incidence of SOM. Clonidine HCl MBT is a once per day treatment provided as a tablet that a patient may self-administer to the gums, where it sticks tightly to release clonidine over many hours. The primary objective of this Phase 2b/3 study is to evaluate whether clonidine HCl MBT is more effective than placebo MBT in decreasing the incidence of SOM.

primary_purpose: Supportive Care

lead_sponsor: Monopar Therapeutics

location_country:
Germany
United States
Spain
Puerto Rico
France

location_facility: Centre Hospitalier Universitaire Amiens-Picardie

location_facility: Centre hopitalier intercommunal de Créteil

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Novant Health Cancer Institute - Forsyth

location_facility: Mary Hillman Radiation Oncology Center at UPMC Shadyside

location_facility: Centre Hospitalier Universitaire Morvan / Centre Hospitalier Universitaire de Brest

location_facility: Institut Andree Dutreix / Centre de Cancerologie Dunkerque

location_facility: HSHS St. Vincent Hospital Cancer Centers at HSHS St. Vincent Hospital

location_facility: Hospital Clínico Universitario Santiago de Compostela

location_facility: Louisiana State University Health - Shreveport

location_facility: Institut Català d'Oncologia Hospitalet (Hospital Duran i Reynals)

location_facility: Hospital Complejo Universitario de Navarra

location_facility: Caritas Klinikum Saarbrucken St. Theresia

location_facility: Centre Hospitalier Universitaire La miletrie

location_facility: University of North Carolina at Chapel Hill

location_facility: University of Arkansas for Medical Sciences

location_facility: Des Moines Oncology Research Association

location_facility: AHN Cancer Institute - Allegheny General

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Benaroya Research Institute at Virginia Mason


lead_sponsor: Hoffmann-La Roche

summary: This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

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

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Ryazan Regional clinical oncology dispensary

location_facility: Centre Alexis Vautrin; Oncologie Medicale

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

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: 19 Mayis University Medical Faculty; Medical Oncology Department

location_facility: Leicester Royal Infirmary; Infectious Disease Unit

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Podolsk City Clinical Hospital; Hematology

location_facility: Katip Celebi University Ataturk Training and Research Hospital; Oncology

location_facility: Budapesti Uzsoki Utcai Kórház; Onkoradiológiai Osztály

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: University of Miami; Dept Sylvester Cancer Center

location_facility: the First Affiliated Hospital of Bengbu Medical College

location_facility: Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology

location_facility: CENTRE HOSPITALIER EMILE ROUX; ONCOLOGIE et CHIMIOTHERAPIE

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Affiliated Hospital of Hebei University; Department of medical oncology

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Sociedad de Metabolismo y Corazón (SOMECO)

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Instituto Peruano de Oncología y Radioterapia

location_facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: Centre Hospitalier de l?Université de Montréal (CHUM)

location_facility: Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik

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

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

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Universite de Montreal - Hopital Maisonneuve-Rosemont

location_facility: Fujian Medical University Union Hospital

location_facility: Princess Alexandra Hospital; Division of Cancer Services

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

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

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: CHD DE VENDEE; Unité de Recherche Clinique Onco-Hematologie

location_facility: Kaiser Permanente - Moanalua Medical Center

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

location_facility: Fiona Stanley Hospital - Medical Oncology

location_facility: Centre Hospitalier de La Cote Basque; Oncologie

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

location_facility: National Hospital Organization Kyushu Cancer Center

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

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Shengjing Hospital of China Medical University

location_facility: Mackay Memorial Hospital; Dept of Surgery

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

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

location_facility: China Medical University Hospital; Surgery

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Kyungpook National University Medical Center

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

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

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

location_facility: Rajavithi Hospital; Division of Medical Oncology

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

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

location_facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona

location_facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Kaiser Permanente - San Leandro Medical Center

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

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Auckland City Hospital; Clinical Oncology

location_facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

location_facility: HM Sanchinarro ? CIOCC; Servicio de Oncologia

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

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

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Medeniyet University Goztepe Training and Research Hospital.

