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://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country:
Finland
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Chile
Netherlands
Bulgaria
Singapore
Hungary
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Georgia
Spain
Estonia

location_facility:
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Investigational Site Number :6160006
Investigational Site Number :8040004
Investigational Site Number :5280005
Investigational Site Number :2460002
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Investigational Site Number :0360003
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Investigational Site Number :1560001
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Investigational Site Number :3480005
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Investigational Site Number :2760001
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Investigational Site Number :2760002
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Investigational Site Number :3480002
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Investigational Site Number :1240004
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Investigational Site Number :7240005
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Investigational Site Number :3920010
Investigational Site Number :0560001
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Investigational Site Number :3800005
Investigational Site Number :2500001
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Investigational Site Number :7240004
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Investigational Site Number :2030002
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Investigational Site Number :2760005
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Investigational Site Number :4100005
Investigational Site Number :7920001
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Investigational Site Number :0560003
Investigational Site Number :8040001
Investigational Site Number :2460004
Investigational Site Number :7920010
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Investigational Site Number :7920013
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Investigational Site Number :1000003
Investigational Site Number :1560018
Investigational Site Number :6160002
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Investigational Site Number :8400088
Investigational Site Number :6430005
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Investigational Site Number :1560005
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Investigational Site Number :3480009
Investigational Site Number :8260002
Investigational Site Number :3920021
Investigational Site Number :7920002
Investigational Site Number :1560004
Investigational Site Number :1560007
Investigational Site Number :8400052
Investigational Site Number :7920012
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Investigational Site Number :1580001
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Investigational Site Number :0360001
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Investigational Site Number :1580007
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Investigational Site Number :6430009
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Investigational Site Number :3920020
Investigational Site Number :7240007
Investigational Site Number :5280007
Investigational Site Number :2760003
Investigational Site Number :8400013
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Investigational Site Number :6160007
Investigational Site Number :1560048
Investigational Site Number :8400015
Investigational Site Number :8400039
Investigational Site Number :1560019
Investigational Site Number :1560013
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Investigational Site Number :1560027
Investigational Site Number :1560021
Investigational Site Number :0560002
Investigational Site Number :8400005
Investigational Site Number :0760008

title: A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease

summary:
Primary Objective:

To determine whether Amcenestrant (SAR439859) in combination with palbociclib improvesprogression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.

Secondary Objective:

To compare the overall survival in both treatment arms
To evaluate the objective response rate in both treatment arms
To evaluate the duration of response in both treatment arms
To evaluate the clinical benefit rate in both treatment arms
To evaluate progression-free survival on next line of therapy
To evaluate the pharmacokinetics of amcenestrant, and palbociclib
To evaluate health-related quality of life in both treatment arms
To evaluate the time to first chemotherapy in both treatment arms
To evaluate safety in both treatment arms


intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: 4SC AG

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Italy
United States
Switzerland
Netherlands
France
Belgium
Spain
Germany

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Istituto Nazionale Tumori Fondazione G.Pascale

location_facility: UC Irvine Health, Chao Family Comprehensive Cancer Center

location_facility: St. Josef-Hospital Universitätsklinikum Bochum

location_facility: Inova Health System, Inova Schar Cancer Institute

location_facility: Instituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: Ospedale Santa Maria Annunziata via dell'Antella

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck

ipd_sharing: No

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Phase II, Open Label Study to Investigate the Efficacy and Safety of Domatinostat in Combination With Avelumab in Patients With Advanced Unresectable/Metastatic Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 Antibody Therapy

summary: This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic Merkel Cell Carcinoma that have progressed on a previous therapy with an anti-PD-(L)1 antibody

lead_sponsor_type: industriel

status_simplified: Ongoing


design_allocation: Non-Randomized

intervention_type: Biological

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

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
Mexico
Germany
France
Bulgaria
Lithuania
Poland
Romania
Singapore
Australia
Spain
Estonia
Canada
Latvia
Korea, Republic of
Taiwan
Ukraine

acronym: ADjoin

location_facility: Simcoderm Medical & Surgical Dermatology Centre

location_facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie

location_facility: University of South Florida College of Medicine

location_facility: Private Practice - Dr. Ralph von Kiedrowski

location_facility: Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer

location_facility: Institutul National de Diabet Nutritie si Boli Metabolice

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: University of the Sunshine Coast Clinical Trial Centre

location_facility: UOSD Dermatologia Generale ed Oncologica DU, University of

location_facility: California Dermatology & Clinical Research Institute

location_facility: Velocity Clinical Research - Woseth Dermatology

location_facility: Universität Leipzig - Universitätsklinikum

location_facility: International Dermatology Research, Inc.

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: Praxis für Ganzheitliche Dermatologie im Ärztehaus

location_facility: Georgia Pollens Clinical Research Centers, Inc

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

location_facility: Ablon Skin Institute and Research Center

location_facility: Rivergate Dermatology Clinical Research Center PL

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

location_facility: JSC "Center for Diagnosis and Treatment of Allergic Diseases"

location_facility: Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council

location_facility: Children's Hospital, Affiliate of Vilnius University Hospital Santaros klinikos

location_facility: Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak

location_facility: Kansas Medical Clinic, an Elligo Health Research, Inc.