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

location_facility: Seoul National University Bundang Hospital

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Chulalongkorn Hospital, Faculty of Medicine; Dept. of Medicine

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: CEMER Centro Medico de Enfermedades Respiratorias

location_facility: Harbin Medical University Cancer Hospital

location_facility: Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

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

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

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

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

location_facility: Fondazione del Piemonte per l?Oncologia (IRCCS)

location_facility: Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

location_facility: Sjællands Universitetshospital, Næstved; Onkologisk Afdeling

location_facility: Memorial Sloan Kettering Cancer Center at Nassau

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

location_facility: Peterborough City Hospital; Oncology Research Department 018

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

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

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU

location_facility: Maryland Oncology Hematology; Maryland Oncology Hematology, PA

location_facility: Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department

location_facility: The First Affiliated Hospital of Xian Jiao Tong University

location_facility: Humanitas Centro Catanese Di Oncologia; Oncologia Medica

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit

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

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

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Szpital Morski im. PCK; Poradnia Onkologiczna

location_facility: Instituto Regional de Enfermedades Neoplasicas - IREN Norte

location_facility: Memorial Sloan Kettering Cancer Center at Bergen

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

location_facility: Ivano-Frankivsk Regional Oncology Center

location_facility: Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg

location_facility: Medipol University Medical Faculty; Oncology Department

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Velindre Cancer Centre; Clinical Trials Unit

location_facility: Flinders Medical Centre; Medical Oncology

location_facility: Maidstone Hospital; Kent Oncology Centre

title: A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

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 the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
Portugal
Hungary
Hong Kong
Denmark
United States
Ukraine
Belgium
China
Peru
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)

summary: This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).

ReferenceCitation: Ramalingam SS, Thara E, Awad MM, Dowlati A, Haque B, Stinchcombe TE, Dy GK, Spigel DR, Lu S, Iyer Singh N, Tang Y, Teslenko I, Iannotti N. JASPER: Phase 2 trial of first-line niraparib plus pembrolizumab in patients with advanced non-small cell lung cancer. Cancer. 2022 Jan 1;128(1):65-74. doi: 10.1002/cncr.33885. Epub 2021 Sep 3. Erratum In: Cancer. 2023 Oct 13;:

publisher_dissemination: Wiley

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Turkey
Chile
France
Colombia
Hungary
Switzerland
United States
Romania
Belgium
Peru
Italy
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Bulgaria
Russian Federation
Sweden


acronym: NOTUS

lead_sponsor: Sanofi

summary:
Primary Objective:

To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by

Annualized rate of acute moderate or severe COPD exacerbation (AECOPD)

Secondary Objectives:

To evaluate the effect of dupilumab administered every 2 weeks on

Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo
Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ)
Pre-bronchodilator FEV1 over 52 weeks compared to placebo
Lung function assessments
Moderate and severe COPD exacerbations
To evaluate safety and tolerability
To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility: Frontier Clinical Research, LLC-Site Number:8400049

location_facility: Pulmonary Research of Abingdon, LLC-Site Number:8400030

location_facility: Somnos Clinical Research-Site Number:8400016

location_facility: Quality Clinical Research, Inc.-Site Number:8400073

location_facility: Henry Ford Health System-Site Number:8400053

location_facility: Pioneer Research Solutions, Inc.-Site Number:8400070

location_facility: Genesis Clinical Research & Consulting-Site Number:8400050

location_facility: Carolina Medical Research, LLC-Site Number:8400026

location_facility: Prolato Clinical Research Center-Site Number:8400128

location_facility: Montana Medical Research-Site Number:8400019

location_facility: Medical Centre of Conyers-Site Number:8400064

location_facility: Optimed Research, LTD-Site Number:8400082

location_facility: Southeast Lung Associates-Site Number:8400003

location_facility: Florida Institute for Clinical Research-Site Number:8400129

location_facility: David Kavtaradze MD, Inc.-Site Number:8400135

location_facility: Clinical Research of Gastonia-Site Number:8400010

location_facility: Omega Research Consultants, LLC-Site Number:8400021

location_facility: Great Lakes Medical Research-Site Number:8400044

location_facility: Northlake Medical Group-Site Number:8400099

location_facility: Monroe Biomedical Research-Site Number:8400087

location_facility: St. Francis Sleep, Allergy and Lung Institute-Site Number:8400020

location_facility: Innovation Medical Research Center-Site Number:8400114

location_facility: Pulmonary & Sleep Institute, PA - San Antonio-Site Number:8400080

location_facility: Sciences Connections, LLC-Site Number:8400133

location_facility: River Birch Research, LLC-Site Number:8400045

location_facility: Revive Research Institute-Site Number:8400120

location_facility: Avant Research Associates LLC-Site Number:8400118

location_facility: Central Florida Pulmonary Group, PA-Site Number:8400102

location_facility: Southeastern Research Center-Site Number:8400068

location_facility: DCOL Center for Clinical Research-Site Number:8400028

location_facility: Metroplex Pulmonary and Sleep Center-Site Number:8400131

location_facility: Phoenix Medical Research, LLC-Site Number:8400012

location_facility: Finlay Medical Research-Site Number:8400071

location_facility: Qualmedica Research, LLC-Site Number:8400119

location_facility: Clinical Research of Rock Hill-Site Number:8400138

location_facility: Mt. Olympus Medical Research-Site Number:8400115

location_facility: Herman Clinical Research LLC-Site Number:8400078

location_facility: Phoenix Medical Group-Site Number:8400061

location_facility: Clinrx Research, LLC-Site Number:8400069

location_facility: Beautiful Minds Clinical Research Center-Site Number:8400081

location_facility: Clinical Research Partners-Site Number:8400040

location_facility: Central Florida Pulmonary Group, PA-Site Number:8400101

location_facility: Medical Advancement Center of Arizona-Site Number:8400107

location_facility: Toledo Institute of Clinical Research-Site Number:8400024

location_facility: DL Research Solutions Inc-Site Number:8400089

location_facility: Diagnostics Research Group-Site Number:8400038

location_facility: Allergy, Asthma & Sinus Center, S.C.-Site Number:8400088

location_facility: Gwinnett Biomedical Research-Site Number:8400052

location_facility: De La Cruz Research Center, LLC-Site Number:8400075

location_facility: Scottsboro Quick Care Clinic-Site Number:8400116

location_facility: Asthma and Allergy Institute-Site Number:8400022

location_facility: Pulmonary & Sleep Specialists-Site Number:8400136

location_facility: Innovative Clinical Research-Site Number:8400018

location_facility: Columbus Clinical Services-Site Number:8400062

location_facility: Prospective Research Innovations, Inc.-Site Number:8400063

location_facility: Clinical Research of Central PA-Site Number:8400009

location_facility: Coastal Carolina Health Care, P.A.-Site Number:8400025

location_facility: Lake Norman Pulmonary and Sleep Medicine - Mooresville-Site Number:8400006

location_facility: Direct Helpers Medical Center Inc-Site Number:8400079

location_facility: Houston Pulmonary and Sleep Associates-Site Number:8400011

location_facility: Appalachian Clinical Research-Site Number:8400048

location_facility: Pulmonary & Sleep Associates of Jasper PC-Site Number:8400090

location_facility: Family Medical Specialists of Florida, PA-Site Number:8400077

location_facility: Cullman Research Center, LLC-Site Number:8400095

location_facility: Infinity Medical Research-Site Number:8400004

location_facility: Lapis Clinical Research At BlueSkies Family Medicine-Site Number:8400117

location_facility: Jersey City Breathing Center-Site Number:8400137

location_facility: Renaissance Research and Medical Group, Inc-Site Number:8400092

location_facility: Pioneer Clinical Research-Site Number:8400043

location_facility: Allianz Research Institute-Site Number:8400007

location_facility: Coastal Pulmonary And Critical Care-Site Number:8400013

location_facility: Reed Medical Research-Site Number:8400123

location_facility: Helix Biomedics, LLC-Site Number:8400035

location_facility: Vanguard Clinical Research-Site Number:8400047

location_facility: Vytalus Medical Group-Site Number:8400139

location_facility: Clinical Trials Center of Middle Tennessee-Site Number:8400066