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii

location_facility: Cabinet Dermatologie Prof Dr Orasan Remus

location_facility: Keck School of Medicine University of Southern California

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Institutul Regional de Gastroenterologie si Hepatologie Prof. dr. Octavian Fodor

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Center For Dermatology Clinical Research, Inc.

location_facility: SE "Institute of Dermatology and Venerology of NAMS of Ukraine"

location_facility: University Hospitals Case Medical Center

location_facility: George Washington University Medical Center

location_facility: Riverchase Dermatology and Cosmetic Surgery

location_facility: Health Center 4, Affiliate Diagnostic Center

location_facility: Clinical Research Center of the Carolinas

location_facility: Hospital General Universitario de Alicante

location_facility: Solutions Through Advanced Research, Inc.

location_facility: Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk

location_facility: Ponderas Academic Hospital- Delta Healthcare SRL

location_facility: Florida Academic Centers Research and Education, LLC

location_facility: California Allergy and Asthma Medical Group + Research Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2

location_facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Rivne Regional Dermatology and Venereology Dispensary

location_facility: Smite Aija - Practice in Dermatology Venereology

location_facility: Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"

location_facility: Treatment-diagnostic center PE "Asclepius"

location_facility: Vital Prospects Clinical Research Institute, P.C.

location_facility: Praxis für Dermatologie,Venerologie,Allergologie Centrovital

location_facility: The Pennsylvania Centre for Dermatology, LLC

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: Dermatology Treatment and Research Center

location_facility: University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology

location_facility: Clinical Research Center of Alabama- Birmingham

location_facility: Northwest Arkansas Clinical Trials Center

ipd_sharing: Yes

type: Other Identifier

title: A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)

summary: This 110-week study is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis.


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 the Sharing of Clinical 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).

lead_sponsor: Hoffmann-La Roche

location_country:
Peru
Finland
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Lithuania
Poland
Argentina
Canada
Korea, Republic of
Chile
Sweden
Netherlands
Singapore
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Spain
Turkey

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: China Medical University Hospital; Neurology

location_facility: Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)

location_facility: University of Mississippi Medical Center

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: Hospital Ruber Internacional; Servicio de Neurología

location_facility: Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn

location_facility: IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria

location_facility: Skånes Universitetssjukhus Malmö, Minneskliniken

location_facility: Chang Gung Memorial Foundation - Linkou - Neurology

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: National University Hospital (NUH); Neuroscience

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Surrey and Borders NHS Foundation Trust; Research and Development Departmant; Abraham Cowley Unit

location_facility: Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit

location_facility: The Cognitive and Research Center of New Jersey

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: California Neuroscience Research Medical Group, Inc

location_facility: Hôpital Avicenne; Centre de Recherche Clinique

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Neurologia

location_facility: Center for Diagnosis and Research on Alzheimer's disease

location_facility: Alzheimer's Research and Treatment Center

location_facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría

location_facility: Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia

location_facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

location_facility: Australian Alzheimer's Research Foundation

location_facility: National Clinical Research Inc.-Richmond

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: National Neuroscience Institute; Neurology

location_facility: City Polyclinic No. 2 of the Department of Healthcare of the City of Moscow

location_facility: Servicio de Neurología Hospital Viamed Montecanal.

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Clinica Universitaria Navarra; Servicio Neurologia

location_facility: National Hospital Organization Hiroshima-Nishi Medical Center

location_facility: Instituto Geriatrico Nuestra Señora de las Nieves

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: The Medical Arts Health Research Group - West Vancouver

location_facility: Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry

location_facility: Semmelweis University; Department of Neurology

location_facility: Medical Corporation Hakuyokai Kashiwado Hospital

location_facility: National Hospital Organization Hizen Psychiatric Medical Center

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Neurological Associates of Long Island, PC

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta

location_facility: Hospital Universitario de Santa Maria; Servicio de Neurología

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

location_facility: Seoul National University Bundang Hospital

location_facility: Vilnius University Hospital Santariskiu Clinics; Neurology

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: Medical corporation Ichiekai Itsuki Hospital

location_facility: MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Queen Elizabeth University Hospital - PPDS

location_facility: Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie

location_facility: Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Ośrodek Badawczo-Naukowo-Dydaktyczny Chorób Otępiennych w Ścinawie

location_facility: Fundación Scherbovsky; General Department

location_facility: Gerontopole; Centre de Recherche clinique

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Hospital General Universitario de Albacete; Servicio de Neurología

location_facility: Chang Gung Memorial Foundation - Kaohsiung - Neurology

location_facility: Hospital Mutua De Terrasa; Servicio de Neurologia

location_facility: Hospital San Pedro; Servicio de Neurología

location_facility: University of Nebraska Medical Center; Dept of Neurological Sciences

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Advanced Memory Research Institute of NJ

location_facility: Senior Sp. Z O.O. Poradnia Psychogeriatryczna

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA

location_facility: Tokyo Bay Advanced Medical and Makuhari Clinic

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Hospital General Universitario de Elche; Servicio de Neurología

location_facility: Hospital Victoria Eugenia; Servico Neurología

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: Policlínica Guipuzcoa; Servicio de Neurología

location_facility: Rijikai Medical Corporation Katayama Medical Clinic

location_facility: Hospital Virgen del Rocío; Servicio de Neurología

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

location_facility: CEN Centro Especializado en Neurociencias

location_facility: Neurology Consultants of Dallas; Research Department

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54

location_facility: Center for Advanced Research & Education

location_facility: Clinica Internacional; Unidad De Investigacion

location_facility: Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych

location_facility: The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre

location_facility: Tokyo Medical and Dental University Hospital

location_facility: National Center of Neurology and Psychiatry

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Instituto de Neurociencias San Agustín S.A.

location_facility: Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica

location_facility: National Center for Geriatrics and Gerontology

location_facility: Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia

location_facility: FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Complejo Asistencial de Zamora; Servicio Psiquiatria

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

location_facility: Hospital Virgen del Puerto. Servicio de Neurología

location_facility: University Southampton NHS Foundation Trust; Wessex Neurologica Centre

location_facility: National Taiwan University Hospital; Neurology

location_facility: Ohio State University; College of Medicine

location_facility: Southern Illinois University, School of Medicine

location_facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze

location_facility: Allied Biomedical Research Institute, Inc

title: An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease

summary: This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.


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 2)

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).

status: Active, not recruiting

design_allocation: Randomized

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

location_country:
Malaysia
Greece
Romania
Russian Federation
Ukraine
India
Spain
France
Poland
Lithuania
Slovakia
Thailand
Norway
Moldova, Republic of
Canada
Slovenia
South Africa
Sweden
Switzerland
Philippines
Bulgaria
Singapore
Puerto Rico
Portugal
Germany
United States
Italy
Brazil
Belarus
Turkey
Latvia

location_facility:
Research Site 357
Research Site 734
Research Site 218
Research Site 177
Research Site 191
Research Site 277
Research Site 331
Research Site 735
Research Site 143
Research Site 562
Research Site 381
Research Site 392
Research Site 344
Research Site 141
Research Site 231
Research Site 721
Research Site 536
Research Site 346
Research Site 151
Research Site 455
Research Site 203
Research Site 307
Research Site 332
Research Site 452
Research Site 723
Research Site 583
Research Site 278
Research Site 217
Research Site 286
Research Site 594
Research Site 511
Research Site 627
Research Site 373
Research Site 600
Research Site 293
Research site 514
Research Site 265
Research Site 345
Research Site 457
Research Site 172
Research Site 387
Research Site 403
Research Site 704
Research Site 621
Research Site 157
Research Site 287
Research Site 540
Research Site 211
Research Site 414
Research Site 625
Research Site 144
Research Site 197
Research SIte 284
Research Site 404
Research Site 142
Research Site 738
Research Site 216
Research Site 714
Research Site 194
Research Site 604
Research Site 338
Research Site 233
Research Site 412
Research Site 751
Research Site 631
Research Site 726
Research Site 443
Research Site 718
Research Site 212
Research Site 551
Research Site 553
Research Site 281
Research Site 571
Research Site 213
Research Site 354
Research Site 356
Research Site 502
Research Site 752
Research Site 533
Research Site 215
Research Site 262
Research Site 712
Research Site 719
Research Site 702
Research Site 456
Research Site 759
Research Site 453
Research Site 219
Research Site 454
Research Site 342
Research Site 383
Research Site 736
Research Site 352
Research Site 746
Research Site 501
Research Site 321
Research Site 232
Research Site 609
Research Site 154
Research Site 176
Research Site 289
Research Site 326
Research Site 552
Research site 105
Research Site 323
Research Site 214
Research Site 633
Research Site 717
Research Site 309
Research Site 358
Research Site 556
Research Site 372
Research Site 705
Research Site 534
Research Site 384
Research Site 175
Research Site 273
Research Site 153
Research Site 152
Research Site 192
Research Site 220
Research Site 599
Research Site 371
Research Site 459
Research Site 791
Research Site 614
Research Site 107
Research Site 178
Research Site 531
Research Site 724
Research Site 182
Research Site 184
Research Site 155
Research site 241
Research Site 276
Research Site 741
Research Site 327
Research Site 543
Research Site 535
Research Site 624
Research Site 537
Research Site 222
Research Site 353
Research Site 728
Research Site 101
Reserach Site 451
Research Site 291
Research Site 391
Research Site 390
Research Site 195
Research Site 388
Research Site 288
Research Site 725
Research Site 181
Research site 483
Research Site 282
Research Site 329
Research Site 343
Research Site 582
Research Site 415
Research Site 263
Research Site 596
Research Site 207
Research Site 337
Research Site 328
Research Site 386
Research Site 314
Research Site 703
Research Site 179
Research Site 351
Research Site 171
Research Site 204
Research Site 623
Research Site 156
Research Site 744
Research Site 742
Research Site 748
Research Site 174
Research Site 711
Reserach Site 268
Research Site 266
Research Site 442
Research Site 340
Research Site 339
Research Site 743
Research Site 413
Research Site 411
Research Site 271
Research Site 359
Research Site 385
Research Site 251
Research Site 159
Research Site 106
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Research Site 145
Research Site 603
Research Site 201
Research site 244
Research Site 173
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Research Site 628
Research Site 737
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Research Site 419
Research Site 445
Research Site 382
Research Site 706
Reserach Site 206
Research Site 482
Research Site 270
Research Site 503
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Research Site 180
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Research Site 417
Research Site 740
Research Site 158
Research Site 283
Research Site 512
Research Site 532
Research Site 221
Reserach Site 275
Reserach Site 267
Research Site 626
Research Site 160
Research Site 261
Research Site 341
Research Site 420
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Research Site 183
Research Site 335
Research Site 324
Research site 243


title: A Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg Over 32 Weeks in Adult Patients With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies - PRELUDE

acronym: PRELUDE

summary: The primary purpose of the proof of concept study is to elucidate the efficacy of secukinumab in the treatment of adult patients with biopsy-proven lichen planus not adequately controlled by topical therapies, and to assess the safety and tolerability over 32 weeks.

enrollment_type: Actual

ipd_sharing: Undecided

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
United States
France


title: A Phase 3 Randomized, Open Label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma

acronym: ITHACA

summary:
Primary Objectives:

Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM)
Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in participants with high-risk SMM

Secondary Objectives:

Safety run-in

To assess overall response rate (ORR)
To assess duration of response (DOR)
To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR)
To assess time to diagnostic (SLiM CRAB) progression or death
To assess time to first-line treatment for multiple myeloma (MM)
To assess the potential immunogenicity of isatuximab
Impact of abnormal cytogenetic subtype