location_facility: MultiSpecialty Clinical Research-Site Number:8400110

location_facility: Great Lakes Research Institute-Site Number:8400096

location_facility: Mid Hudson Medical Research PLLC-Site Number:8400037

location_facility: Biopharma Informatic - Cardiff Avenue - PPDS-Site Number:8400055

location_facility: Onsite Clinical Solutions LLC-Site Number:8400042

location_facility: Institute of HealthCare Assessment, Inc.-Site Number:8400015

location_facility: Allergy, Asthma and Clinical Research Center-Site Number:8400127

location_facility: Florida Pulmonary Research Center-Site Number:8400001

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Czechia
Canada
Serbia
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
United States
Latvia
Ukraine
Romania
Belgium
Peru
United Kingdom
Netherlands
Mexico
Spain
Greece
South Africa
Bulgaria
Russian Federation


title: A Phase III, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination With Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment

summary: This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.

ReferenceCitation: Yang Y, Psutka SP, Parikh AB, Li M, Collier K, Miah A, Mori SV, Hinkley M, Tykodi SS, Hall E, Thompson JA, Yin M. Combining immune checkpoint inhibition plus tyrosine kinase inhibition as first and subsequent treatments for metastatic renal cell carcinoma. Cancer Med. 2022 Aug;11(16):3106-3114. doi: 10.1002/cam4.4679. Epub 2022 Mar 18.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). 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).

collaborators: Exelixis Chugai

sponsor_collaborators:
Hoffmann-La Roche
Exelixis
Chugai

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Denmark
Australia
Japan
United States
Korea, Republic of
Spain
Greece
Canada
Russian Federation
France

location_facility: Barts & London School of Med; Medical Oncology

location_facility: SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

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

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

location_facility: Centre Oscar Lambret; Chir Cancerologie General

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Tokyo Women's Medical University Hospital

location_facility: Private Healthcare Institution Clinical Hospital RZhD Medicine

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

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Fondazione del Piemonte per l?Oncologia (IRCCS); Day Hospital Oncologico Multidisciplinare

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

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona

location_facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

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

location_facility: Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii

location_facility: St-Petersburg Regional Oncology Dispensary; Oncology

location_facility: Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

location_facility: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet; Urologie und Kinderurologie

location_facility: Institut Gustave Roussy; Oncologie Medicale

location_facility: Hospital Alvaro Cunqueiro; Servicio de Oncologia

location_facility: Hospital Universitario de Burgos; Oncología

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Pusan National University Yangsan Hospital

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: Azienda Ospedaliera S. Maria - Terni; Oncologia

location_facility: Virginia Cancer Specialists - Gainsville

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Branch of the company "Hadassah Medical LTD"

location_facility: Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica

location_facility: Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: National Medical Research Center for Surgery named after A.V. Vishnevsky

location_facility: Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: A.O.U di Verona Policlinico G.B. Rossi; Centro Ricerche Cliniche

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: A.O. Universitaria Ospedale Consorziale Policlinico Di Bari; U.O. Oncologia Medica Universitaria

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: New York Oncology Hematology,P.C.-Albany

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

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

location_facility: Wojskowy Instytut Medyczny; Klinika Onkologii

location_facility: Athens Medical Center; Dept. of Oncology

location_facility: Uniklinik-Eppendorf; Klinik U Poliklinik F Urologie


title: A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 1)

summary: The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

collaborators: EMD Serono Research & Development Institute, Inc.

location_country:
Finland
Germany
Poland
Argentina
Australia
Bosnia and Herzegovina
Croatia
Czechia
Canada
Serbia
France
Colombia
Hungary
Hong Kong
United States
Ukraine
India
Belgium
Estonia
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Georgia
Russian Federation
Israel

location_facility:
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Research Site 218
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acronym: PACIFIC-STROKE

lead_sponsor: Bayer

summary: The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart travelled to the brain. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