Randomized Phase 3 - Key Secondary Objectives:

To compare between the arms

MRD negativity
Sustained MRD negativity
Second progression-free survival (PFS2)
Overall survival

Other Secondary Objectives:

To evaluate in both arms

CR rate
ORR
DOR
Time to diagnostic (SLiM CRAB) progression
Time to first-line treatment for MM
Safety and tolerability
Pharmacokinetics (PK)
Potential of isatuximab immunogenicity
Clinical outcome assessments (COAs)

location_country:
Greece
Australia
Denmark
France
Japan
Lithuania
Poland
Norway
Canada
Korea, Republic of
Sweden
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Brazil
Czechia
Israel
New Zealand
Spain
Turkey

location_facility:
Investigational Site Number :4100002
Investigational Site Number :3800003
Investigational Site Number :6160008
Investigational Site Number :7240001
Investigational Site Number :3920008
Investigational Site Number :8260001
Investigational Site Number :3480003
Investigational Site Number :2030001
Investigational Site Number :5540003
Investigational Site Number :0360008
Investigational Site Number :7240005
Investigational Site Number :2500011
Investigational Site Number :0360002
Investigational Site Number :3920007
Investigational Site Number :7920005
Investigational Site Number :0360005
Investigational Site Number :3920005
Investigational Site Number :3000001
Investigational Site Number :6160006
Investigational Site Number :2030005
Investigational Site Number :2500007
Investigational Site Number :5540001
Investigational Site Number :3480004
Investigational Site Number :3480001
Investigational Site Number :8260003
Investigational Site Number :1240001
Investigational Site Number :7240002
Investigational Site Number :2030003
Investigational Site Number :7240006
Investigational Site Number :2080002
Investigational Site Number :2080001
Investigational Site Number :2030004
Investigational Site Number :2080005
Investigational Site Number :2760001
Investigational Site Number :3480002
Investigational Site Number :2760002
Investigational Site Number :0760002
Investigational Site Number :7920004
Investigational Site Number :6160005
Investigational Site Number :3760001
Investigational Site Number :1240004
Investigational Site Number :4100001
Investigational Site Number :3920003
Investigational Site Number :3800002
Investigational Site Number :3000003
Investigational Site Number :3920010
Investigational Site Number :8400007
Investigational Site Number :2500005
Investigational Site Number :0360006
Investigational Site Number :2500001
Investigational Site Number :7240004
Investigational Site Number :7920001
Investigational Site Number :2500009
Investigational Site Number :2030002
Investigational Site Number :5780001
Investigational Site Number :3760002
Investigational Site Number :3720002
Investigational Site Number :2500010
Investigational Site Number :3720003
Investigational Site Number :7240003
Investigational Site Number :0360007
Investigational Site Number :7920003
Investigational Site Number :4400001
Investigational Site Number :1240005
Investigational Site Number :3000002
Investigational Site Number :3920006
Investigational Site Number :5780002
Investigational Site Number :2500006
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Investigational Site Number :3760005
Investigational Site Number :0360004
Investigational Site Number :3920002
Investigational Site Number :4100004
Investigational Site Number :2080003
Investigational Site Number :7520003
Investigational Site Number :3920009
Investigational Site Number :5540004
Investigational Site Number :3920004
Investigational Site Number :7920002
Investigational Site Number :3920001
Investigational Site Number :0360001
Investigational Site Number :2500003
Investigational Site Number :3760004
Investigational Site Number :3760003
Investigational Site Number :7240007
Investigational Site Number :2760003
Investigational Site Number :2500002
Investigational Site Number :8400006
Investigational Site Number :3800006
Investigational Site Number :4100003
Investigational Site Number :3800005


status: Withdrawn

study_start_date_type: Anticipated

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Italy
Brazil
Saudi Arabia
Switzerland
France
Australia
Russian Federation
Spain
Turkey
Germany
United Kingdom

location_facility: Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: St.-Petersburg City Clinical Hospital nr 31

location_facility: Hospital de Base de São José do Rio Preto

location_facility: Instituto do cancer -COR -Hospital Mae de Deus

location_facility: Azienda Ospedaliero Universitaria di Ferrara

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

location_facility: Klinikum rechts der Isar an der Technischen Universität München

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

title: A Phase 2, Randomized, Open-label Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)

summary: The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).

status_simplified: Unknown


intervention_type: Other

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:
United States
Germany
France
Czechia
Bulgaria
Israel
Japan
Poland
Hungary
Australia
Ireland
Spain
Canada
United Kingdom

acronym: BE HEARD II

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

summary: The purpose of the study is to test the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)


title: A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Transcatheter Aortic Valve Implantation in Female Patients Who Have Severe Symptomatic Aortic Stenosis Requiring Aortic Valve Replacement

acronym: RHEIA

summary: Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female patients with severe symptomatic aortic stenosis. Patients will be randomized 1:1 to receive either TAVI or SAVR aortic valve replacement. For TAVI procedure, Edwards SAPIEN 3 THV system Model 9600 TFX (20, 23, 26 and 29 mm) or SAPIEN 3 Ultra THV system Model 9750 TFX (20, 23, 26) with the associated transfemoral delivery systems will be sued, for SAVR any commercially available surgical bioprosthetic valve. Patients will undergo the following visits: Screening, Procedure, Post Procedure, Discharge, 30 day, 6 months (telephone contact) and 1 year.