ReferenceCitation: Shoamanesh A, Mundl H, Smith EE, Masjuan J, Milanov I, Hirano T, Agafina A, Campbell B, Caso V, Mas JL, Dong Q, Turcani P, Christensen H, Ferro JM, Veltkamp R, Mikulik R, De Marchis GM, Robinson T, Lemmens R, Stepien A, Greisenegger S, Roine R, Csiba L, Khatri P, Coutinho J, Lindgren AG, Demchuk AM, Colorado P, Kirsch B, Neumann C, Heenan L, Xu L, Connolly SJ, Hart RG; PACIFIC-Stroke Investigators. Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo-controlled, phase 2b trial. Lancet. 2022 Sep 24;400(10357):997-1007. doi: 10.1016/S0140-6736(22)01588-4. Epub 2022 Sep 2.

oa_host_type: closed

repositories_concat: closed

sponsor_collaborators:
Bayer
Population Health Research Institute

location_facility: Alfried Krupp Krankenhaus Rüttenscheid /Neurologie

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: La Fe University and Polytechnic Hospital | Neurology Service - Vascular Unit

location_facility: Hyogo Prefectural Harima-Himeji General Medical Center

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

location_facility: Kobe City Medical Center General Hospital

location_facility: Nemocnice Ceske Budejovice, a.s. Department of kardiologie

location_facility: Glasgow Royal Infirmary | Glasgow Clinical Research Facility

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino

location_facility: Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni

location_facility: Univ.of South Florida College of Medicine

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"

location_facility: Nemocnice na Homolce - Neurology Department

location_facility: Universitätsklinikum der Johann Wolfgang Goethe Universität

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Krankenhaus der Barmherzigen Brüder Eisenstadt

location_facility: Railway clinical hospital on the station Novosibirsk-Glavniy

location_facility: Hospital Clinico Universitario San Carlos | Neurologia

location_facility: Hospital Universitario Arnau de Vilanova de Lleida

location_facility: Hospital Universitario Ramon y Cajal | Neurology Department - Stroke, No-Cardioembolic-Tia

location_facility: Clinical Inter-District Hospital of Vsevolozhsk

location_facility: Klinik Favoriten - Sozialmedizinisches Zentrum Süd

location_facility: Gornoslaskie CM im. Prof. Leszka Gieca SUM w Katowicach

location_facility: Centre Hospitalier Universitaire - Le Kremlin Bicêtre

location_facility: Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky

location_facility: Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme

location_facility: University of Pittsburgh Medical Center Hamot

location_facility: Svet zdravia, a. s. Vseobecna nemocnica Rimavska Sobota

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

location_facility: Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu

location_facility: CHUC - Hospitais da U. Coimbra - Servico de Neurologia

location_facility: First Multiprofile Hospital for Active Treatment Sofia EAD

location_facility: Complejo Hospitalario Universitario de Albacete | Hospital General Universitario - Neurology Department, Stroke Unit

location_facility: Kust, Ommeland en Meetjesland (KOM) Network | AZ Damiaan - Neurology Department

location_facility: Hospital Garcia de Orta | Research Department

location_facility: Eastern Clinical Research Unit - Box Hill

location_facility: Mazowiecki Szpital Specjalistyczny im. dr. Jozefa Psarskiego

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho

location_facility: Hospital Universitario Clinico de Valladolid | Neurology Department

location_facility: Vseobecna nemocnica s poliklinikou Levoca, a.s.

location_facility: Svet zdravia, a.s. Nemocnica s poliklinikou Spisska Nova Ves

location_facility: Acibadem City Clinic Multiprofile Hospital for Active Treatm

location_facility: Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto

location_facility: Hospital de la Santa Creu i Sant Pau | Neurology Department - Stroke, No-Cardioembolic-Tia

location_facility: Sci-Res. Institute of Complex Cardiovascular Disorders

title: Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke

ipd_sharing_description:
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Finland
Germany
Poland
Australia
Japan
Czechia
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Spain
Bulgaria
Russian Federation
Sweden

ipd_sharing: Undecided


acronym: CRISTALLO

summary: This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale [CIRS]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: Royal North Shore Hospital; Haematology Department