primary_purpose: Other

ReferenceType: derived

ReferenceCitation: Eltchaninoff H, Bonaros N, Prendergast B, Nietlispach F, Vasa-Nicotera M, Chieffo A, Pibarot P, Bramlage P, Sykorova L, Kurucova J, Bax JJ, Windecker S, Dumonteil N, Tchetche D. Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial). Am Heart J. 2020 Oct;228:27-35. doi: 10.1016/j.ahj.2020.06.016. Epub 2020 Jun 30.

family: Eltchaninoff

full_name: Helene Eltchaninoff

given: Helene

sequence: first

family: Bonaros

full_name: Nikolaos Bonaros

given: Nikolaos

sequence: additional

family: Prendergast

full_name: Bernard Prendergast

given: Bernard

family: Nietlispach

full_name: Fabian Nietlispach

given: Fabian

family: Vasa-Nicotera

full_name: Mariuca Vasa-Nicotera

given: Mariuca

family: Chieffo

full_name: Alaide Chieffo

given: Alaide

family: Pibarot

full_name: Philippe Pibarot

given: Philippe

family: Bramlage

full_name: Peter Bramlage

given: Peter

family: Sykorova

full_name: Lenka Sykorova

given: Lenka

family: Kurucova

full_name: Jana Kurucova

given: Jana

family: Bax

full_name: Jeroen J. Bax

given: Jeroen J.

family: Windecker

full_name: Stephan Windecker

given: Stephan

family: Dumonteil

full_name: Nicolas Dumonteil

given: Nicolas

family: Tchetche

full_name: Didier Tchetche

given: Didier

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Heart Journal

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University of Bern - Bern Open Repository and Information System

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: SSS International Clinical Research GmbH

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Cyprus
Finland
France
Czechia
Ireland
Germany
United Kingdom

location_facility: Universitätsklinikum St. Pölten - Lilienfeld

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: IKEM (Institut Klinické a Experimentální Medicíny)

location_facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH

location_facility: CHU de Bordeaux - Hôpital cardiologique du Haut-Lévêqu

location_facility: Universitätsklinik der Ruhr-Universität Bochum

intervention_type: Procedure


ReferenceCitation: Serling-Boyd N, Wallace ZS. Management of primary vasculitides with biologic and novel small molecule medications. Curr Opin Rheumatol. 2021 Jan;33(1):8-14. doi: 10.1097/BOR.0000000000000756. Review.

family: Serling-Boyd

full_name: Naomi Serling-Boyd

given: Naomi

family: Wallace

full_name: Zachary S. Wallace

given: Zachary S.

journal_name: Current Opinion in Rheumatology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

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

lead_sponsor: AstraZeneca

location_country:
Italy
United States
Germany
France
Japan
Israel
Belgium
Canada
United Kingdom

acronym: MANDARA

title: A Randomized, Double-blind, Active-controlled 52-week Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Patients Receiving Standard of Care Therapy

summary:
This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy.

All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC (earlier enrolled patients may therefore be in the OLE for longer than 1 year).


lead_sponsor: Gilead Sciences

location_country:
Italy
Austria
United States
Switzerland
Germany
France
Poland
Australia
Canada

acronym: Falcon

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik fur Innere Medizin I, Haus C, Haus K3

location_facility: "GASTROMED" Kopon, Zmudzinski i Wsp. Sp. J. Spec. Centrum Gastrologii i Endoskopii, Spec. Gabinety Lekarskie

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Inselspital Bern/Klinik fur Viszerale Chirurgie und Medizin/Bauchzentrum

location_facility: Gut P.C., dba Digestive Health Specialists of the Southeast

location_facility: Universitätsspital Zürich/Klinik für Gastroenterologie und Hepatologie

location_facility: Encore Borland-Groover Clinical Research

location_facility: Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin I

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner/Crohn-Colitis-Zentrum

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Clinical Associates in Research Therapeutics of America, LLC

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: Centre Hospitalier Universitaire de Grenoble Alpes

location_facility: Vancouver General Hospital - The Gordon and Leslie Diamond Health Care Centre

location_facility: Medizinische Universitat Wien Klinik fur Innere Medizin III/Abt. fur Gastroenterologie and Hepatologie

title: A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: The primary objective of this study is to demonstrate the efficacy of tilpisertib (formerly GS-4875) compared with placebo control in achieving clinical remission per modified Mayo Clinic score (MCS) in adults with moderately to severely active ulcerative colitis (UC).


ReferenceCitation: Hack SP, Spahn J, Chen M, Cheng AL, Kaseb A, Kudo M, Lee HC, Yopp A, Chow P, Qin S. IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation. Future Oncol. 2020 May;16(15):975-989. doi: 10.2217/fon-2020-0162. Epub 2020 Apr 30. Erratum in: Future Oncol. 2020 Oct;16(29):2371.

name: Genentech, Inc, 1 DNA Way, South San Francisco, CA 94080, USA

family: Hack

full_name: Stephen P Hack

given: Stephen P

family: Spahn

full_name: Jessica Spahn

given: Jessica

name: Department of Hepatobiliary Surgery, Cancer Centre of Sun Yat-sen University, Guangzhou, PR China

family: Chen

full_name: Minshan Chen

given: Minshan

name: National Taiwan University Cancer Center & National Taiwan University Hospital, Taipei, Taiwan

family: Cheng

full_name: Ann-Lii Cheng

given: Ann-Lii

name: Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA

family: Kaseb

full_name: Ahmed Kaseb

given: Ahmed

name: Department of Gastroenterology & Hepatology, Kindai University School of Medicine, Osaka, Japan