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Asl Le-Ospedale "Vito Fazzi";U.O. Ematologia

location_facility: Peter MacCallum Cancer Centre; Department of Haematology

location_facility: Oncology & Hematolgy Associates of SW Va Inc. - Roanoke

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología

location_facility: Canberra Hospital; Haematology Department

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Medical Center of Aurora; Rocky Mountain Cancer Centers

location_facility: Hopital Robert Debre; Hematologie Clinique

location_facility: Hospital de Navarra, Servicio de Hematología

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: Hopital Saint Jean : Pole Santé du Rousillon; Unité de Recherche clinique

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

location_facility: A.O. Universitaria S. Martino Di Genova; Ematologia 1

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia

location_facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

location_facility: Hospital Universitario de Canarias;servicio de Hematologia

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol

location_facility: CHU de Caen, Institut d'Hématologie de Basse-Normandie

title: A Prospective, Open-Label, Multicenter Randomized Phase III Study to Compare The Efficacy and Safety of A Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/Bendamustine and Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL(17P) or TP53 Mutation

type: Other Identifier

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 the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing).

location_country:
Italy
Australia
United States
Spain
France


acronym: A long-term study to assess the safety and efficacy of nemolizumab in subjects with PN

lead_sponsor: Galderma R&D

summary: The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).

location_facility: Galderma I Galderma Investigational Site

location_facility: Galderma Investigational Galderma Investigational Site

title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
Korea, Republic of
Spain
Canada
France


title: An Observational Retrospective Cohort Study of Lenalidomide Monotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) to Generate a Historical Control for Clinical Trial MOR208C203 (RE-MIND)

acronym: RE-MIND

summary: This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)

study_type: Observational

time_perspective: Retrospective

lead_sponsor: MorphoSys AG

location_country:
United States
Italy
Spain
France

location_facility:
MorphoSys Research Site
MorphoSys Research State


acronym: RAGNAR

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Instituto de Investigaciones Metabólicas

location_facility: Intergrated Clinical Oncology Network Pty Ltd (ICON)

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Ospedale Santa Chiara AO Universitaria Pisana

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

location_facility: First affiliated Hospital of Zhejiang University

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

location_facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

location_facility: Grand Hopital de Charleroi, site Notre Dame

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: Third Military Medical University Daping Hospital Cancer Center

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: Medizinische Fakultat Carl Gustav Carus Technische Universitat Dresden

location_facility: Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: National Hospital Organizaiton Shikoku Cancer Center

location_facility: Beijing Luhe Hospital, Capital Medical University

location_facility: Eastern Theater General Hospital, Qinhuai District Medical Area

location_facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

location_facility: Texas Oncology Odessa-West Texas Cancer Center

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

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

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Instituto de Medicina Integral Professor Fernando Figueira

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Flinders Centre for Innovation in Cancer

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

title: A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Australia
Brazil
Japan
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
France


lead_sponsor: Celgene

summary:
A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants:

Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept
Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met
The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase
Transition Phase is defined as one Enrollment visit
Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol

Follow-up Phase includes:

- 42 Day Safety Follow-up Visit

During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting

- Long-term Post-treatment Follow-up (LTPTFU) Phase

Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule

Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study.

The rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill at least 5 years from the first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later.

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

location_facility: The University of Texas - MD Anderson Cancer Center

title: A Phase 3b, Open-label, Single-arm, Rollover Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

ipd_sharing_description:
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

location_country:
Germany
Australia
Japan
Thailand
Turkey
Canada
France
United States
Tunisia
Lebanon
Belgium
China
Malaysia
Italy
United Kingdom
Sweden
Netherlands
Spain
Greece
Taiwan
Bulgaria
Israel


title: A 64-week, Two-arm, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen in Patients With Neovascular Agerelated Macular Degeneration (TALON)

acronym: TALON

summary: The was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with neovascular age related macular degeneration (nAMD) who have not previously received anti- vascular endothelial growth factor (VEGF) treatment.