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

name: Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

family: Lee

full_name: Han Chu Lee

given: Han Chu

name: Department of Surgery, Division of Surgical Oncology, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA

family: Yopp

full_name: Adam Yopp

given: Adam

name: Division of Surgical Oncology, National Cancer Centre, Singapore

family: Chow

full_name: Pierce Chow

given: Pierce

name: PLA Cancer Center, People’s Liberation Army (PLA) 81 Hospital, Nanjing 210016, PR China

family: Qin

full_name: Shukui Qin

given: Shukui

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

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).

location_country:
Peru
Australia
Belgium
Russian Federation
Taiwan
Costa Rica
France
Japan
Poland
Thailand
Canada
Korea, Republic of
Hong Kong
Netherlands
Singapore
China
Germany
United States
Italy
Austria
Brazil
Mexico
Czechia
New Zealand
Spain
Turkey

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Arcispedale Santa Maria Nuova; Oncologia

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia

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

location_facility: Affiliated Hospital of Bengbu Medical College

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

location_facility: Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: McGill University Health Centre - Glen Site

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hepatologia

location_facility: Zhujiang Hospital, Southern Medical University

location_facility: Ospedale Maggiore Policlinico; U.O.C. di Oncologia Medica

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: Hospital Universitario; Dr. Jose E. Gonzalez

location_facility: Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

location_facility: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept

location_facility: Hopital Robert Debre; Gastro Enterologie

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Hopital de Pontchaillou; Service Hepato Gastro Enterologie

location_facility: Faculdade de Medicina de Ribeirão Preto - Universidade de Sao Paulo

location_facility: Universitätsklinikum Essen; Zentrum f.Innere Medizin Abt.Gastroenterologie u.Hepatologie

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Clinical hospital #1, FBHI Volga district medical center, Federal Medical and Biological Agency

location_facility: Universitätsklinikum Düsseldorf; Klinik für Gastroenterologie Infektologie u. Hepatologie

location_facility: Hospital Universitario Infanta Cristina; Servicio de Oncologia

location_facility: CHU Bordeaux - Hôpital Haut-Lévêque; Service d'Hépato-Gastroentérologie et d Oncologie digestive

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: The University of Texas Southwestern Medical Center at Dallas

location_facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Centrum Onkologii im. Prof. Franciszka Łukaszczyka; Ambulatorium Chemioterapii

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: Inonu University Medical Faculty of Medicine; Medical Oncology Department

location_facility: Taipei Veterans General Hospital; Gastroenterology Division

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie

location_facility: The First Affiliate Hospital of Guangxi Medical University

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies

location_facility: Hopitaux de Brabois - Gastro-Entereologie

location_facility: The Second Affiliated Hospital of Dalian Medical University

location_facility: University of California Irvine Medical Center

location_facility: Gordon & Leslie Diamond Health Care Centre

location_facility: Hospital Clinic I Provincial; Servicio de Digestivo

location_facility: The Second Affiliated Hospital of Anhui Medical University

location_facility: Rush Univ Medical College; Hematology and Onc

location_facility: Harbin Medical University Cancer Hospital

location_facility: The First Affiliated Hospital of China Medical University

location_facility: University Hospital - London Health Sciences Centre

location_facility: The Tumor Hospital of Xinjiang Medical University

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Chiang Rai Prachanukroh Hospital; Department Of Medicine

location_facility: Hospital do Cancer UOPECCAN; Pesquisa Clínica

location_facility: Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie

location_facility: Mengchao Hepatobiliary Hospital Of Fujian Medical University

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Sociedade beneficente de senhoras Hospital Sirio Libanes

location_facility: Queen Mary Hospital; Dept. Of Haematology & Oncology

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Fiona Stanley Hospital - Medical Oncology

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

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I.; Onkologische Gastroenterologie

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Hôpital Avicenne - Groupement Hospitalier Universitaire Paris Seine St Denis; Service d'Hépatologie

location_facility: Dartmouth-Hitchcock Medical Center; Hematology/Oncology

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie

location_facility: Shengjing Hospital of China Medical University

location_facility: Hospital Universitario Reina Sofia; Servicio de Aparato Digestivo

location_facility: Daping Hospital of Third Military Medical University

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Swedish Cancer Institute - Edmonds Campus

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

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

title: A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

summary: This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.


status: Completed

lead_sponsor: Egetis Therapeutics

primary_purpose: Prevention

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

acronym: POLAR-A

location_facility: Mid Essex Hospital Services NHS Trust - Broomfield Hospital

location_facility: National Hospital Organization Osaka National Hospital

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

location_facility: Hôpital Nord Franche-Comté Site du Mittan

location_facility: Seoul National University Bundang Hospital

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Onkodok GmbH / Onkologische Schwerpunktpraxis

location_facility: Chonnam National University Hwasun Hospital

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

study_completion_date_type: Actual

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

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

status_simplified: Completed


title: Personalized Therapy Study - Attain Stability Quad Post-Approval Study

acronym: ASQ

summary: The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Italy
Spain
France
Greece
Portugal
United States
United Kingdom

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Cardiovascular Consultants Medical Group (Van Nuys)

location_facility: North Memorial Heart and Vascular Institute

location_facility: Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

location_facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

location_facility: Azienda ospedaleria Santa Maria della Misericordia di Udine

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Centro Hospitalar Universitário de São João

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: Presidio Ospedaliero Centrale - SS. Annunziata

location_facility: Cardiology Associates of Northeast Arkansas

location_facility: CHRU Brest - Hôpital de la Cavale Blanche

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca Granda

location_facility: New York-Presbyterian Hospital/Columbia University Medical Center

location_facility: Azienda Ospedaliera - Universitaria Consorziale Policlinico di Bari

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General

location_facility: Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

intervention_type: Device


title: A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.

summary: Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)

location_country:
Peru
Malaysia
Greece
Russian Federation
Taiwan
India
France
Japan
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Saudi Arabia
Vietnam
Philippines
Singapore
Hungary
Portugal
China
United States
United Kingdom
Brazil
Mexico
Czechia
Spain
Turkey


lead_sponsor: Merck Sharp & Dohme Corp.

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

location_facility: Kansai Medical University Hospital ( Site 0804)

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

location_facility: Chelsea and Westminster Hospital ( Site 1901)

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

location_facility: Clínica Universitaria Reina Fabiola ( Site 0505)

location_facility: Waverly Hematology Oncology ( Site 0054)

location_facility: Studienzentrum Aschaffenburg ( Site 1575)

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

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

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

location_facility: Stronach Regional Cancer Centre ( Site 0100)

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

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

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

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

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

location_facility: Ege Universitesi Tip Fakultesi ( Site 2109)

location_facility: Columbus Regional Research Institute ( Site 0099)

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

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

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

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

location_facility: Namik Kemal Universitesi Tip Fakultesi ( Site 2100)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)

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

location_facility: Bozeman Health Deaconness Cancer Center ( Site 0053)

location_facility: Chungbuk National University Hospital ( Site 1002)

location_facility: Hospital Britanico de Buenos Aires ( Site 0500)

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

location_facility: Western General Hospital, Edinburgh ( Site 1924)

location_facility: Instituto Medico Rio Cuarto ( Site 0501)

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

location_facility: Helios Klinikum Erfurt GmbH ( Site 1552)

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

location_facility: Medical Center Asklepion LLC ( Site 2243)

location_facility: Complejo Hospitalario de Malaga ( Site 1714)

location_facility: Mount Sinai Hospital Medical Center ( Site 0035)

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

location_facility: Kyiv City Clinical Oncology Centre ( Site 2224)

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

location_facility: Alabama Oncology Bruno Cancer Center ( Site 0001)

location_facility: Hospital Universitario Virgen Macarena ( Site 1712)

location_facility: Southern Medical Day Care Centre ( Site 1200)

location_facility: Thompson Cancer Survival Center ( Site 2812)

location_facility: West Suffolk Hospitals NHS Trust ( Site 1919)

location_facility: Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)

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

location_facility: Centro Oncológico de Rosario ( Site 0507)

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

location_facility: Townsville General Hospital ( Site 1202)

location_facility: Seoul National University Hospital ( Site 1000)

location_facility: MI Odessa Regional Oncological Centre ( Site 2222)

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

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

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

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

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 1572)

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

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2218)

location_facility: Okayama University Hospital ( Site 0810)

location_facility: Boca Raton Regional Hospital ( Site 0018)

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

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

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

location_facility: China Medical University Hospital ( Site 0904)

location_facility: Hospital Italiano de Buenos Aires ( Site 0511)

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

location_facility: Cherkasy Regional Oncology Dispensary ( Site 2225)

location_facility: Osaka International Cancer Institute ( Site 0809)

location_facility: Hospital Universitario 12 de Octubre ( Site 1716)

location_facility: Birmingham Heartlands Hospital ( Site 1910)

location_facility: Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551)

location_facility: Klinikum Wuerzburg Mitte gGmbH ( Site 1559)

location_facility: CLIMERS Clinical Medical Research ( Site 0306)

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

location_facility: Gyeongsang National University Hospital ( Site 1005)

location_facility: Complejo Hospitalario de Jaen ( Site 1713)

location_facility: Centre Hospitalier De Chauny ( Site 1411)

location_facility: Instituto do Cancer do Ceara ( Site 0251)

location_facility: Aichi Cancer Center Hospital ( Site 0803)

location_facility: Erciyes Universitesi Tip Fakultesi ( Site 2108)

location_facility: Universitaetsklinikum Regensburg ( Site 1562)

location_facility: Nova Scotia Health Authority ( Site 0103)

location_facility: MedStar Franklin Square Medical Center ( Site 0044)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 2002)

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

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

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

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

location_facility: Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)

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

location_facility: Kanazawa University Hospital ( Site 0811)

location_facility: SPb Central Clinical Railway Hospital ( Site 2003)

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

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

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

location_facility: Universitaetsklinikum Frankfurt ( Site 1563)

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

location_facility: Colchester General Hospital ( Site 1911)

location_facility: National Cheng Kung University Hospital ( Site 0905)

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

location_facility: MidCentral DHB Palmerston North Hospital ( Site 1102)

location_facility: National Cancer Center Hospital East ( Site 0801)

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

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

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

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

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

location_facility: Kingston Health Sciences Centre ( Site 0102)

location_facility: Hospital Italiano Regional del Sur ( Site 0509)

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

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

location_facility: Central City Clinical Hospital ( Site 2221)

location_facility: Moscow Regional Oncological Dispensary ( Site 2028)

location_facility: Institut De Cancerologie De Lorraine ( Site 1409)

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

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

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

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

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

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)

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

location_facility: Universitaetsmedizin Goettingen ( Site 1557)

location_facility: Niigata Cancer Center Hospital ( Site 0808)

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

location_facility: National Taiwan University Hospital ( Site 0900)

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

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

location_facility: Korea University Guro Hospital ( Site 1008)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 0046)

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

location_facility: Gazi Universitesi Tip Fakultesi ( Site 2104)

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

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

location_facility: Disney Family Cancer Center ( Site 0005)

type: Registry Identifier

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

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

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


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

location_facility: Kansai Medical University Hospital ( Site 0804)

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

location_facility: Bozeman Health Deaconness Cancer Center ( Site 0046)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2204)

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

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

location_facility: Chelsea and Westminster Hospital ( Site 1901)