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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

location_country:
Germany
Argentina
Australia
Czechia
Canada
France
Portugal
Switzerland
United States
Belgium
Malaysia
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Israel


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

summary: The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).

ReferenceType: result

ReferenceCitation: Bril V, Druzdz A, Grosskreutz J, Habib AA, Mantegazza R, Sacconi S, Utsugisawa K, Vissing J, Vu T, Boehnlein M, Bozorg A, Gayfieva M, Greve B, Woltering F, Kaminski HJ; MG0003 study team. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023 May;22(5):383-394. doi: 10.1016/S1474-4422(23)00077-7. Erratum In: Lancet Neurol. 2023 Oct;22(10):e11.

ReferenceCitation: Bril V, Benatar M, Andersen H, Vissing J, Brock M, Greve B, Kiessling P, Woltering F, Griffin L, Van den Bergh P; MG0002 Investigators. Efficacy and Safety of Rozanolixizumab in Moderate to Severe Generalized Myasthenia Gravis: A Phase 2 Randomized Control Trial. Neurology. 2021 Feb 9;96(6):e853-e865. doi: 10.1212/WNL.0000000000011108. Epub 2020 Nov 20.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)
archive.ugent.be

unpaywall_oa_status: hybrid

publisher_dissemination: Wolters Kluwer Health

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Japan
Belgium
United States
Spain
Taiwan
Czechia
Canada
Georgia
Serbia
Russian Federation
France


title: A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

acronym: IXchange

summary: The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis (MPA).

lead_sponsor: InflaRx GmbH

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Switzerland
Belgium
Spain
Czechia
Russian Federation
France

location_facility:
Clinical site
Clinical Site


lead_sponsor: AstraZeneca

summary: A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

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
Thailand
Vietnam
Turkey
Canada
France
Hong Kong
United States
India
China
Peru
Puerto Rico
Philippines
Egypt
Italy
Singapore
Austria
Korea, Republic of
Taiwan
Russian Federation


title: A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

summary: This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.

design_allocation: Non-Randomized

lead_sponsor: Exelixis

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
Belgium
United States
Spain
Czechia
France

location_facility:
Exelixis Clinical Site #29
Exelixis Clinical Site #21
Exelixis Clinical Site #16
Exelixis Clinical Site #1
Exelixis Clinical Site #69
Exelixis Clinical Site #80
Exelixis Clinical Site #39
Exelixis Clinical Site #12
Exelixis Clinical #75
Exelixis Clinical Site #35
Exelixis Clinical Site #25
Exelixis Clinical Site #60
Exelixis Clinical Site #53
Exelixis Clinical Site #64
Exelixis Clinical #76
Exelixis Clinical Site #56
Exelixis Clinical Site #4
Exelixis Clinical Site #30
Exelixis Clinical Site #27
Exelixis Clinical Site #50
Exelixis Clinical Site #2
Exelixis Clinical #73
Exelixis Clinical Site #34
Exelixis Clinical Site #38
Exelixis Clinical Site #26
Exelixis Clinical Site #8
Exelixis Clinical Site #62
Exelixis Clinical #77
Exelixis Clinical Site #13
Exelixis Clinical Site #45
Exelixis Clinical Site #32
Exelixis Clinical Site #55
Exelixis Clinical Site #10
Exelixis Clinical Site #36
Exelixis Clinical Site #37
Exelixis Clinical Site #33
Exelixis Clinical Site #66
Exelixis Clinical Site #24
Exelixis Clinical Site #65
Exelixis Clinical Site #52
Exelixis Clinical Site #7
Exelixis Clinical Site #51
Exelixis Clinical Site #40
Exelixis Clinical Site #3
Exelixis Clinical Site #83
Exelixis Clinical Site #19
Exelixis Clinical #74
Exelixis Clinical Site #18
Exelixis Clinical Site #14
Exelixis Clinical Site #68
Exelixis Clinical Site #41
Exelixis Clinical Site #44
Exelixis Clinical Site #22
Exelixis Clinical Site #57
Exelixis Clinical Site #23
Exelixis Clinical Site #15
Exelixis Clinical Site #82
Exelixis Clinical Site #6
Exelixis Clinical Site #31
Exelixis Clinical Site #20
Exelixis Clinical Site #46
Exelixis Clinical #70
Exelixis Clinical Site #47
Exelixis Clinical #71
Exelixis Clinical Site #11
Exelixis Clinical Site #54
Exelixis Clinical Site #17
Exelixis Clinical Site #81
Exelixis Clinical Site #58
Exelixis Clinical Site #28
Exelixis Clinical Site #43
Exelixis Clinical Site #48
Exelixis Clinical Site #63
Exelixis Clinical Site #42
Exelixis Clinical Site #49
Exelixis Clinical Site #59
Exelixis Clinical Site #79
Exelixis Clinical #78
Exelixis Clinical Site #9
Exelixis Clinical Site #67
Exelixis Clinical Site #5
Exelixis Clinical Site #61
Exelixis Clinical #72


title: An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies

summary: The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Germany
Italy
Hungary
Argentina
Romania
Australia
Brazil
Japan
United Kingdom
Belgium
United States
Korea, Republic of
Turkey
Czechia
Russian Federation
France

location_facility: Osaka City General Hospital - Dept of Clinical Oncology

location_facility: Osaka Habikino Medical Center - Dept of Pulmonary Oncology

location_facility: Nemocnice Rudolfa a Stefanie Benesov a.s. nemocnice Stredoceskeho kraje - parent

location_facility: Kansas City Research Institute, LLC - Phase I Unit

location_facility: Centre Paul Strauss - Service de Médecine Oncologique

location_facility: Osaka University Hospital - Dept of Gastrointestinal Surgery

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast

location_facility: Centre Antoine Lacassagne - Service d'Hématologie Oncologie

location_facility: CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale

location_facility: Medical University of South Carolina (MUSC)

location_facility: Centre Hospitalier de l'Ardenne - Pharmacie

location_facility: Masarykuv onkologicky ustav - 300176866 Parent

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology

location_facility: CHU Bordeaux - Service d'Oncologie Médicale

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A

location_facility: Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization

location_facility: ICO - Site Paul Papin - service d'oncologie medicale

location_facility: Pavlov First Saint Petersburg State Medical University - PARENT

location_facility: University of California Davis Health System - Comprehensive Cancer Center

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hacettepe University Medical Faculty - Oncology

location_facility: Universitaetsklinikum Essen - Westdeutsches Tumorzentrum

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca - Sectia Radioterapie III

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

location_facility: Hopital Larrey - Service de Pneumologie et Oncologie Thoracique

location_facility: Mersin University Medical Faculty - Medical Oncology

location_facility: CHU Besançon - Hôpital Jean Minjoz - Service d'oncologie Medicale

location_facility: Derriford Hospital - Dept of Oncology Clinical Trials

location_facility: FSBI "National Medical Research Center for Oncology n.a. N.N. Petrov" of the MoH of the RF - Parent

location_facility: Clínica Universitaria Privada Reina Fabiola

location_facility: Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia

location_facility: University of Vermont Medical Center - Fletcher Allen Gastroenterology

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

location_facility: Petz Aladar Egyetemi Oktato Korhaz - Pulmonologiai Osztaly

location_facility: Kurume University Hospital - Dept of Lung Cancer Center

location_facility: National Cancer Center Hospital - Dept of Gastrointestinal Oncology

location_facility: Centre Oscar Lambret - Service d'Oncologie medicale

location_facility: Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty - Medical Oncology

location_facility: ICO - Site René Gauducheau - Service d'Oncologie medicale

location_facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea - Centrul Oncologie Medicala

location_facility: University of Texas Southwestern Medical Center

location_facility: Oncology/Hematology Care Clinical Trials, LLC

location_facility: Norwalk Hospital - The Whittingham Cancer Center

location_facility: Institut Curie - site de Paris - Service d'Oncologie Médicale