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

location_facility: Clínica Universitaria Reina Fabiola ( Site 0505)

location_facility: Mount Sinai Hospital Medical Center ( Site 0032)

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

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

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

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

location_facility: Ege Universitesi Tip Fakultesi ( Site 2109)

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

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

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

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

location_facility: Namik Kemal Universitesi Tip Fakultesi ( Site 2100)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)

location_facility: Chungbuk National University Hospital ( Site 1002)

location_facility: Hospital Britanico de Buenos Aires ( Site 0500)

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

location_facility: Western General Hospital, Edinburgh ( Site 1924)

location_facility: Instituto Medico Rio Cuarto ( Site 0501)

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

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

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

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

location_facility: Hospital Clinico Lozano Blesa ( Site 1700)

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

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

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

location_facility: Studienzentrum Aschaffenburg ( Site 1525)

location_facility: Alabama Oncology Bruno Cancer Center ( Site 0001)

location_facility: Medical Center Asklepion LLC ( Site 2234)

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

location_facility: Southern Medical Day Care Centre ( Site 1200)

location_facility: Thompson Cancer Survival Center ( Site 2812)

location_facility: West Suffolk Hospitals NHS Trust ( Site 1919)

location_facility: Universitaetsklinikum Frankfurt ( Site 1513)

location_facility: Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)

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

location_facility: Centro Oncológico de Rosario ( Site 0507)

location_facility: Townsville General Hospital ( Site 1202)

location_facility: MI Odessa Regional Oncological Centre ( Site 2208)

location_facility: Seoul National University Hospital ( Site 1000)

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

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

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

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

location_facility: Instituto do Cancer do Ceara ( Site 0201)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 0041)

location_facility: Okayama University Hospital ( Site 0810)

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

location_facility: Helios Klinikum Erfurt GmbH ( Site 1502)

location_facility: Boca Raton Regional Hospital ( Site 0018)

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

location_facility: China Medical University Hospital ( Site 0904)

location_facility: Hospital Italiano de Buenos Aires ( Site 0511)

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

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

location_facility: Osaka International Cancer Institute ( Site 0809)

location_facility: Hospital Universitario Quiron Madrid ( Site 1701)

location_facility: Birmingham Heartlands Hospital ( Site 1910)

location_facility: Hospital Clinico Universitario de Valencia ( Site 1706)

location_facility: Universitaetsmedizin Goettingen ( Site 1507)

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

location_facility: Pneumologische Lehrklinik Universitaet Goettingen ( Site 1501)

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

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

location_facility: Gyeongsang National University Hospital ( Site 1005)

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

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

location_facility: Centre Hospitalier De Chauny ( Site 1411)

location_facility: Erciyes Universitesi Tip Fakultesi ( Site 2108)

location_facility: Aichi Cancer Center Hospital ( Site 0803)

location_facility: Centro de Hematologia e Oncologia ( Site 0205)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 2002)

location_facility: Stronach Regional Cancer Centre ( Site 0101)

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

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

location_facility: Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)

location_facility: Kanazawa University Hospital ( Site 0811)

location_facility: SPb Central Clinical Railway Hospital ( Site 2003)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 2211)

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

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

location_facility: Klinikum Wuerzburg Mitte gGmbH ( Site 1509)

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

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

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

location_facility: Medstar Good Samaritan Hospital ( Site 0040)

location_facility: Waverly Hematology Oncology ( Site 0081)

location_facility: Colchester General Hospital ( Site 1911)

location_facility: National Cheng Kung University Hospital ( Site 0905)

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

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

location_facility: Columbus Regional Research Institute ( Site 0098)

location_facility: MidCentral DHB Palmerston North Hospital ( Site 1102)

location_facility: National Cancer Center Hospital East ( Site 0801)

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

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

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

location_facility: Central City Clinical Hospital ( Site 2207)

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

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

location_facility: Hospital Italiano Regional del Sur ( Site 0509)

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

location_facility: Institut De Cancerologie De Lorraine ( Site 1409)

location_facility: Moscow Regional Oncological Dispensary ( Site 2028)

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

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

location_facility: Health Sciences North Research Institute ( Site 0115)

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

location_facility: Kyiv City Clinical Oncology Centre ( Site 2210)

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

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 1522)

location_facility: Universitaetsklinikum Regensburg ( Site 1512)

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

location_facility: Saint Gallen Instituto de Oncologia ( Site 0206)

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

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


title: A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache

summary: Study 20170703 is a phase 4, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of erenumab against placebo in subjects with chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are diagnosed with medication overuse headache (MOH).

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Italy
Austria
Spain
Finland
France
Czechia
Poland
Hungary
Australia
Portugal
United States
United Kingdom

location_facility: The George Washington Medical Faculty Associates

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna Ospedale Bellaria

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Spolka Jawna

location_facility: Clinical Trial Investigator Clinical Research Center

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Centre Hospitalier Universitaire de Nice - Hopital de Cimiez

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Konventhospital der Barmherzigen Brueder Linz

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

location_facility: Emerald Coast Center for Neurological Disorders

location_facility: Fondazione Istituto Neurologico Nazionale C Mondino IRCCS

location_facility: Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Jerzy Petz Mediq Niepubliczny Zaklad Opieki Zdrowotnej

location_facility: University of Miami Miller School of Medicine

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro

location_facility: Hospices Civils de Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Michigan Head Pain and Neurological Institute

location_facility: Hospital Professor Doutor Fernando Fonseca, EPE

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Clinical Research Center Spzoo Medic-R Spolka Komandytowa

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Centre Hospitalier Universitaire Saint-Etienne - Hopital Nord